Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.

In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.

For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.

All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
 

Female sex and obesity major risk factors for not recovering

Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.

“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.

The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
 

Several inflammatory mediators increased

An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.

They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.

“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.

“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.

There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.

“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.

They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”

They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”

They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”

A version of this article first appeared on Medscape UK.

One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.

In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.

For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.

All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
 

Female sex and obesity major risk factors for not recovering

Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.

“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.

The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
 

Several inflammatory mediators increased

An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.

They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.

“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.

“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.

There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.

“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.

They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”

They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”

They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”

A version of this article first appeared on Medscape UK.

One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.

In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.

For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.

All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
 

Female sex and obesity major risk factors for not recovering

Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.

“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.

The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
 

Several inflammatory mediators increased

An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.

They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.

“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.

“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.

There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.

“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.

They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”

They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”

They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”

A version of this article first appeared on Medscape UK.

Climate-informed clinical encounters have the potential to enhance pediatric care in a variety of ways, according to Aaron Bernstein, MD, of Boston Children’s Hospital.

“Each primary care visit offers opportunities to screen for and support children burdened with risks to health that are increasingly intense due to climate change,” Rebecca P. Philipsborn, MD, of Emory University, Atlanta, and colleagues wrote in “A pediatrician’s guide to climate change–informed primary care,” on which Dr. Bernstein served as corresponding author (Curr Probl Pediatr Adolesc Health Care. 2021 June. doi: 10.1016/j.cppeds.2021.101027).

In a presentation at the annual meeting of the Pediatric Academic Societies, Dr. Bernstein highlighted five components of climate-informed pediatric care mentioned in the article: climate-informed screening, health promotion that includes health and climate benefits, care management that anticipates climate risks for at-risk children, climate-informed anticipatory guidance, and engagement with community resources and advocacy.

Pediatricians can incorporate climate-related issues into screening protocols by asking patients about their home environment, Dr. Bernstein said. Potential questions to ask include whether the family has air conditioning in the home, and whether they are concerned about being able to pay the bill if they use air conditioning, he said.

Health promotion discussions during clinical encounters can emphasize that eating more fruits and vegetables not only is good for the health of the child and the whole family, but “also is good for the planet we live on,” he said.

Care management strategies should anticipate climate risks for at-risk children, such those with complex or chronic medical conditions, and outdoor athletes for whom air quality might be an issue, he said.

Medication management has a climate-informed aspect, Dr. Bernstein said. “How safe are the medications you prescribe?” he asked. During the summer months, the relative risk of hospitalization with heat exposure is increased for a range of drugs including ACE inhibitors (RR 1.42), loop diuretics (RR 1.52), stimulants (RR 1.53), anticholinergics (RR 1.26), antipsychotics (RR 1.51), and beta-blockers (RR 1.08), he noted.

For children who play outdoor sports, previous studies suggest they acclimatize for approximately 7 days if traveling prior to vigorous exercise outdoors. “Monitor the heat index and limit the intensity or length of exercise on extreme heat index days,” Dr. Bernstein said. He emphasized the need to remind children and parents to try to limit intense physical activity to the coolest parts of the day, before 10 a.m. and after 4 p.m., to wear sunscreen and light-colored, lightweight clothing, and to drink 5-8 ounces of fluid every 20 minutes during exercise.

Approximately 12% of all-cause attributable fractions of emergency department visits are associated with heat exposure, Dr. Bernstein added. He recommended that pediatricians and patients be aware of airnow.gov and iqair.com as resources to monitor air quality. Pay attention to the heat index, which factors in humidity and presents the real-feel temperature, not just the thermometer reading.

Last but not least, Dr. Bernstein explained that pediatricians can use a clinical visit to ask adolescent patients about civic engagement, and offer resources for those who want to learn more about climate change, such as climatechangeresources.org/organizations-kids/.

For more detailed guidance, Dr. Bernstein recommended “A pediatrician’s guide to climate change–informed primary care.”

Use websites and handouts

Including climate issues in pediatric visits is definitely important, Suzanne Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview.

“Some questions are more critical in warm weather environments where children are at higher risk for dehydration and heat exposure,” said Dr. Boulter, who was not involved with the guide preparation. “The list of suggestions for participation in outdoor sports in hot weather is comprehensive, and the data on ER visits in summer months is surprising,” she noted. However, some of the data could have included more explanation, such as what air quality actually measures, and the difference between ambient temperature and heat index, and how they are calculated, she noted.

Questions about diet, air conditioning, and backup power sources may be covered in other areas of the pediatric visit, or on questionnaires prior to the visit, Dr. Boulter added.

The main barrier to incorporating climate-related information during the pediatric visit is the limited time allotted for the visit and number of topics to address, said Dr. Boulter. “Pediatric practices that have websites could post seasonal reminders about sports participation health in hot weather, or have printed brief handouts for patients in the office,” she noted. Alternatively, guidance about sports and the impact of climate could easily be given as a short handout to families during the health visit, she said.

Future research might include a focus on assessing families’ knowledge and behavior before and after climate change counseling, Dr. Boulter added.

Dr. Bernstein and Dr. Boulter had no financial conflicts to disclose. Dr. Boulter serves on the editorial advisory board of Pediatric News.

Climate-informed clinical encounters have the potential to enhance pediatric care in a variety of ways, according to Aaron Bernstein, MD, of Boston Children’s Hospital.

“Each primary care visit offers opportunities to screen for and support children burdened with risks to health that are increasingly intense due to climate change,” Rebecca P. Philipsborn, MD, of Emory University, Atlanta, and colleagues wrote in “A pediatrician’s guide to climate change–informed primary care,” on which Dr. Bernstein served as corresponding author (Curr Probl Pediatr Adolesc Health Care. 2021 June. doi: 10.1016/j.cppeds.2021.101027).

In a presentation at the annual meeting of the Pediatric Academic Societies, Dr. Bernstein highlighted five components of climate-informed pediatric care mentioned in the article: climate-informed screening, health promotion that includes health and climate benefits, care management that anticipates climate risks for at-risk children, climate-informed anticipatory guidance, and engagement with community resources and advocacy.

Pediatricians can incorporate climate-related issues into screening protocols by asking patients about their home environment, Dr. Bernstein said. Potential questions to ask include whether the family has air conditioning in the home, and whether they are concerned about being able to pay the bill if they use air conditioning, he said.

Health promotion discussions during clinical encounters can emphasize that eating more fruits and vegetables not only is good for the health of the child and the whole family, but “also is good for the planet we live on,” he said.

Care management strategies should anticipate climate risks for at-risk children, such those with complex or chronic medical conditions, and outdoor athletes for whom air quality might be an issue, he said.

Medication management has a climate-informed aspect, Dr. Bernstein said. “How safe are the medications you prescribe?” he asked. During the summer months, the relative risk of hospitalization with heat exposure is increased for a range of drugs including ACE inhibitors (RR 1.42), loop diuretics (RR 1.52), stimulants (RR 1.53), anticholinergics (RR 1.26), antipsychotics (RR 1.51), and beta-blockers (RR 1.08), he noted.

For children who play outdoor sports, previous studies suggest they acclimatize for approximately 7 days if traveling prior to vigorous exercise outdoors. “Monitor the heat index and limit the intensity or length of exercise on extreme heat index days,” Dr. Bernstein said. He emphasized the need to remind children and parents to try to limit intense physical activity to the coolest parts of the day, before 10 a.m. and after 4 p.m., to wear sunscreen and light-colored, lightweight clothing, and to drink 5-8 ounces of fluid every 20 minutes during exercise.

Approximately 12% of all-cause attributable fractions of emergency department visits are associated with heat exposure, Dr. Bernstein added. He recommended that pediatricians and patients be aware of airnow.gov and iqair.com as resources to monitor air quality. Pay attention to the heat index, which factors in humidity and presents the real-feel temperature, not just the thermometer reading.

Last but not least, Dr. Bernstein explained that pediatricians can use a clinical visit to ask adolescent patients about civic engagement, and offer resources for those who want to learn more about climate change, such as climatechangeresources.org/organizations-kids/.

For more detailed guidance, Dr. Bernstein recommended “A pediatrician’s guide to climate change–informed primary care.”

Use websites and handouts

Including climate issues in pediatric visits is definitely important, Suzanne Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview.

“Some questions are more critical in warm weather environments where children are at higher risk for dehydration and heat exposure,” said Dr. Boulter, who was not involved with the guide preparation. “The list of suggestions for participation in outdoor sports in hot weather is comprehensive, and the data on ER visits in summer months is surprising,” she noted. However, some of the data could have included more explanation, such as what air quality actually measures, and the difference between ambient temperature and heat index, and how they are calculated, she noted.

Questions about diet, air conditioning, and backup power sources may be covered in other areas of the pediatric visit, or on questionnaires prior to the visit, Dr. Boulter added.

The main barrier to incorporating climate-related information during the pediatric visit is the limited time allotted for the visit and number of topics to address, said Dr. Boulter. “Pediatric practices that have websites could post seasonal reminders about sports participation health in hot weather, or have printed brief handouts for patients in the office,” she noted. Alternatively, guidance about sports and the impact of climate could easily be given as a short handout to families during the health visit, she said.

Future research might include a focus on assessing families’ knowledge and behavior before and after climate change counseling, Dr. Boulter added.

Dr. Bernstein and Dr. Boulter had no financial conflicts to disclose. Dr. Boulter serves on the editorial advisory board of Pediatric News.

Climate-informed clinical encounters have the potential to enhance pediatric care in a variety of ways, according to Aaron Bernstein, MD, of Boston Children’s Hospital.

“Each primary care visit offers opportunities to screen for and support children burdened with risks to health that are increasingly intense due to climate change,” Rebecca P. Philipsborn, MD, of Emory University, Atlanta, and colleagues wrote in “A pediatrician’s guide to climate change–informed primary care,” on which Dr. Bernstein served as corresponding author (Curr Probl Pediatr Adolesc Health Care. 2021 June. doi: 10.1016/j.cppeds.2021.101027).

In a presentation at the annual meeting of the Pediatric Academic Societies, Dr. Bernstein highlighted five components of climate-informed pediatric care mentioned in the article: climate-informed screening, health promotion that includes health and climate benefits, care management that anticipates climate risks for at-risk children, climate-informed anticipatory guidance, and engagement with community resources and advocacy.

Pediatricians can incorporate climate-related issues into screening protocols by asking patients about their home environment, Dr. Bernstein said. Potential questions to ask include whether the family has air conditioning in the home, and whether they are concerned about being able to pay the bill if they use air conditioning, he said.

Health promotion discussions during clinical encounters can emphasize that eating more fruits and vegetables not only is good for the health of the child and the whole family, but “also is good for the planet we live on,” he said.

Care management strategies should anticipate climate risks for at-risk children, such those with complex or chronic medical conditions, and outdoor athletes for whom air quality might be an issue, he said.

Medication management has a climate-informed aspect, Dr. Bernstein said. “How safe are the medications you prescribe?” he asked. During the summer months, the relative risk of hospitalization with heat exposure is increased for a range of drugs including ACE inhibitors (RR 1.42), loop diuretics (RR 1.52), stimulants (RR 1.53), anticholinergics (RR 1.26), antipsychotics (RR 1.51), and beta-blockers (RR 1.08), he noted.

For children who play outdoor sports, previous studies suggest they acclimatize for approximately 7 days if traveling prior to vigorous exercise outdoors. “Monitor the heat index and limit the intensity or length of exercise on extreme heat index days,” Dr. Bernstein said. He emphasized the need to remind children and parents to try to limit intense physical activity to the coolest parts of the day, before 10 a.m. and after 4 p.m., to wear sunscreen and light-colored, lightweight clothing, and to drink 5-8 ounces of fluid every 20 minutes during exercise.

Approximately 12% of all-cause attributable fractions of emergency department visits are associated with heat exposure, Dr. Bernstein added. He recommended that pediatricians and patients be aware of airnow.gov and iqair.com as resources to monitor air quality. Pay attention to the heat index, which factors in humidity and presents the real-feel temperature, not just the thermometer reading.

Last but not least, Dr. Bernstein explained that pediatricians can use a clinical visit to ask adolescent patients about civic engagement, and offer resources for those who want to learn more about climate change, such as climatechangeresources.org/organizations-kids/.

For more detailed guidance, Dr. Bernstein recommended “A pediatrician’s guide to climate change–informed primary care.”

Use websites and handouts

Including climate issues in pediatric visits is definitely important, Suzanne Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview.

“Some questions are more critical in warm weather environments where children are at higher risk for dehydration and heat exposure,” said Dr. Boulter, who was not involved with the guide preparation. “The list of suggestions for participation in outdoor sports in hot weather is comprehensive, and the data on ER visits in summer months is surprising,” she noted. However, some of the data could have included more explanation, such as what air quality actually measures, and the difference between ambient temperature and heat index, and how they are calculated, she noted.

Questions about diet, air conditioning, and backup power sources may be covered in other areas of the pediatric visit, or on questionnaires prior to the visit, Dr. Boulter added.

The main barrier to incorporating climate-related information during the pediatric visit is the limited time allotted for the visit and number of topics to address, said Dr. Boulter. “Pediatric practices that have websites could post seasonal reminders about sports participation health in hot weather, or have printed brief handouts for patients in the office,” she noted. Alternatively, guidance about sports and the impact of climate could easily be given as a short handout to families during the health visit, she said.

Future research might include a focus on assessing families’ knowledge and behavior before and after climate change counseling, Dr. Boulter added.

Dr. Bernstein and Dr. Boulter had no financial conflicts to disclose. Dr. Boulter serves on the editorial advisory board of Pediatric News.

Testing the DNA of antimicrobial-resistant Plasmodium falciparum in the blood of travelers from malaria-endemic regions may help researchers monitor how drug resistance changes over time, a study from Canada reports.

“Malaria remains the deadliest vector-borne infectious disease worldwide. Plasmodium spp., most commonly P. falciparum, are responsible for [approximately] 229 million cases and 500,000 deaths from malaria annually,” the authors write in Emerging Infectious Diseases.

“Our findings demonstrate an absence of genetic markers of resistance to the most powerful antimalarials on the planet – the artemisinins – in potentially deadly malaria imported primarily from sub-Saharan Africa over time. This is good news,” senior study author Andrea K. Boggild, MD, MSc, DTMH, told this news organization.

“We also showed that over 90% of falciparum malaria imports were resistant to the proguanil component of the fixed drug combination atovaquone-proguanil, a popular oral antimalarial that is first-line treatment for uncomplicated malaria in Canada,” Dr. Boggild, an associate professor in the department of medicine at the University of Toronto, Canada, added in an email. “We documented no genetic markers of atovaquone resistance.”
 

Search for global patterns of emerging drug resistance

Dr. Boggild, the medical director of the tropical disease unit at Toronto General Hospital, and colleagues analyzed 243 whole-blood specimens that contained P. falciparum and no other Plasmodium species from the malaria biobank at the Public Health Ontario Laboratory in Toronto. They analyzed specimens from the years 2008-2009, 2013-2014, and 2017-2018 from patients ranging in age from 3 to 88 years. Of the 186 patients with a documented travel history, 81 had traveled in West Africa, the most common region, and 40 in Nigeria, the most common country. Five specimens came from travelers to Southeast Asia, and one came from a traveler to the Caribbean.

The researchers extracted DNA from whole blood and detected the parasite’s DNA by real-time quantitative polymerase chain reaction (qPCR). They analyzed 23 different single-nucleotide polymorphisms (SNPs) in six genes, and quantified the prevalence of resistance markers, including genes that provoke resistance to the most common antimalarial drugs: chloroquine, mefloquine, atovaquone/proguanil, and the artemisinins.

They analyzed SNPs at atpase6 (pfATPase6), pfcrt (chloroquine resistance transporter, cytb (cytochrome b), dhfr (dihydrofolate reductase), dhps (dihydropteroate synthetase), mdr1 (multidrug resistance protein) and mdr1 copy number, and kelch13 (kelch protein gene on chromosome 13).

Over time, they detected increasing mutant genotypes for dhfr S108N (P = .001) and dhps A613T (P = .029) but decreasing mutant genotypes for mdr1 N86Y (P < .001), D1246Y (P = .003), pfcrt K76T (P = .011), and pfcrt 74-75 (P = .014). They found no kelch13 mutations. They detected fewer mutations indicating chloroquine resistance over time, suggesting less chloroquine pressure in specimens from travelers to Africa, but mutations that provided proguanil resistance increased.

“Antimalarial resistance – particularly resistance to the powerful artemisinins – continues to expand globally, and it is important to conduct routine surveillance for resistant parasites in order to inform appropriate prevention and treatment guidelines,” Dr. Boggild explained. “It cannot be presumed that a drug’s efficacy will be durable over time given the global landscape of antimalarial resistance.”

Dr. Boggild acknowledged limitations to the study, including incomplete travel history in about half of the patients, relatively few patients from Southeast Asia, and the small sample set.

“Clinicians caring for travelers before or after travel should familiarize themselves with the options for malaria prevention and treatment and understand the risk–benefit profile of each drug,” Dr. Boggild advised. 

“Resistance to proguanil means that we are reliant on the partner drug atovaquone for the antimalarial action of this formulation, which is effective only when taken with food,” she added.

Anne N. Cowell, MD, MPH, of the division of infectious diseases at the University of California, San Diego, was not surprised by the findings.

“The study demonstrates how quickly malaria parasites adapt and evolve to survive changes in malaria treatment,” Dr. Cowell, who was not involved in the study, told this news organization.

“These changes reflect changing malaria treatment and thus drug pressure during the time period,” she said in an email. “Because the majority of the clinical samples with a known travel history came from West Africa, and there was no clear evidence of artemisinin resistance in the area during the final time period studied, it is not surprising that they did not find kelch13 resistance mutations.

“The increase in mutations associated with proguanil resistance is concerning because atovaquone-proguanil is frequently used for prophylaxis during travel,” Dr. Cowell added. “There is no widespread evidence of resistance in travelers at this time, but it warrants monitoring.”

Sean C. Murphy, MD, PhD, an associate professor of laboratory medicine and the director of the malaria molecular diagnostic laboratory at the University of Washington in Seattle, also was not surprised by the study’s results.

“It may be just a matter of time before evidence of artemisinin resistance crops up among returning travelers,” he said in an email. “When that happens, we may lose the opportunity to easily use common go-to drugs like atovaquone/proguanil to treat these patients.

“The biggest takeaway of this study is the reminder that drug-resistant malaria (including the future potential for artemisinin-resistant malaria) is just an airplane flight or two away from nonendemic places like Canada and the United States,” Dr. Murphy noted. He was not involved with this Canadian study.

“Continued investment is needed to support malaria control, drug resistance monitoring, and vaccine efforts in order to fight this relentless, terrible parasite,” he urged.

The Project Initiation Fund of Public Health Ontario funded the study. The study authors, Dr. Cowell, and Dr. Murphy have disclosed no relevant financial relationships.  

A version of this article first appeared on Medscape.com.

Testing the DNA of antimicrobial-resistant Plasmodium falciparum in the blood of travelers from malaria-endemic regions may help researchers monitor how drug resistance changes over time, a study from Canada reports.

“Malaria remains the deadliest vector-borne infectious disease worldwide. Plasmodium spp., most commonly P. falciparum, are responsible for [approximately] 229 million cases and 500,000 deaths from malaria annually,” the authors write in Emerging Infectious Diseases.

“Our findings demonstrate an absence of genetic markers of resistance to the most powerful antimalarials on the planet – the artemisinins – in potentially deadly malaria imported primarily from sub-Saharan Africa over time. This is good news,” senior study author Andrea K. Boggild, MD, MSc, DTMH, told this news organization.

“We also showed that over 90% of falciparum malaria imports were resistant to the proguanil component of the fixed drug combination atovaquone-proguanil, a popular oral antimalarial that is first-line treatment for uncomplicated malaria in Canada,” Dr. Boggild, an associate professor in the department of medicine at the University of Toronto, Canada, added in an email. “We documented no genetic markers of atovaquone resistance.”
 

Search for global patterns of emerging drug resistance

Dr. Boggild, the medical director of the tropical disease unit at Toronto General Hospital, and colleagues analyzed 243 whole-blood specimens that contained P. falciparum and no other Plasmodium species from the malaria biobank at the Public Health Ontario Laboratory in Toronto. They analyzed specimens from the years 2008-2009, 2013-2014, and 2017-2018 from patients ranging in age from 3 to 88 years. Of the 186 patients with a documented travel history, 81 had traveled in West Africa, the most common region, and 40 in Nigeria, the most common country. Five specimens came from travelers to Southeast Asia, and one came from a traveler to the Caribbean.

The researchers extracted DNA from whole blood and detected the parasite’s DNA by real-time quantitative polymerase chain reaction (qPCR). They analyzed 23 different single-nucleotide polymorphisms (SNPs) in six genes, and quantified the prevalence of resistance markers, including genes that provoke resistance to the most common antimalarial drugs: chloroquine, mefloquine, atovaquone/proguanil, and the artemisinins.

They analyzed SNPs at atpase6 (pfATPase6), pfcrt (chloroquine resistance transporter, cytb (cytochrome b), dhfr (dihydrofolate reductase), dhps (dihydropteroate synthetase), mdr1 (multidrug resistance protein) and mdr1 copy number, and kelch13 (kelch protein gene on chromosome 13).

Over time, they detected increasing mutant genotypes for dhfr S108N (P = .001) and dhps A613T (P = .029) but decreasing mutant genotypes for mdr1 N86Y (P < .001), D1246Y (P = .003), pfcrt K76T (P = .011), and pfcrt 74-75 (P = .014). They found no kelch13 mutations. They detected fewer mutations indicating chloroquine resistance over time, suggesting less chloroquine pressure in specimens from travelers to Africa, but mutations that provided proguanil resistance increased.

“Antimalarial resistance – particularly resistance to the powerful artemisinins – continues to expand globally, and it is important to conduct routine surveillance for resistant parasites in order to inform appropriate prevention and treatment guidelines,” Dr. Boggild explained. “It cannot be presumed that a drug’s efficacy will be durable over time given the global landscape of antimalarial resistance.”

Dr. Boggild acknowledged limitations to the study, including incomplete travel history in about half of the patients, relatively few patients from Southeast Asia, and the small sample set.

“Clinicians caring for travelers before or after travel should familiarize themselves with the options for malaria prevention and treatment and understand the risk–benefit profile of each drug,” Dr. Boggild advised. 

“Resistance to proguanil means that we are reliant on the partner drug atovaquone for the antimalarial action of this formulation, which is effective only when taken with food,” she added.

Anne N. Cowell, MD, MPH, of the division of infectious diseases at the University of California, San Diego, was not surprised by the findings.

“The study demonstrates how quickly malaria parasites adapt and evolve to survive changes in malaria treatment,” Dr. Cowell, who was not involved in the study, told this news organization.

“These changes reflect changing malaria treatment and thus drug pressure during the time period,” she said in an email. “Because the majority of the clinical samples with a known travel history came from West Africa, and there was no clear evidence of artemisinin resistance in the area during the final time period studied, it is not surprising that they did not find kelch13 resistance mutations.

“The increase in mutations associated with proguanil resistance is concerning because atovaquone-proguanil is frequently used for prophylaxis during travel,” Dr. Cowell added. “There is no widespread evidence of resistance in travelers at this time, but it warrants monitoring.”

Sean C. Murphy, MD, PhD, an associate professor of laboratory medicine and the director of the malaria molecular diagnostic laboratory at the University of Washington in Seattle, also was not surprised by the study’s results.

“It may be just a matter of time before evidence of artemisinin resistance crops up among returning travelers,” he said in an email. “When that happens, we may lose the opportunity to easily use common go-to drugs like atovaquone/proguanil to treat these patients.

“The biggest takeaway of this study is the reminder that drug-resistant malaria (including the future potential for artemisinin-resistant malaria) is just an airplane flight or two away from nonendemic places like Canada and the United States,” Dr. Murphy noted. He was not involved with this Canadian study.

“Continued investment is needed to support malaria control, drug resistance monitoring, and vaccine efforts in order to fight this relentless, terrible parasite,” he urged.

The Project Initiation Fund of Public Health Ontario funded the study. The study authors, Dr. Cowell, and Dr. Murphy have disclosed no relevant financial relationships.  

A version of this article first appeared on Medscape.com.

Testing the DNA of antimicrobial-resistant Plasmodium falciparum in the blood of travelers from malaria-endemic regions may help researchers monitor how drug resistance changes over time, a study from Canada reports.

“Malaria remains the deadliest vector-borne infectious disease worldwide. Plasmodium spp., most commonly P. falciparum, are responsible for [approximately] 229 million cases and 500,000 deaths from malaria annually,” the authors write in Emerging Infectious Diseases.

“Our findings demonstrate an absence of genetic markers of resistance to the most powerful antimalarials on the planet – the artemisinins – in potentially deadly malaria imported primarily from sub-Saharan Africa over time. This is good news,” senior study author Andrea K. Boggild, MD, MSc, DTMH, told this news organization.

“We also showed that over 90% of falciparum malaria imports were resistant to the proguanil component of the fixed drug combination atovaquone-proguanil, a popular oral antimalarial that is first-line treatment for uncomplicated malaria in Canada,” Dr. Boggild, an associate professor in the department of medicine at the University of Toronto, Canada, added in an email. “We documented no genetic markers of atovaquone resistance.”
 

Search for global patterns of emerging drug resistance

Dr. Boggild, the medical director of the tropical disease unit at Toronto General Hospital, and colleagues analyzed 243 whole-blood specimens that contained P. falciparum and no other Plasmodium species from the malaria biobank at the Public Health Ontario Laboratory in Toronto. They analyzed specimens from the years 2008-2009, 2013-2014, and 2017-2018 from patients ranging in age from 3 to 88 years. Of the 186 patients with a documented travel history, 81 had traveled in West Africa, the most common region, and 40 in Nigeria, the most common country. Five specimens came from travelers to Southeast Asia, and one came from a traveler to the Caribbean.

The researchers extracted DNA from whole blood and detected the parasite’s DNA by real-time quantitative polymerase chain reaction (qPCR). They analyzed 23 different single-nucleotide polymorphisms (SNPs) in six genes, and quantified the prevalence of resistance markers, including genes that provoke resistance to the most common antimalarial drugs: chloroquine, mefloquine, atovaquone/proguanil, and the artemisinins.

They analyzed SNPs at atpase6 (pfATPase6), pfcrt (chloroquine resistance transporter, cytb (cytochrome b), dhfr (dihydrofolate reductase), dhps (dihydropteroate synthetase), mdr1 (multidrug resistance protein) and mdr1 copy number, and kelch13 (kelch protein gene on chromosome 13).

Over time, they detected increasing mutant genotypes for dhfr S108N (P = .001) and dhps A613T (P = .029) but decreasing mutant genotypes for mdr1 N86Y (P < .001), D1246Y (P = .003), pfcrt K76T (P = .011), and pfcrt 74-75 (P = .014). They found no kelch13 mutations. They detected fewer mutations indicating chloroquine resistance over time, suggesting less chloroquine pressure in specimens from travelers to Africa, but mutations that provided proguanil resistance increased.

“Antimalarial resistance – particularly resistance to the powerful artemisinins – continues to expand globally, and it is important to conduct routine surveillance for resistant parasites in order to inform appropriate prevention and treatment guidelines,” Dr. Boggild explained. “It cannot be presumed that a drug’s efficacy will be durable over time given the global landscape of antimalarial resistance.”

Dr. Boggild acknowledged limitations to the study, including incomplete travel history in about half of the patients, relatively few patients from Southeast Asia, and the small sample set.

“Clinicians caring for travelers before or after travel should familiarize themselves with the options for malaria prevention and treatment and understand the risk–benefit profile of each drug,” Dr. Boggild advised. 

“Resistance to proguanil means that we are reliant on the partner drug atovaquone for the antimalarial action of this formulation, which is effective only when taken with food,” she added.

Anne N. Cowell, MD, MPH, of the division of infectious diseases at the University of California, San Diego, was not surprised by the findings.

“The study demonstrates how quickly malaria parasites adapt and evolve to survive changes in malaria treatment,” Dr. Cowell, who was not involved in the study, told this news organization.

“These changes reflect changing malaria treatment and thus drug pressure during the time period,” she said in an email. “Because the majority of the clinical samples with a known travel history came from West Africa, and there was no clear evidence of artemisinin resistance in the area during the final time period studied, it is not surprising that they did not find kelch13 resistance mutations.

“The increase in mutations associated with proguanil resistance is concerning because atovaquone-proguanil is frequently used for prophylaxis during travel,” Dr. Cowell added. “There is no widespread evidence of resistance in travelers at this time, but it warrants monitoring.”

Sean C. Murphy, MD, PhD, an associate professor of laboratory medicine and the director of the malaria molecular diagnostic laboratory at the University of Washington in Seattle, also was not surprised by the study’s results.

“It may be just a matter of time before evidence of artemisinin resistance crops up among returning travelers,” he said in an email. “When that happens, we may lose the opportunity to easily use common go-to drugs like atovaquone/proguanil to treat these patients.

“The biggest takeaway of this study is the reminder that drug-resistant malaria (including the future potential for artemisinin-resistant malaria) is just an airplane flight or two away from nonendemic places like Canada and the United States,” Dr. Murphy noted. He was not involved with this Canadian study.

“Continued investment is needed to support malaria control, drug resistance monitoring, and vaccine efforts in order to fight this relentless, terrible parasite,” he urged.

The Project Initiation Fund of Public Health Ontario funded the study. The study authors, Dr. Cowell, and Dr. Murphy have disclosed no relevant financial relationships.  

A version of this article first appeared on Medscape.com.

Political elections can be hard on the heart, suggests a study that showed a substantial uptick in hospital admissions for acute cardiovascular conditions immediately after the 2020 American presidential election.

The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.

The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.

“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.

The study was published in the April issue of JAMA Network Open.
 

Stress and the heart

In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.

Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.

There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).

There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).

There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.

The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.

“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.

Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.

However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.

There is growing evidence that psychological health contributes to CVD.

Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.

The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.

Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Political elections can be hard on the heart, suggests a study that showed a substantial uptick in hospital admissions for acute cardiovascular conditions immediately after the 2020 American presidential election.

The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.

The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.

“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.

The study was published in the April issue of JAMA Network Open.
 

Stress and the heart

In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.

Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.

There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).

There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).

There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.

The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.

“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.

Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.

However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.

There is growing evidence that psychological health contributes to CVD.

Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.

The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.

Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Political elections can be hard on the heart, suggests a study that showed a substantial uptick in hospital admissions for acute cardiovascular conditions immediately after the 2020 American presidential election.

The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.

The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.

“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.

The study was published in the April issue of JAMA Network Open.
 

Stress and the heart

In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.

Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.

There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).

There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).

There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.

The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.

“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.

Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.

However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.

There is growing evidence that psychological health contributes to CVD.

Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.

The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.

Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Caregivers who brought suicidal adolescents to the emergency department reported safer gun storage practices after firearm counseling – a crucial way to cut gun deaths among children, according to researchers from Cincinnati Children’s Hospital.

In the study, which took place between June 2021 and Feb 2022, gun safety counseling and handouts were provided to 99 families of children who had come to the ED with mental health problems. A separate set of 101 families in similar situations received counseling and handouts, along with two cable-style gun locks.

Four weeks later, parents in both groups reported an increase in safe storage practices in which they locked away all guns in the household. Those offered only counseling increased safe storage by 7.2% – from 89.9% to 97.1%.

The gains were greater for families that received locks in addition to counseling. The number of those who locked away all guns rose from 82.2% to 98.5% – a 16.3% increase. (Roughly one-third of families in both arms of the study were lost to follow-up, according to the researchers, which left 68 families in each group for analysis.)

Several caregivers in each group reported that guns had been removed entirely from the home, and more than 60% in each group said they had bought additional gun locks to secure their weapons.

“The main point of our study is that just-in-time counseling is very effective in helping these families of children with mental health concerns in securing all their guns, and an emergency department visit is a great time to do that,” said Bijan Ketabchi, MD, a clinical fellow in the division of emergency medicine at Cincinnati Children’s Hospital Medical Center, who presented the findings at the Pediatric Academic Societies annual meeting.

Dr. Ketabchi said his department sees 500-700 children each month with mental health concerns, most commonly depression. The mean age of adolescent patients in the study was 14 years.

Suicide is the second-leading cause of death among children in the United States. Both pediatric suicides and firearm suicides have increased in the past 2 decades, Dr. Ketabchi said. The number of youth suicides who use guns has risen 90% since 2008. One in three U.S. families own a firearm, and 4.6 million children live in a home with loaded, unlocked guns.

Among children aged 17 years and younger who die by firearm suicide, 82% used guns belonging to a family member.
 

The right time for the message

Interventions to encourage safe gun storage – at a time when caregivers are really listening – can be lifesaving, Dr. Ketabchi said.

“We know that counseling is really helpful for these families, because when they come to the emergency department with a concern, they can have a teachable moment,” he said in an interview. “It resonates with them a lot more than it normally would because they have experienced something traumatic.”

The importance of safe gun storage in households with adolescents can’t be overstated, even if the children are not at risk of suicide, said Naoka Carey, a doctoral candidate at Boston College.

Ms. Carey authored an article on the prevalence of handguns among adolescents that will be published in May in Pediatrics.

“Three kinds of harm for adolescents with access to guns are accidental injury, homicide, and suicide,” she said. “Families who own guns don’t always know their teens have access to the guns.”

The problem is getting worse. Ms. Carey and colleagues found that, between 2002 and 2019, the rate of children aged 12-17 who reported carrying handguns increased 41%. Most of them were White, and their families were in high-income brackets. New data show that firearm injuries have become the leading cause of death among youth in the United States, eclipsing auto accidents for the first time.

“Preventing tragedy in your family is more than reason enough to secure guns you have,” she said.

Dr. Ketabchi disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Caregivers who brought suicidal adolescents to the emergency department reported safer gun storage practices after firearm counseling – a crucial way to cut gun deaths among children, according to researchers from Cincinnati Children’s Hospital.

In the study, which took place between June 2021 and Feb 2022, gun safety counseling and handouts were provided to 99 families of children who had come to the ED with mental health problems. A separate set of 101 families in similar situations received counseling and handouts, along with two cable-style gun locks.

Four weeks later, parents in both groups reported an increase in safe storage practices in which they locked away all guns in the household. Those offered only counseling increased safe storage by 7.2% – from 89.9% to 97.1%.

The gains were greater for families that received locks in addition to counseling. The number of those who locked away all guns rose from 82.2% to 98.5% – a 16.3% increase. (Roughly one-third of families in both arms of the study were lost to follow-up, according to the researchers, which left 68 families in each group for analysis.)

Several caregivers in each group reported that guns had been removed entirely from the home, and more than 60% in each group said they had bought additional gun locks to secure their weapons.

“The main point of our study is that just-in-time counseling is very effective in helping these families of children with mental health concerns in securing all their guns, and an emergency department visit is a great time to do that,” said Bijan Ketabchi, MD, a clinical fellow in the division of emergency medicine at Cincinnati Children’s Hospital Medical Center, who presented the findings at the Pediatric Academic Societies annual meeting.

Dr. Ketabchi said his department sees 500-700 children each month with mental health concerns, most commonly depression. The mean age of adolescent patients in the study was 14 years.

Suicide is the second-leading cause of death among children in the United States. Both pediatric suicides and firearm suicides have increased in the past 2 decades, Dr. Ketabchi said. The number of youth suicides who use guns has risen 90% since 2008. One in three U.S. families own a firearm, and 4.6 million children live in a home with loaded, unlocked guns.

Among children aged 17 years and younger who die by firearm suicide, 82% used guns belonging to a family member.
 

The right time for the message

Interventions to encourage safe gun storage – at a time when caregivers are really listening – can be lifesaving, Dr. Ketabchi said.

“We know that counseling is really helpful for these families, because when they come to the emergency department with a concern, they can have a teachable moment,” he said in an interview. “It resonates with them a lot more than it normally would because they have experienced something traumatic.”

The importance of safe gun storage in households with adolescents can’t be overstated, even if the children are not at risk of suicide, said Naoka Carey, a doctoral candidate at Boston College.

Ms. Carey authored an article on the prevalence of handguns among adolescents that will be published in May in Pediatrics.

“Three kinds of harm for adolescents with access to guns are accidental injury, homicide, and suicide,” she said. “Families who own guns don’t always know their teens have access to the guns.”

The problem is getting worse. Ms. Carey and colleagues found that, between 2002 and 2019, the rate of children aged 12-17 who reported carrying handguns increased 41%. Most of them were White, and their families were in high-income brackets. New data show that firearm injuries have become the leading cause of death among youth in the United States, eclipsing auto accidents for the first time.

“Preventing tragedy in your family is more than reason enough to secure guns you have,” she said.

Dr. Ketabchi disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Caregivers who brought suicidal adolescents to the emergency department reported safer gun storage practices after firearm counseling – a crucial way to cut gun deaths among children, according to researchers from Cincinnati Children’s Hospital.

In the study, which took place between June 2021 and Feb 2022, gun safety counseling and handouts were provided to 99 families of children who had come to the ED with mental health problems. A separate set of 101 families in similar situations received counseling and handouts, along with two cable-style gun locks.

Four weeks later, parents in both groups reported an increase in safe storage practices in which they locked away all guns in the household. Those offered only counseling increased safe storage by 7.2% – from 89.9% to 97.1%.

The gains were greater for families that received locks in addition to counseling. The number of those who locked away all guns rose from 82.2% to 98.5% – a 16.3% increase. (Roughly one-third of families in both arms of the study were lost to follow-up, according to the researchers, which left 68 families in each group for analysis.)

Several caregivers in each group reported that guns had been removed entirely from the home, and more than 60% in each group said they had bought additional gun locks to secure their weapons.

“The main point of our study is that just-in-time counseling is very effective in helping these families of children with mental health concerns in securing all their guns, and an emergency department visit is a great time to do that,” said Bijan Ketabchi, MD, a clinical fellow in the division of emergency medicine at Cincinnati Children’s Hospital Medical Center, who presented the findings at the Pediatric Academic Societies annual meeting.

Dr. Ketabchi said his department sees 500-700 children each month with mental health concerns, most commonly depression. The mean age of adolescent patients in the study was 14 years.

Suicide is the second-leading cause of death among children in the United States. Both pediatric suicides and firearm suicides have increased in the past 2 decades, Dr. Ketabchi said. The number of youth suicides who use guns has risen 90% since 2008. One in three U.S. families own a firearm, and 4.6 million children live in a home with loaded, unlocked guns.

Among children aged 17 years and younger who die by firearm suicide, 82% used guns belonging to a family member.
 

The right time for the message

Interventions to encourage safe gun storage – at a time when caregivers are really listening – can be lifesaving, Dr. Ketabchi said.

“We know that counseling is really helpful for these families, because when they come to the emergency department with a concern, they can have a teachable moment,” he said in an interview. “It resonates with them a lot more than it normally would because they have experienced something traumatic.”

The importance of safe gun storage in households with adolescents can’t be overstated, even if the children are not at risk of suicide, said Naoka Carey, a doctoral candidate at Boston College.

Ms. Carey authored an article on the prevalence of handguns among adolescents that will be published in May in Pediatrics.

“Three kinds of harm for adolescents with access to guns are accidental injury, homicide, and suicide,” she said. “Families who own guns don’t always know their teens have access to the guns.”

The problem is getting worse. Ms. Carey and colleagues found that, between 2002 and 2019, the rate of children aged 12-17 who reported carrying handguns increased 41%. Most of them were White, and their families were in high-income brackets. New data show that firearm injuries have become the leading cause of death among youth in the United States, eclipsing auto accidents for the first time.

“Preventing tragedy in your family is more than reason enough to secure guns you have,” she said.

Dr. Ketabchi disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Stem cell therapy improves motor impairment and is safe and well tolerated in patients with traumatic brain injury (TBI), results from a phase 2 trial indicate. “We proved for the first time that we can affect outcomes in moderately to severely disabled patients with TBI using stem cells,” said study investigator Peter McAllister, MD, cofounder and medical director of the New England Center for Neurology and Headache, Stamford, Conn.

“I think the potential of regenerative medicine was always out there, but we are now getting to the point where we’re living up to that potential,” said Dr. McAllister, associate professor of neurology at Yale University, New Haven, Conn.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

No effective treatment to date

TBI can lead to motor deficits and chronic disability and currently there are no effective drugs to treat these deficits.

Researchers are increasingly focused on using somatic stem cells to restore lost function. Stem cells can differentiate or proliferate into different types of cells and are thought to promote repair and regeneration of tissues or organs damaged due to illness or injury.

The study included 61 patients with TBI with an average age of 34 years (70% were male and 69% were White). The mean time from injury was 8 years and Glasgow Outcome Scale Extended (GOS-E) ranged from 3 to 6.

Forty-six participants were randomly assigned to receive the stem cell therapy and 15 a sham procedure. In the treatment group, there were three different doses of cells (2.5 x 106, 5 x 106, and 10 x 106).

The treatment involved an investigational regenerative cell medicine comprised of bone marrow-derived mesenchymal stem cells (SB623). The allogeneic cells came from a male donor.

For the 20-minute procedure, a neurosurgeon drilled a tiny hole in the skull and, guided by MRI, injected the stem cells into the area of the lesion.

Patients receiving a surgical sham procedure were brought to the operating room, anesthetized, and had a hole drilled into the head over the area of the lesion. However, the surgeon went only halfway through the skull bone.

Participants were instructed to do specific physiotherapy exercises at home every morning and afternoon for the first 6 months of the study.

The primary efficacy endpoint was change in the Fugl-Meyer Motor Scale score (FMMS). This scale is widely used for clinical assessment of motor function, including range of motion, walking, lower limb movement, and dexterity.

At 24 weeks, the change in FMMS score for SB623-treated patients (least square [LS] mean increase 8.3) compared with controls (LS increase 2.3) was significant (P = .04).

“When we looked at all the data at 6 months, the folks who got the stem cells did statistically significantly better than the group that got the sham,” and that improvement began within the first week or two, said Dr. McAllister.
 

‘A real impact’

The treatment had a real impact on people’s lives, he said. “Some who couldn’t move their arm at all were able to put a nut on a bolt or brush their teeth, and some were able to button and unbutton where they couldn’t do that before.”

One teenager who was previously completely aphasic spoke an entire sentence.

The middle dose (5 x 106) had “by far” the best outcome, said Dr. McAllister. It’s not yet known whether the improvements will be permanent, he added.

At 48 weeks, treated patients experienced improvement over controls in secondary endpoints of the Action Research Arm Test (ARAT), which assesses grasp, grip, pinch, and gross movements; Gait Velocity (walking 10 meters); and NeuroQOL, a self-report measure of ability to carry out various activities.

However, although these endpoints were all numerically better in the stem cell groups, none reached statistical significance. This is likely because of the small study size and the fact the control group improved so much, said Dr. McAllister.

The exact mechanism of stem cell therapy is unclear, but researchers believe it “establishes a milieu of growth” for cells in the brain and promotes anti-inflammatory properties, said Dr. McAllister.

By 48 weeks, all study subjects had experienced at least one adverse event, with no differences between groups and no patient withdrawing as a result of adverse events. “There was no safety signal at all related to the stem cells,” said Dr. McAllister.

A larger phase 3 study of SB623 is planned.

The treatment may be useful in other conditions. A study of stroke survivors “just barely missed statistical significance” likely for methodological reasons and an older, sicker population, but the company plans to do another study in patients who were affected by stroke, said Dr. McAllister.

In addition, there may be potential for this approach with brain hemorrhage, Parkinson’s disease, multiple sclerosis, and other brain-related disorders, he said.
 

‘Modern-day holy grail’

Reached for a comment, TBI specialist Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, said stem cell therapy is the most promising potential treatment for brain injury. “It’s the modern-day ‘holy grail.’ “

In this study, “to see a modest improvement in gait in the primary outcome is impressive,” he said.

In addition, the fact the study didn’t have any significant or severe adverse outcomes “is promising,” he added.

Studies like this “are going to help to lay the groundwork for future studies and hopefully one day result in a safe, noninvasive treatment” for Parkinson’s disease, Alzheimer’s disease, and disorders that affect the central nervous system such as spinal cord injury, Dr. Conidi said.

This therapy involves an invasive procedure requiring implantation directly into the brain, he noted. “At present, there’s no way to get stem cells to cross the blood-brain barrier.”

In addition, although motor impairment is definitely a component of TBI, it’s not as prevalent as cognitive impairment, said Dr. Conidi.

The study was supported by SanBio Co Ltd. Dr. McAllister and Dr. Conidi have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Stem cell therapy improves motor impairment and is safe and well tolerated in patients with traumatic brain injury (TBI), results from a phase 2 trial indicate. “We proved for the first time that we can affect outcomes in moderately to severely disabled patients with TBI using stem cells,” said study investigator Peter McAllister, MD, cofounder and medical director of the New England Center for Neurology and Headache, Stamford, Conn.

“I think the potential of regenerative medicine was always out there, but we are now getting to the point where we’re living up to that potential,” said Dr. McAllister, associate professor of neurology at Yale University, New Haven, Conn.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

No effective treatment to date

TBI can lead to motor deficits and chronic disability and currently there are no effective drugs to treat these deficits.

Researchers are increasingly focused on using somatic stem cells to restore lost function. Stem cells can differentiate or proliferate into different types of cells and are thought to promote repair and regeneration of tissues or organs damaged due to illness or injury.

The study included 61 patients with TBI with an average age of 34 years (70% were male and 69% were White). The mean time from injury was 8 years and Glasgow Outcome Scale Extended (GOS-E) ranged from 3 to 6.

Forty-six participants were randomly assigned to receive the stem cell therapy and 15 a sham procedure. In the treatment group, there were three different doses of cells (2.5 x 106, 5 x 106, and 10 x 106).

The treatment involved an investigational regenerative cell medicine comprised of bone marrow-derived mesenchymal stem cells (SB623). The allogeneic cells came from a male donor.

For the 20-minute procedure, a neurosurgeon drilled a tiny hole in the skull and, guided by MRI, injected the stem cells into the area of the lesion.

Patients receiving a surgical sham procedure were brought to the operating room, anesthetized, and had a hole drilled into the head over the area of the lesion. However, the surgeon went only halfway through the skull bone.

Participants were instructed to do specific physiotherapy exercises at home every morning and afternoon for the first 6 months of the study.

The primary efficacy endpoint was change in the Fugl-Meyer Motor Scale score (FMMS). This scale is widely used for clinical assessment of motor function, including range of motion, walking, lower limb movement, and dexterity.

At 24 weeks, the change in FMMS score for SB623-treated patients (least square [LS] mean increase 8.3) compared with controls (LS increase 2.3) was significant (P = .04).

“When we looked at all the data at 6 months, the folks who got the stem cells did statistically significantly better than the group that got the sham,” and that improvement began within the first week or two, said Dr. McAllister.
 

‘A real impact’

The treatment had a real impact on people’s lives, he said. “Some who couldn’t move their arm at all were able to put a nut on a bolt or brush their teeth, and some were able to button and unbutton where they couldn’t do that before.”

One teenager who was previously completely aphasic spoke an entire sentence.

The middle dose (5 x 106) had “by far” the best outcome, said Dr. McAllister. It’s not yet known whether the improvements will be permanent, he added.

At 48 weeks, treated patients experienced improvement over controls in secondary endpoints of the Action Research Arm Test (ARAT), which assesses grasp, grip, pinch, and gross movements; Gait Velocity (walking 10 meters); and NeuroQOL, a self-report measure of ability to carry out various activities.

However, although these endpoints were all numerically better in the stem cell groups, none reached statistical significance. This is likely because of the small study size and the fact the control group improved so much, said Dr. McAllister.

The exact mechanism of stem cell therapy is unclear, but researchers believe it “establishes a milieu of growth” for cells in the brain and promotes anti-inflammatory properties, said Dr. McAllister.

By 48 weeks, all study subjects had experienced at least one adverse event, with no differences between groups and no patient withdrawing as a result of adverse events. “There was no safety signal at all related to the stem cells,” said Dr. McAllister.

A larger phase 3 study of SB623 is planned.

The treatment may be useful in other conditions. A study of stroke survivors “just barely missed statistical significance” likely for methodological reasons and an older, sicker population, but the company plans to do another study in patients who were affected by stroke, said Dr. McAllister.

In addition, there may be potential for this approach with brain hemorrhage, Parkinson’s disease, multiple sclerosis, and other brain-related disorders, he said.
 

‘Modern-day holy grail’

Reached for a comment, TBI specialist Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, said stem cell therapy is the most promising potential treatment for brain injury. “It’s the modern-day ‘holy grail.’ “

In this study, “to see a modest improvement in gait in the primary outcome is impressive,” he said.

In addition, the fact the study didn’t have any significant or severe adverse outcomes “is promising,” he added.

Studies like this “are going to help to lay the groundwork for future studies and hopefully one day result in a safe, noninvasive treatment” for Parkinson’s disease, Alzheimer’s disease, and disorders that affect the central nervous system such as spinal cord injury, Dr. Conidi said.

This therapy involves an invasive procedure requiring implantation directly into the brain, he noted. “At present, there’s no way to get stem cells to cross the blood-brain barrier.”

In addition, although motor impairment is definitely a component of TBI, it’s not as prevalent as cognitive impairment, said Dr. Conidi.

The study was supported by SanBio Co Ltd. Dr. McAllister and Dr. Conidi have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Stem cell therapy improves motor impairment and is safe and well tolerated in patients with traumatic brain injury (TBI), results from a phase 2 trial indicate. “We proved for the first time that we can affect outcomes in moderately to severely disabled patients with TBI using stem cells,” said study investigator Peter McAllister, MD, cofounder and medical director of the New England Center for Neurology and Headache, Stamford, Conn.

“I think the potential of regenerative medicine was always out there, but we are now getting to the point where we’re living up to that potential,” said Dr. McAllister, associate professor of neurology at Yale University, New Haven, Conn.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

No effective treatment to date

TBI can lead to motor deficits and chronic disability and currently there are no effective drugs to treat these deficits.

Researchers are increasingly focused on using somatic stem cells to restore lost function. Stem cells can differentiate or proliferate into different types of cells and are thought to promote repair and regeneration of tissues or organs damaged due to illness or injury.

The study included 61 patients with TBI with an average age of 34 years (70% were male and 69% were White). The mean time from injury was 8 years and Glasgow Outcome Scale Extended (GOS-E) ranged from 3 to 6.

Forty-six participants were randomly assigned to receive the stem cell therapy and 15 a sham procedure. In the treatment group, there were three different doses of cells (2.5 x 106, 5 x 106, and 10 x 106).

The treatment involved an investigational regenerative cell medicine comprised of bone marrow-derived mesenchymal stem cells (SB623). The allogeneic cells came from a male donor.

For the 20-minute procedure, a neurosurgeon drilled a tiny hole in the skull and, guided by MRI, injected the stem cells into the area of the lesion.

Patients receiving a surgical sham procedure were brought to the operating room, anesthetized, and had a hole drilled into the head over the area of the lesion. However, the surgeon went only halfway through the skull bone.

Participants were instructed to do specific physiotherapy exercises at home every morning and afternoon for the first 6 months of the study.

The primary efficacy endpoint was change in the Fugl-Meyer Motor Scale score (FMMS). This scale is widely used for clinical assessment of motor function, including range of motion, walking, lower limb movement, and dexterity.

At 24 weeks, the change in FMMS score for SB623-treated patients (least square [LS] mean increase 8.3) compared with controls (LS increase 2.3) was significant (P = .04).

“When we looked at all the data at 6 months, the folks who got the stem cells did statistically significantly better than the group that got the sham,” and that improvement began within the first week or two, said Dr. McAllister.
 

‘A real impact’

The treatment had a real impact on people’s lives, he said. “Some who couldn’t move their arm at all were able to put a nut on a bolt or brush their teeth, and some were able to button and unbutton where they couldn’t do that before.”

One teenager who was previously completely aphasic spoke an entire sentence.

The middle dose (5 x 106) had “by far” the best outcome, said Dr. McAllister. It’s not yet known whether the improvements will be permanent, he added.

At 48 weeks, treated patients experienced improvement over controls in secondary endpoints of the Action Research Arm Test (ARAT), which assesses grasp, grip, pinch, and gross movements; Gait Velocity (walking 10 meters); and NeuroQOL, a self-report measure of ability to carry out various activities.

However, although these endpoints were all numerically better in the stem cell groups, none reached statistical significance. This is likely because of the small study size and the fact the control group improved so much, said Dr. McAllister.

The exact mechanism of stem cell therapy is unclear, but researchers believe it “establishes a milieu of growth” for cells in the brain and promotes anti-inflammatory properties, said Dr. McAllister.

By 48 weeks, all study subjects had experienced at least one adverse event, with no differences between groups and no patient withdrawing as a result of adverse events. “There was no safety signal at all related to the stem cells,” said Dr. McAllister.

A larger phase 3 study of SB623 is planned.

The treatment may be useful in other conditions. A study of stroke survivors “just barely missed statistical significance” likely for methodological reasons and an older, sicker population, but the company plans to do another study in patients who were affected by stroke, said Dr. McAllister.

In addition, there may be potential for this approach with brain hemorrhage, Parkinson’s disease, multiple sclerosis, and other brain-related disorders, he said.
 

‘Modern-day holy grail’

Reached for a comment, TBI specialist Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, said stem cell therapy is the most promising potential treatment for brain injury. “It’s the modern-day ‘holy grail.’ “

In this study, “to see a modest improvement in gait in the primary outcome is impressive,” he said.

In addition, the fact the study didn’t have any significant or severe adverse outcomes “is promising,” he added.

Studies like this “are going to help to lay the groundwork for future studies and hopefully one day result in a safe, noninvasive treatment” for Parkinson’s disease, Alzheimer’s disease, and disorders that affect the central nervous system such as spinal cord injury, Dr. Conidi said.

This therapy involves an invasive procedure requiring implantation directly into the brain, he noted. “At present, there’s no way to get stem cells to cross the blood-brain barrier.”

In addition, although motor impairment is definitely a component of TBI, it’s not as prevalent as cognitive impairment, said Dr. Conidi.

The study was supported by SanBio Co Ltd. Dr. McAllister and Dr. Conidi have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Key clinical point: Donor sex did not affect post-liver transplantation (LT) recurrence of hepatocellular carcinoma (HCC) and need not be considered during donor selection or organ allocation.

Major finding: After propensity score matching, the female donor (F-D) and male donor (M-D) groups showed comparable 5-year overall recurrence rates (15% vs. 14%; P = .63) and graft recurrence rates (5% vs. 5%; P = .94). Donor sex was not identified as a significant risk factor for HCC recurrence by either univariate or multivariate analysis.

Study details: This study evaluated 1118 patients with HCC who underwent LT receiving a liver graft from the F-D (n = 446) or M-D (n = 672) groups.

Disclosures: The authors did not declare any funding source or conflicts of interest.

Source: Taura K et al. No impact of donor sex on the recurrence of hepatocellular carcinoma after liver transplantation. J Hepatobiliary Pancreat Sci. 2022 (Mar 13). Doi: 10.1002/jhbp.1134

Key clinical point: Donor sex did not affect post-liver transplantation (LT) recurrence of hepatocellular carcinoma (HCC) and need not be considered during donor selection or organ allocation.

Major finding: After propensity score matching, the female donor (F-D) and male donor (M-D) groups showed comparable 5-year overall recurrence rates (15% vs. 14%; P = .63) and graft recurrence rates (5% vs. 5%; P = .94). Donor sex was not identified as a significant risk factor for HCC recurrence by either univariate or multivariate analysis.

Study details: This study evaluated 1118 patients with HCC who underwent LT receiving a liver graft from the F-D (n = 446) or M-D (n = 672) groups.

Disclosures: The authors did not declare any funding source or conflicts of interest.

Source: Taura K et al. No impact of donor sex on the recurrence of hepatocellular carcinoma after liver transplantation. J Hepatobiliary Pancreat Sci. 2022 (Mar 13). Doi: 10.1002/jhbp.1134

Key clinical point: Donor sex did not affect post-liver transplantation (LT) recurrence of hepatocellular carcinoma (HCC) and need not be considered during donor selection or organ allocation.

Major finding: After propensity score matching, the female donor (F-D) and male donor (M-D) groups showed comparable 5-year overall recurrence rates (15% vs. 14%; P = .63) and graft recurrence rates (5% vs. 5%; P = .94). Donor sex was not identified as a significant risk factor for HCC recurrence by either univariate or multivariate analysis.

Study details: This study evaluated 1118 patients with HCC who underwent LT receiving a liver graft from the F-D (n = 446) or M-D (n = 672) groups.

Disclosures: The authors did not declare any funding source or conflicts of interest.

Source: Taura K et al. No impact of donor sex on the recurrence of hepatocellular carcinoma after liver transplantation. J Hepatobiliary Pancreat Sci. 2022 (Mar 13). Doi: 10.1002/jhbp.1134