News from the FDA/CDC

The antiseizure drugs levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam, generic) and clobazam (Onfi, Sympazan, generic) can cause a rare but serious drug hypersensitivity reaction that can be life threatening if not detected and treated promptly, the Food and Drug Administration warns in an alert.

Known as drug reaction with eosinophilia and systemic symptoms (DRESS), it may start as a rash but can quickly progress and cause injury to internal organs, the need for hospitalization, and death, the FDA notes.

A search of the FDA Adverse Event Reporting System (FAERS) and the medical literature through March 2023 identified 32 serious cases of DRESS worldwide that were associated with levetiracetam.

Three cases occurred in the United States, and 29 occurred abroad. In all 32 cases, the patients were hospitalized and received medical treatment; in 2 cases, the patients died.

The median time to onset of DRESS in the levetiracetam cases was 24 days; times ranged from 7 to 170 days. The reported signs and symptoms included skin rash (n = 22), fever (n = 20), eosinophilia (n = 17), lymph node swelling (n = 9), and atypical lymphocytes (n = 4).

Twenty-two levetiracetam-associated cases of DRESS involved injury to one or more organs, including the liver, lungs, kidneys, and gallbladder.

In 25 of the 29 cases for which information on treatment discontinuation was available, DRESS symptoms resolved when levetiracetam was discontinued.

As for clobazam, a search of FAERS and the medical literature through July 2023 identified 10 serious cases of DRESS worldwide – 1 in the United States and 9 abroad. All 10 patients were hospitalized and received medical treatment. No deaths were reported.

The median time to onset of clobazam-associated DRESS was 21.5 days (range, 7-103 days). The reported signs and symptoms included skin rash (n = 10), fever (n = 8), eosinophilia (n = 7), facial swelling (n = 7), leukocytosis (n = 4), lymph node swelling (n = 4), and leukopenia/thrombocytopenia (n = 1).

In nine cases, there was injury to one or more organs, including the liver, kidneys, and gastrointestinal tract.

DRESS symptoms resolved in all 10 cases when treatment with clobazam was stopped. DRESS and other serious skin reactions reported with clobazam, a benzodiazepine, have not generally been associated with other benzodiazepines, the FDA notes.

Label updates

As a result of these cases, warnings about the risk of DRESS will be added to the prescribing information and patient medication guides for these medicines, the FDA announced.

“Health care professionals should be aware that prompt recognition and early treatment is important for improving DRESS outcomes and decreasing mortality,” the FDA said.

They noted that diagnosis is often difficult because early signs and symptoms, such as fever and swollen lymph nodes, may be present without evidence of a rash.

DRESS may develop 2-8 weeks after starting levetiracetam or clobazam. Symptoms and intensity can vary widely.

DRESS can also be confused with other serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The FDA says patients should be advised of the signs and symptoms of DRESS and be told to stop taking the medicine and seek immediate medical attention if DRESS is suspected during treatment with levetiracetam or clobazam.

Adverse reactions with these medications should be reported to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

The antiseizure drugs levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam, generic) and clobazam (Onfi, Sympazan, generic) can cause a rare but serious drug hypersensitivity reaction that can be life threatening if not detected and treated promptly, the Food and Drug Administration warns in an alert.

Known as drug reaction with eosinophilia and systemic symptoms (DRESS), it may start as a rash but can quickly progress and cause injury to internal organs, the need for hospitalization, and death, the FDA notes.

A search of the FDA Adverse Event Reporting System (FAERS) and the medical literature through March 2023 identified 32 serious cases of DRESS worldwide that were associated with levetiracetam.

Three cases occurred in the United States, and 29 occurred abroad. In all 32 cases, the patients were hospitalized and received medical treatment; in 2 cases, the patients died.

The median time to onset of DRESS in the levetiracetam cases was 24 days; times ranged from 7 to 170 days. The reported signs and symptoms included skin rash (n = 22), fever (n = 20), eosinophilia (n = 17), lymph node swelling (n = 9), and atypical lymphocytes (n = 4).

Twenty-two levetiracetam-associated cases of DRESS involved injury to one or more organs, including the liver, lungs, kidneys, and gallbladder.

In 25 of the 29 cases for which information on treatment discontinuation was available, DRESS symptoms resolved when levetiracetam was discontinued.

As for clobazam, a search of FAERS and the medical literature through July 2023 identified 10 serious cases of DRESS worldwide – 1 in the United States and 9 abroad. All 10 patients were hospitalized and received medical treatment. No deaths were reported.

The median time to onset of clobazam-associated DRESS was 21.5 days (range, 7-103 days). The reported signs and symptoms included skin rash (n = 10), fever (n = 8), eosinophilia (n = 7), facial swelling (n = 7), leukocytosis (n = 4), lymph node swelling (n = 4), and leukopenia/thrombocytopenia (n = 1).

In nine cases, there was injury to one or more organs, including the liver, kidneys, and gastrointestinal tract.

DRESS symptoms resolved in all 10 cases when treatment with clobazam was stopped. DRESS and other serious skin reactions reported with clobazam, a benzodiazepine, have not generally been associated with other benzodiazepines, the FDA notes.

Label updates

As a result of these cases, warnings about the risk of DRESS will be added to the prescribing information and patient medication guides for these medicines, the FDA announced.

“Health care professionals should be aware that prompt recognition and early treatment is important for improving DRESS outcomes and decreasing mortality,” the FDA said.

They noted that diagnosis is often difficult because early signs and symptoms, such as fever and swollen lymph nodes, may be present without evidence of a rash.

DRESS may develop 2-8 weeks after starting levetiracetam or clobazam. Symptoms and intensity can vary widely.

DRESS can also be confused with other serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The FDA says patients should be advised of the signs and symptoms of DRESS and be told to stop taking the medicine and seek immediate medical attention if DRESS is suspected during treatment with levetiracetam or clobazam.

Adverse reactions with these medications should be reported to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

The antiseizure drugs levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam, generic) and clobazam (Onfi, Sympazan, generic) can cause a rare but serious drug hypersensitivity reaction that can be life threatening if not detected and treated promptly, the Food and Drug Administration warns in an alert.

Known as drug reaction with eosinophilia and systemic symptoms (DRESS), it may start as a rash but can quickly progress and cause injury to internal organs, the need for hospitalization, and death, the FDA notes.

A search of the FDA Adverse Event Reporting System (FAERS) and the medical literature through March 2023 identified 32 serious cases of DRESS worldwide that were associated with levetiracetam.

Three cases occurred in the United States, and 29 occurred abroad. In all 32 cases, the patients were hospitalized and received medical treatment; in 2 cases, the patients died.

The median time to onset of DRESS in the levetiracetam cases was 24 days; times ranged from 7 to 170 days. The reported signs and symptoms included skin rash (n = 22), fever (n = 20), eosinophilia (n = 17), lymph node swelling (n = 9), and atypical lymphocytes (n = 4).

Twenty-two levetiracetam-associated cases of DRESS involved injury to one or more organs, including the liver, lungs, kidneys, and gallbladder.

In 25 of the 29 cases for which information on treatment discontinuation was available, DRESS symptoms resolved when levetiracetam was discontinued.

As for clobazam, a search of FAERS and the medical literature through July 2023 identified 10 serious cases of DRESS worldwide – 1 in the United States and 9 abroad. All 10 patients were hospitalized and received medical treatment. No deaths were reported.

The median time to onset of clobazam-associated DRESS was 21.5 days (range, 7-103 days). The reported signs and symptoms included skin rash (n = 10), fever (n = 8), eosinophilia (n = 7), facial swelling (n = 7), leukocytosis (n = 4), lymph node swelling (n = 4), and leukopenia/thrombocytopenia (n = 1).

In nine cases, there was injury to one or more organs, including the liver, kidneys, and gastrointestinal tract.

DRESS symptoms resolved in all 10 cases when treatment with clobazam was stopped. DRESS and other serious skin reactions reported with clobazam, a benzodiazepine, have not generally been associated with other benzodiazepines, the FDA notes.

Label updates

As a result of these cases, warnings about the risk of DRESS will be added to the prescribing information and patient medication guides for these medicines, the FDA announced.

“Health care professionals should be aware that prompt recognition and early treatment is important for improving DRESS outcomes and decreasing mortality,” the FDA said.

They noted that diagnosis is often difficult because early signs and symptoms, such as fever and swollen lymph nodes, may be present without evidence of a rash.

DRESS may develop 2-8 weeks after starting levetiracetam or clobazam. Symptoms and intensity can vary widely.

DRESS can also be confused with other serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The FDA says patients should be advised of the signs and symptoms of DRESS and be told to stop taking the medicine and seek immediate medical attention if DRESS is suspected during treatment with levetiracetam or clobazam.

Adverse reactions with these medications should be reported to the FDA’s MedWatch program.

A version of this article appeared on Medscape.com.

An emerging variant of COVID-19 called BA.2.86 that caused alarm in the summer of 2023 has landed on the Center for Disease Control and Prevention’s radar again.

The variant accounted for nearly 9% of cases during the 2-week period ending Nov. 25, up from 3% during the previous 2 weeks, according to data published Nov. 27 by the CDC. The estimates are not exact, and the CDC indicated the actual percentage of cases may range from 5% to 15%.

The CDC took the unusual step of publishing a specific statement about the rise in BA.2.86 cases. The variant drew worldwide attention during the summer because of how different its makeup is, compared with other prominent variants of the virus that causes COVID-19, raising the potential for the new variant to be more capable of causing infection. But after a flurry of interest in BA.2.86, it didn’t end up being as widespread as expected, so for months it wasn’t listed as a standalone variant on the CDC’s variant tracker list.

“At this time, BA.2.86 does not appear to be driving increases in infections or hospitalizations in the United States,” the CDC wrote in its advisory. “It is not possible at this time to know whether BA.2.86 infection produces different symptoms from other variants. In general, symptoms of COVID-19 tend to be similar across variants. The types of symptoms and how severe they are usually depend more on a person’s immunity than which variant causes the infection.”

BA.2.86 is now the third-most prominent variant circulating the United States, behind HV.1 and EG.5, which combined account for about 45% of all U.S. COVID-19 cases. All three are from the Omicron lineage of the virus.

About 8% of all COVID tests reported to the CDC were positive for the week ending Nov. 18, which is a decline, compared with recent weeks. But indicators for severe cases of the illness have ticked up lately, including rises among ED visits for COVID, hospitalizations, and deaths.

A version of this article appeared on WebMD.com.

An emerging variant of COVID-19 called BA.2.86 that caused alarm in the summer of 2023 has landed on the Center for Disease Control and Prevention’s radar again.

The variant accounted for nearly 9% of cases during the 2-week period ending Nov. 25, up from 3% during the previous 2 weeks, according to data published Nov. 27 by the CDC. The estimates are not exact, and the CDC indicated the actual percentage of cases may range from 5% to 15%.

The CDC took the unusual step of publishing a specific statement about the rise in BA.2.86 cases. The variant drew worldwide attention during the summer because of how different its makeup is, compared with other prominent variants of the virus that causes COVID-19, raising the potential for the new variant to be more capable of causing infection. But after a flurry of interest in BA.2.86, it didn’t end up being as widespread as expected, so for months it wasn’t listed as a standalone variant on the CDC’s variant tracker list.

“At this time, BA.2.86 does not appear to be driving increases in infections or hospitalizations in the United States,” the CDC wrote in its advisory. “It is not possible at this time to know whether BA.2.86 infection produces different symptoms from other variants. In general, symptoms of COVID-19 tend to be similar across variants. The types of symptoms and how severe they are usually depend more on a person’s immunity than which variant causes the infection.”

BA.2.86 is now the third-most prominent variant circulating the United States, behind HV.1 and EG.5, which combined account for about 45% of all U.S. COVID-19 cases. All three are from the Omicron lineage of the virus.

About 8% of all COVID tests reported to the CDC were positive for the week ending Nov. 18, which is a decline, compared with recent weeks. But indicators for severe cases of the illness have ticked up lately, including rises among ED visits for COVID, hospitalizations, and deaths.

A version of this article appeared on WebMD.com.

An emerging variant of COVID-19 called BA.2.86 that caused alarm in the summer of 2023 has landed on the Center for Disease Control and Prevention’s radar again.

The variant accounted for nearly 9% of cases during the 2-week period ending Nov. 25, up from 3% during the previous 2 weeks, according to data published Nov. 27 by the CDC. The estimates are not exact, and the CDC indicated the actual percentage of cases may range from 5% to 15%.

The CDC took the unusual step of publishing a specific statement about the rise in BA.2.86 cases. The variant drew worldwide attention during the summer because of how different its makeup is, compared with other prominent variants of the virus that causes COVID-19, raising the potential for the new variant to be more capable of causing infection. But after a flurry of interest in BA.2.86, it didn’t end up being as widespread as expected, so for months it wasn’t listed as a standalone variant on the CDC’s variant tracker list.

“At this time, BA.2.86 does not appear to be driving increases in infections or hospitalizations in the United States,” the CDC wrote in its advisory. “It is not possible at this time to know whether BA.2.86 infection produces different symptoms from other variants. In general, symptoms of COVID-19 tend to be similar across variants. The types of symptoms and how severe they are usually depend more on a person’s immunity than which variant causes the infection.”

BA.2.86 is now the third-most prominent variant circulating the United States, behind HV.1 and EG.5, which combined account for about 45% of all U.S. COVID-19 cases. All three are from the Omicron lineage of the virus.

About 8% of all COVID tests reported to the CDC were positive for the week ending Nov. 18, which is a decline, compared with recent weeks. But indicators for severe cases of the illness have ticked up lately, including rises among ED visits for COVID, hospitalizations, and deaths.

A version of this article appeared on WebMD.com.

The Food and Drug Administration has approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for certain previously treated adults with hormone receptor (HR)–positive, human epidermal growth factor receptor (HER2)–negative, locally advanced or metastatic breast cancer.

Specifically, the first-in-class AKT kinase inhibitor approval is for patients with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, whose metastatic disease progressed on at least one endocrine-based regimen or who experienced recurrence on or within 12 months of completing adjuvant therapy, according to the FDA approval announcement.

Olivier Le Moal/Getty Images

The FDA also approved a companion diagnostic device, the FoundationOne CDx assay, to identify patients who are eligible for treatment with capivasertib.

Approval of capivasertib was based on findings from the randomized, placebo-controlled, phase 3 CAPItello-291 trial, which involved 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, including 289 whose tumors had PIK3CA/AKT1/PTEN alterations. All had progressed on aromatase inhibitor–based treatment and may have received up to two prior lines of endocrine therapy and up to one line of chemotherapy.

Patients were randomized to either 400 mg of oral capivasertib or placebo twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Patients in both arms received 500 mg intramuscular fulvestrant on cycle 1 days 1 and 15, and then every 28 days thereafter. Treatment continued until disease progression or unacceptable toxicity.

In the 289 patients with PIK3CA/AKT1/PTEN–altered tumors, median progression-free survival (PFS) in the capivasertib arm was 7.3 months versus 3.1 months in the placebo group (hazard ratio, 0.50).

An exploratory analysis of PFS in the 313 (44%) patients whose tumors did not have a PIK3CA/AKT1/PTEN alteration demonstrated a less notable benefit to the combination (HR, 0.79; 95% confidence interval, 0.61-1.02), indicating that “the difference in the overall population was primarily attributed to the results seen in the population of patients whose tumors have PIK3CA/AKT1/PTEN alteration,” the FDA explained.

Adverse reactions occurring in at least 20% of patients included decreased lymphocytes, leukocytes, hemoglobin, and neutrophils; increased fasting glucose, creatinine, and triglycerides; and diarrhea, nausea, fatigue, vomiting, and stomatitis.

The recommended capivasertib dose is 400 mg orally twice daily, given about 12 hours apart with or without food, for 4 days followed by 3 off days until disease progression or unacceptable toxicity, according to the prescribing information.

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

The Food and Drug Administration has approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for certain previously treated adults with hormone receptor (HR)–positive, human epidermal growth factor receptor (HER2)–negative, locally advanced or metastatic breast cancer.

Specifically, the first-in-class AKT kinase inhibitor approval is for patients with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, whose metastatic disease progressed on at least one endocrine-based regimen or who experienced recurrence on or within 12 months of completing adjuvant therapy, according to the FDA approval announcement.

Olivier Le Moal/Getty Images

The FDA also approved a companion diagnostic device, the FoundationOne CDx assay, to identify patients who are eligible for treatment with capivasertib.

Approval of capivasertib was based on findings from the randomized, placebo-controlled, phase 3 CAPItello-291 trial, which involved 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, including 289 whose tumors had PIK3CA/AKT1/PTEN alterations. All had progressed on aromatase inhibitor–based treatment and may have received up to two prior lines of endocrine therapy and up to one line of chemotherapy.

Patients were randomized to either 400 mg of oral capivasertib or placebo twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Patients in both arms received 500 mg intramuscular fulvestrant on cycle 1 days 1 and 15, and then every 28 days thereafter. Treatment continued until disease progression or unacceptable toxicity.

In the 289 patients with PIK3CA/AKT1/PTEN–altered tumors, median progression-free survival (PFS) in the capivasertib arm was 7.3 months versus 3.1 months in the placebo group (hazard ratio, 0.50).

An exploratory analysis of PFS in the 313 (44%) patients whose tumors did not have a PIK3CA/AKT1/PTEN alteration demonstrated a less notable benefit to the combination (HR, 0.79; 95% confidence interval, 0.61-1.02), indicating that “the difference in the overall population was primarily attributed to the results seen in the population of patients whose tumors have PIK3CA/AKT1/PTEN alteration,” the FDA explained.

Adverse reactions occurring in at least 20% of patients included decreased lymphocytes, leukocytes, hemoglobin, and neutrophils; increased fasting glucose, creatinine, and triglycerides; and diarrhea, nausea, fatigue, vomiting, and stomatitis.

The recommended capivasertib dose is 400 mg orally twice daily, given about 12 hours apart with or without food, for 4 days followed by 3 off days until disease progression or unacceptable toxicity, according to the prescribing information.

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

The Food and Drug Administration has approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for certain previously treated adults with hormone receptor (HR)–positive, human epidermal growth factor receptor (HER2)–negative, locally advanced or metastatic breast cancer.

Specifically, the first-in-class AKT kinase inhibitor approval is for patients with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, whose metastatic disease progressed on at least one endocrine-based regimen or who experienced recurrence on or within 12 months of completing adjuvant therapy, according to the FDA approval announcement.

Olivier Le Moal/Getty Images

The FDA also approved a companion diagnostic device, the FoundationOne CDx assay, to identify patients who are eligible for treatment with capivasertib.

Approval of capivasertib was based on findings from the randomized, placebo-controlled, phase 3 CAPItello-291 trial, which involved 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, including 289 whose tumors had PIK3CA/AKT1/PTEN alterations. All had progressed on aromatase inhibitor–based treatment and may have received up to two prior lines of endocrine therapy and up to one line of chemotherapy.

Patients were randomized to either 400 mg of oral capivasertib or placebo twice daily for 4 days, followed by 3 days off treatment each week over a 28-day treatment cycle. Patients in both arms received 500 mg intramuscular fulvestrant on cycle 1 days 1 and 15, and then every 28 days thereafter. Treatment continued until disease progression or unacceptable toxicity.

In the 289 patients with PIK3CA/AKT1/PTEN–altered tumors, median progression-free survival (PFS) in the capivasertib arm was 7.3 months versus 3.1 months in the placebo group (hazard ratio, 0.50).

An exploratory analysis of PFS in the 313 (44%) patients whose tumors did not have a PIK3CA/AKT1/PTEN alteration demonstrated a less notable benefit to the combination (HR, 0.79; 95% confidence interval, 0.61-1.02), indicating that “the difference in the overall population was primarily attributed to the results seen in the population of patients whose tumors have PIK3CA/AKT1/PTEN alteration,” the FDA explained.

Adverse reactions occurring in at least 20% of patients included decreased lymphocytes, leukocytes, hemoglobin, and neutrophils; increased fasting glucose, creatinine, and triglycerides; and diarrhea, nausea, fatigue, vomiting, and stomatitis.

The recommended capivasertib dose is 400 mg orally twice daily, given about 12 hours apart with or without food, for 4 days followed by 3 off days until disease progression or unacceptable toxicity, according to the prescribing information.

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

People who want to be tested for chlamydia and gonorrhea are now able to do so without leaving their homes.

Called Simple 2, it’s the first test approved by the Food and Drug Administration that uses a sample collected at home to test for an STD, other than tests for HIV. The test can be purchased over-the-counter in stores or ordered online and delivered in discreet packaging. A vaginal swab or urine sample is collected and then sent for laboratory testing using a prepaid shipping label.

The FDA issued the final needed approval on Nov. 15, and the product is already for sale on the website of the manufacturer, LetsGetChecked. The listed price is $99 with free shipping for a single test kit, and the site offers a discounted subscription to receive a kit every 3 months for $69.30 per kit.

Gonorrhea cases have surged 28% since 2017, reaching 700,000 cases during 2021, Centers for Disease Control and Prevention data show. Chlamydia has also been on the rise, up 4% from 2020 to 2021, with 1.6 million annual infections.

Previously, tests for the two STDs required that samples be taken at a health care location such as a doctor’s office. The Simple 2 test results can be retrieved online, and a health care provider will reach out to people whose tests are positive or invalid. Results are typically received in 2-5 days, according to a press release from LetsGetChecked, which also offers treatment services.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a statement. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”

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

People who want to be tested for chlamydia and gonorrhea are now able to do so without leaving their homes.

Called Simple 2, it’s the first test approved by the Food and Drug Administration that uses a sample collected at home to test for an STD, other than tests for HIV. The test can be purchased over-the-counter in stores or ordered online and delivered in discreet packaging. A vaginal swab or urine sample is collected and then sent for laboratory testing using a prepaid shipping label.

The FDA issued the final needed approval on Nov. 15, and the product is already for sale on the website of the manufacturer, LetsGetChecked. The listed price is $99 with free shipping for a single test kit, and the site offers a discounted subscription to receive a kit every 3 months for $69.30 per kit.

Gonorrhea cases have surged 28% since 2017, reaching 700,000 cases during 2021, Centers for Disease Control and Prevention data show. Chlamydia has also been on the rise, up 4% from 2020 to 2021, with 1.6 million annual infections.

Previously, tests for the two STDs required that samples be taken at a health care location such as a doctor’s office. The Simple 2 test results can be retrieved online, and a health care provider will reach out to people whose tests are positive or invalid. Results are typically received in 2-5 days, according to a press release from LetsGetChecked, which also offers treatment services.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a statement. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”

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

People who want to be tested for chlamydia and gonorrhea are now able to do so without leaving their homes.

Called Simple 2, it’s the first test approved by the Food and Drug Administration that uses a sample collected at home to test for an STD, other than tests for HIV. The test can be purchased over-the-counter in stores or ordered online and delivered in discreet packaging. A vaginal swab or urine sample is collected and then sent for laboratory testing using a prepaid shipping label.

The FDA issued the final needed approval on Nov. 15, and the product is already for sale on the website of the manufacturer, LetsGetChecked. The listed price is $99 with free shipping for a single test kit, and the site offers a discounted subscription to receive a kit every 3 months for $69.30 per kit.

Gonorrhea cases have surged 28% since 2017, reaching 700,000 cases during 2021, Centers for Disease Control and Prevention data show. Chlamydia has also been on the rise, up 4% from 2020 to 2021, with 1.6 million annual infections.

Previously, tests for the two STDs required that samples be taken at a health care location such as a doctor’s office. The Simple 2 test results can be retrieved online, and a health care provider will reach out to people whose tests are positive or invalid. Results are typically received in 2-5 days, according to a press release from LetsGetChecked, which also offers treatment services.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a statement. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”

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

The Centers for Disease Control and Prevention said 3% of children starting kindergarten in the 2022-2023 school year received an exemption from one of the four key vaccines – the highest exemption rate ever reported in the United States.

Of the 3% of children who got exemptions, 0.2% were for medical reasons and 2.8% for nonmedical reasons, the CDC report said. The overall exemption rate was 2.6% for the previous school year. 

Though more children received exemptions, the overall national vaccination rate remained steady at 93% for children entering kindergarten for the 2022-2023 school year. Before the COVID-19 pandemic, the overall rate was 95%, the CDC said.

“The bad news is that it’s gone down since the pandemic and still hasn’t rebounded,” Sean O’Leary, MD, a University of Colorado pediatric infectious diseases specialist, told The Associated Press. “The good news is that the vast majority of parents are still vaccinating their kids according to the recommended schedule.”

The CDC report did not offer a specific reason for higher vaccine exemptions. But it did note that the increase could be caused by the COVID-19 pandemic and COVID vaccine hesitancy. 

“There is a rising distrust in the health care system,” Amna Husain, MD, a pediatrician in private practice in North Carolina and a spokesperson for the American Academy of Pediatrics, told NBC News. Vaccine exemptions “have unfortunately trended upward with it.”

Exemption rates varied across the nation. The CDC said 40 states reported a rise in exemptions and that the exemption rate went over 5% in 10 states: Alaska, Arizona, Hawaii, Idaho, Michigan, Nevada, North Dakota, Oregon, Utah, and Wisconsin. Idaho had the highest exemption rate in 2022 with 12%.

While requirements vary from state to state, most states require students entering kindergarten to receive four vaccines: MMR, DTaP, polio, and chickenpox.

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

The Centers for Disease Control and Prevention said 3% of children starting kindergarten in the 2022-2023 school year received an exemption from one of the four key vaccines – the highest exemption rate ever reported in the United States.

Of the 3% of children who got exemptions, 0.2% were for medical reasons and 2.8% for nonmedical reasons, the CDC report said. The overall exemption rate was 2.6% for the previous school year. 

Though more children received exemptions, the overall national vaccination rate remained steady at 93% for children entering kindergarten for the 2022-2023 school year. Before the COVID-19 pandemic, the overall rate was 95%, the CDC said.

“The bad news is that it’s gone down since the pandemic and still hasn’t rebounded,” Sean O’Leary, MD, a University of Colorado pediatric infectious diseases specialist, told The Associated Press. “The good news is that the vast majority of parents are still vaccinating their kids according to the recommended schedule.”

The CDC report did not offer a specific reason for higher vaccine exemptions. But it did note that the increase could be caused by the COVID-19 pandemic and COVID vaccine hesitancy. 

“There is a rising distrust in the health care system,” Amna Husain, MD, a pediatrician in private practice in North Carolina and a spokesperson for the American Academy of Pediatrics, told NBC News. Vaccine exemptions “have unfortunately trended upward with it.”

Exemption rates varied across the nation. The CDC said 40 states reported a rise in exemptions and that the exemption rate went over 5% in 10 states: Alaska, Arizona, Hawaii, Idaho, Michigan, Nevada, North Dakota, Oregon, Utah, and Wisconsin. Idaho had the highest exemption rate in 2022 with 12%.

While requirements vary from state to state, most states require students entering kindergarten to receive four vaccines: MMR, DTaP, polio, and chickenpox.

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

The Centers for Disease Control and Prevention said 3% of children starting kindergarten in the 2022-2023 school year received an exemption from one of the four key vaccines – the highest exemption rate ever reported in the United States.

Of the 3% of children who got exemptions, 0.2% were for medical reasons and 2.8% for nonmedical reasons, the CDC report said. The overall exemption rate was 2.6% for the previous school year. 

Though more children received exemptions, the overall national vaccination rate remained steady at 93% for children entering kindergarten for the 2022-2023 school year. Before the COVID-19 pandemic, the overall rate was 95%, the CDC said.

“The bad news is that it’s gone down since the pandemic and still hasn’t rebounded,” Sean O’Leary, MD, a University of Colorado pediatric infectious diseases specialist, told The Associated Press. “The good news is that the vast majority of parents are still vaccinating their kids according to the recommended schedule.”

The CDC report did not offer a specific reason for higher vaccine exemptions. But it did note that the increase could be caused by the COVID-19 pandemic and COVID vaccine hesitancy. 

“There is a rising distrust in the health care system,” Amna Husain, MD, a pediatrician in private practice in North Carolina and a spokesperson for the American Academy of Pediatrics, told NBC News. Vaccine exemptions “have unfortunately trended upward with it.”

Exemption rates varied across the nation. The CDC said 40 states reported a rise in exemptions and that the exemption rate went over 5% in 10 states: Alaska, Arizona, Hawaii, Idaho, Michigan, Nevada, North Dakota, Oregon, Utah, and Wisconsin. Idaho had the highest exemption rate in 2022 with 12%.

While requirements vary from state to state, most states require students entering kindergarten to receive four vaccines: MMR, DTaP, polio, and chickenpox.

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

Infant mortality rates rose in 2022 for the first time in more than 20 years, according to a new government report.

The overall mortality rate and the rate for neonatal infants, those younger than 28 days old, rose by 3% from 2021 to 2022, says the Centers for Disease Control and Prevention’s National Center for Health Statistics. The mortality rate for infants older than 28 days rose by 4%.

Meanwhile, infant deaths caused by maternal complications rose by 8% and those caused by bacterial sepsis rose by 14%, the report says.

“We live in a country with significant resources, so the infant mortality rate and the increase are shockingly high,” wrote Sandy Chung, MD, of the American Academy of Pediatrics, to CNN. “As pediatricians who help children grow into healthy adults, any death of any child is one too many. The infant mortality rate in this country in unacceptable.”

Experts say the increase could be a sign of an underlying health care issue, an unusual occurrence, or partly related to the COVID-19 pandemic.

The infant mortality rate rose among mothers aged 25-29 years; for preterm babies; for boys; and in Georgia, Iowa, Missouri, and Texas. The rate declined in Nevada.

“Mortality rates increased significantly among infants of American Indian and Alaska Native non-Hispanic ... and White non-Hispanic women,” the report says.

“Mortality rates for infants of Black women did not increase by much, the report found, but Black infants experienced the highest overall rates of infant mortality: nearly 11 deaths per 1,000 births, or over double the mortality rate of White infants,” CNN wrote.

“We know that for people who live in or near poverty and for certain racial and ethnic groups there are significant challenges with getting access to a doctor or getting treatments,” Dr. Chung wrote. “This can lead to moms and babies showing up for care when they are sicker and more likely have serious outcomes, even death.”

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

Infant mortality rates rose in 2022 for the first time in more than 20 years, according to a new government report.

The overall mortality rate and the rate for neonatal infants, those younger than 28 days old, rose by 3% from 2021 to 2022, says the Centers for Disease Control and Prevention’s National Center for Health Statistics. The mortality rate for infants older than 28 days rose by 4%.

Meanwhile, infant deaths caused by maternal complications rose by 8% and those caused by bacterial sepsis rose by 14%, the report says.

“We live in a country with significant resources, so the infant mortality rate and the increase are shockingly high,” wrote Sandy Chung, MD, of the American Academy of Pediatrics, to CNN. “As pediatricians who help children grow into healthy adults, any death of any child is one too many. The infant mortality rate in this country in unacceptable.”

Experts say the increase could be a sign of an underlying health care issue, an unusual occurrence, or partly related to the COVID-19 pandemic.

The infant mortality rate rose among mothers aged 25-29 years; for preterm babies; for boys; and in Georgia, Iowa, Missouri, and Texas. The rate declined in Nevada.

“Mortality rates increased significantly among infants of American Indian and Alaska Native non-Hispanic ... and White non-Hispanic women,” the report says.

“Mortality rates for infants of Black women did not increase by much, the report found, but Black infants experienced the highest overall rates of infant mortality: nearly 11 deaths per 1,000 births, or over double the mortality rate of White infants,” CNN wrote.

“We know that for people who live in or near poverty and for certain racial and ethnic groups there are significant challenges with getting access to a doctor or getting treatments,” Dr. Chung wrote. “This can lead to moms and babies showing up for care when they are sicker and more likely have serious outcomes, even death.”

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

Infant mortality rates rose in 2022 for the first time in more than 20 years, according to a new government report.

The overall mortality rate and the rate for neonatal infants, those younger than 28 days old, rose by 3% from 2021 to 2022, says the Centers for Disease Control and Prevention’s National Center for Health Statistics. The mortality rate for infants older than 28 days rose by 4%.

Meanwhile, infant deaths caused by maternal complications rose by 8% and those caused by bacterial sepsis rose by 14%, the report says.

“We live in a country with significant resources, so the infant mortality rate and the increase are shockingly high,” wrote Sandy Chung, MD, of the American Academy of Pediatrics, to CNN. “As pediatricians who help children grow into healthy adults, any death of any child is one too many. The infant mortality rate in this country in unacceptable.”

Experts say the increase could be a sign of an underlying health care issue, an unusual occurrence, or partly related to the COVID-19 pandemic.

The infant mortality rate rose among mothers aged 25-29 years; for preterm babies; for boys; and in Georgia, Iowa, Missouri, and Texas. The rate declined in Nevada.

“Mortality rates increased significantly among infants of American Indian and Alaska Native non-Hispanic ... and White non-Hispanic women,” the report says.

“Mortality rates for infants of Black women did not increase by much, the report found, but Black infants experienced the highest overall rates of infant mortality: nearly 11 deaths per 1,000 births, or over double the mortality rate of White infants,” CNN wrote.

“We know that for people who live in or near poverty and for certain racial and ethnic groups there are significant challenges with getting access to a doctor or getting treatments,” Dr. Chung wrote. “This can lead to moms and babies showing up for care when they are sicker and more likely have serious outcomes, even death.”

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

The Food and Drug Administration has approved the Paradise Ultrasound Renal Denervation system for the treatment of hypertension, Recor Medical and parent company Otsuka Medical Devices have announced.
 

Approval follows a positive review by the FDA’s Circulatory Systems Device panel in August that deemed the system both safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications. 

Olivier Le Moal/Getty Images

Data supporting approval were provided by the RADIANCE program, the pivotal RADIANCE II trial, as well as RADIANCE-HTN SOLO and RADIANCE-HTN TRIO. RADIANCE II and RADIANCE-HTN SOLO studied patients with mild to moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO enrolled patients with resistant hypertension on standardized triple antihypertensive therapy.  

Renal denervation is intended as an adjunctive treatment option when lifestyle changes and medication have not resulted in adequate blood pressure control, the statement notes. It works by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.

The system delivers two to three doses of 360-degree ultrasound energy, lasting 7 seconds each, through each of the main renal arteries to the surrounding nerves. This particular system is water-cooled to protect the renal artery wall, the statement adds.

“Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” site principal investigator Naomi Fisher, MD, associate professor of medicine, Harvard Medical School, and director of hypertension service and hypertension innovation, division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, said in the statement.

Ultrasound renal denervation “has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure,” Dr. Fisher added.

The Paradise ultrasound renal denervation system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan, the companies note.

A second renal denervation system, the Symplicity Spyral Renal Denervation System (Medtronic) underwent FDA panel review the day after the Paradise system review in August, and although the panel voted unanimously that the Symplicity system is safe, they were split on whether or not it was efficacious. A final decision on approval by the FDA of that system is still pending.

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

The Food and Drug Administration has approved the Paradise Ultrasound Renal Denervation system for the treatment of hypertension, Recor Medical and parent company Otsuka Medical Devices have announced.
 

Approval follows a positive review by the FDA’s Circulatory Systems Device panel in August that deemed the system both safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications. 

Olivier Le Moal/Getty Images

Data supporting approval were provided by the RADIANCE program, the pivotal RADIANCE II trial, as well as RADIANCE-HTN SOLO and RADIANCE-HTN TRIO. RADIANCE II and RADIANCE-HTN SOLO studied patients with mild to moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO enrolled patients with resistant hypertension on standardized triple antihypertensive therapy.  

Renal denervation is intended as an adjunctive treatment option when lifestyle changes and medication have not resulted in adequate blood pressure control, the statement notes. It works by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.

The system delivers two to three doses of 360-degree ultrasound energy, lasting 7 seconds each, through each of the main renal arteries to the surrounding nerves. This particular system is water-cooled to protect the renal artery wall, the statement adds.

“Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” site principal investigator Naomi Fisher, MD, associate professor of medicine, Harvard Medical School, and director of hypertension service and hypertension innovation, division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, said in the statement.

Ultrasound renal denervation “has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure,” Dr. Fisher added.

The Paradise ultrasound renal denervation system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan, the companies note.

A second renal denervation system, the Symplicity Spyral Renal Denervation System (Medtronic) underwent FDA panel review the day after the Paradise system review in August, and although the panel voted unanimously that the Symplicity system is safe, they were split on whether or not it was efficacious. A final decision on approval by the FDA of that system is still pending.

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

The Food and Drug Administration has approved the Paradise Ultrasound Renal Denervation system for the treatment of hypertension, Recor Medical and parent company Otsuka Medical Devices have announced.
 

Approval follows a positive review by the FDA’s Circulatory Systems Device panel in August that deemed the system both safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications. 

Olivier Le Moal/Getty Images

Data supporting approval were provided by the RADIANCE program, the pivotal RADIANCE II trial, as well as RADIANCE-HTN SOLO and RADIANCE-HTN TRIO. RADIANCE II and RADIANCE-HTN SOLO studied patients with mild to moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO enrolled patients with resistant hypertension on standardized triple antihypertensive therapy.  

Renal denervation is intended as an adjunctive treatment option when lifestyle changes and medication have not resulted in adequate blood pressure control, the statement notes. It works by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.

The system delivers two to three doses of 360-degree ultrasound energy, lasting 7 seconds each, through each of the main renal arteries to the surrounding nerves. This particular system is water-cooled to protect the renal artery wall, the statement adds.

“Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” site principal investigator Naomi Fisher, MD, associate professor of medicine, Harvard Medical School, and director of hypertension service and hypertension innovation, division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, said in the statement.

Ultrasound renal denervation “has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure,” Dr. Fisher added.

The Paradise ultrasound renal denervation system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan, the companies note.

A second renal denervation system, the Symplicity Spyral Renal Denervation System (Medtronic) underwent FDA panel review the day after the Paradise system review in August, and although the panel voted unanimously that the Symplicity system is safe, they were split on whether or not it was efficacious. A final decision on approval by the FDA of that system is still pending.

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

The Food and Drug Administration has approved tirzepatide for chronic weight management in adults with obesity or overweight.

Eli Lilly will market tirzepatide injections for weight management under the trade name Zepbound. It was approved in May 2022 for treating type 2 diabetes. The new indication is for adults with either obesity, defined as a body mass index of 30 kg/m² or greater, or overweight, with a BMI of 27 or greater with at least one weight-related comorbidity, including hypertension, type 2 diabetes, or dyslipidemia.

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, such as heart disease, stroke, and diabetes,” said John Sharretts, MD, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

A once-weekly injection, tirzepatide reduces appetite by activating two gut hormones, glucagonlike peptide–1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The dosage is increased over 4-20 weeks to achieve a weekly dose target of 5 mg, 10 mg, or 15 mg maximum.

Efficacy was established in two pivotal randomized, double-blind, placebo-controlled trials of adults with obesity or overweight plus another condition. One trial measured weight reduction after 72 weeks in a total of 2,519 patients without diabetes who received either 5 mg, 10 mg or 15 mg of tirzepatide once weekly. Those who received the 15-mg dose achieved on average 18% of their initial body weight, compared with placebo.

The other pivotal trial enrolled a total of 938 patients with type 2 diabetes. These patients achieved an average weight loss of 12% with once-weekly tirzepatide compared to placebo.

Another trial, which was presented at the 2023 Obesity Week meeting and was published in Nature Medicine, showed clinically meaningful added weight loss for adults with obesity who did not have diabetes and who had already experienced weight loss of at least 5% after a 12-week intensive lifestyle intervention.

Another trial, which was reported at the 2023 annual meeting of the European Association for the Study of Diabetes, found that tirzepatide continued to produce “highly significant weight loss” when the drug was continued in a 1-year follow-up trial. Those who discontinued taking the drug regained some weight but not all.

Tirzepatide can cause gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and abdominal pain or discomfort. Site reactions, hypersensitivity, hair loss, burping, and gastrointestinal reflux disease have also been reported.

The medication should not be used by patients with a personal or family history of medullary thyroid cancer or by patients with multiple endocrine neoplasia syndrome type 2. It should also not be used in combination with Mounjaro or another GLP-1 receptor agonist. The safety and effectiveness of the coadministration of tirzepatide with other medications for weight management have not been established.

Zepbound should go to market in the United States by the end of 2023, with an anticipated monthly list price of $1,060, according to a news release from Eli Lilly.

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

The Food and Drug Administration has approved tirzepatide for chronic weight management in adults with obesity or overweight.

Eli Lilly will market tirzepatide injections for weight management under the trade name Zepbound. It was approved in May 2022 for treating type 2 diabetes. The new indication is for adults with either obesity, defined as a body mass index of 30 kg/m² or greater, or overweight, with a BMI of 27 or greater with at least one weight-related comorbidity, including hypertension, type 2 diabetes, or dyslipidemia.

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, such as heart disease, stroke, and diabetes,” said John Sharretts, MD, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

A once-weekly injection, tirzepatide reduces appetite by activating two gut hormones, glucagonlike peptide–1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The dosage is increased over 4-20 weeks to achieve a weekly dose target of 5 mg, 10 mg, or 15 mg maximum.

Efficacy was established in two pivotal randomized, double-blind, placebo-controlled trials of adults with obesity or overweight plus another condition. One trial measured weight reduction after 72 weeks in a total of 2,519 patients without diabetes who received either 5 mg, 10 mg or 15 mg of tirzepatide once weekly. Those who received the 15-mg dose achieved on average 18% of their initial body weight, compared with placebo.

The other pivotal trial enrolled a total of 938 patients with type 2 diabetes. These patients achieved an average weight loss of 12% with once-weekly tirzepatide compared to placebo.

Another trial, which was presented at the 2023 Obesity Week meeting and was published in Nature Medicine, showed clinically meaningful added weight loss for adults with obesity who did not have diabetes and who had already experienced weight loss of at least 5% after a 12-week intensive lifestyle intervention.

Another trial, which was reported at the 2023 annual meeting of the European Association for the Study of Diabetes, found that tirzepatide continued to produce “highly significant weight loss” when the drug was continued in a 1-year follow-up trial. Those who discontinued taking the drug regained some weight but not all.

Tirzepatide can cause gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and abdominal pain or discomfort. Site reactions, hypersensitivity, hair loss, burping, and gastrointestinal reflux disease have also been reported.

The medication should not be used by patients with a personal or family history of medullary thyroid cancer or by patients with multiple endocrine neoplasia syndrome type 2. It should also not be used in combination with Mounjaro or another GLP-1 receptor agonist. The safety and effectiveness of the coadministration of tirzepatide with other medications for weight management have not been established.

Zepbound should go to market in the United States by the end of 2023, with an anticipated monthly list price of $1,060, according to a news release from Eli Lilly.

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

The Food and Drug Administration has approved tirzepatide for chronic weight management in adults with obesity or overweight.

Eli Lilly will market tirzepatide injections for weight management under the trade name Zepbound. It was approved in May 2022 for treating type 2 diabetes. The new indication is for adults with either obesity, defined as a body mass index of 30 kg/m² or greater, or overweight, with a BMI of 27 or greater with at least one weight-related comorbidity, including hypertension, type 2 diabetes, or dyslipidemia.

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, such as heart disease, stroke, and diabetes,” said John Sharretts, MD, director of the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

A once-weekly injection, tirzepatide reduces appetite by activating two gut hormones, glucagonlike peptide–1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). The dosage is increased over 4-20 weeks to achieve a weekly dose target of 5 mg, 10 mg, or 15 mg maximum.

Efficacy was established in two pivotal randomized, double-blind, placebo-controlled trials of adults with obesity or overweight plus another condition. One trial measured weight reduction after 72 weeks in a total of 2,519 patients without diabetes who received either 5 mg, 10 mg or 15 mg of tirzepatide once weekly. Those who received the 15-mg dose achieved on average 18% of their initial body weight, compared with placebo.

The other pivotal trial enrolled a total of 938 patients with type 2 diabetes. These patients achieved an average weight loss of 12% with once-weekly tirzepatide compared to placebo.

Another trial, which was presented at the 2023 Obesity Week meeting and was published in Nature Medicine, showed clinically meaningful added weight loss for adults with obesity who did not have diabetes and who had already experienced weight loss of at least 5% after a 12-week intensive lifestyle intervention.

Another trial, which was reported at the 2023 annual meeting of the European Association for the Study of Diabetes, found that tirzepatide continued to produce “highly significant weight loss” when the drug was continued in a 1-year follow-up trial. Those who discontinued taking the drug regained some weight but not all.

Tirzepatide can cause gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and abdominal pain or discomfort. Site reactions, hypersensitivity, hair loss, burping, and gastrointestinal reflux disease have also been reported.

The medication should not be used by patients with a personal or family history of medullary thyroid cancer or by patients with multiple endocrine neoplasia syndrome type 2. It should also not be used in combination with Mounjaro or another GLP-1 receptor agonist. The safety and effectiveness of the coadministration of tirzepatide with other medications for weight management have not been established.

Zepbound should go to market in the United States by the end of 2023, with an anticipated monthly list price of $1,060, according to a news release from Eli Lilly.

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

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

All infants and children perinatally exposed to the hepatitis C virus (HCV) should be tested and, if necessary, treated, according to new guidance from the Centers for Disease Control and Prevention.

In utero–exposed infants should be tested at 2-6 months of life, much earlier than the current strategy of testing at 18 months.

HCV infection, which can lead to liver fibrosis and cirrhosis, liver failure, hepatic cancer, and transplant, will develop in 6%-7% of all perinatally exposed infants and children. Curative therapy with direct-acting antivirals can be administered starting at age 3, the CDC noted in Morbidity and Mortality Week Report (MMWR).

About 70% of children 18 months and older are not being tested with the current strategy of anti-HCV testing.

This current MMWR report supplements the 2020 CDC recommendations for adult HCV screening, which includes universal screening among pregnant persons during each pregnancy.
 

The new recommendations

• Perinatally exposed infants should receive a nucleic acid amplification test for HCV RNA at 2-6 months of age to identify those who might develop chronic HCV infection if not treated.
• Those with detectable HCV RNA should be managed in consultation with an expert in pediatric HCV.
• Infants with undetectable HCV RNA do not require further follow-up unless clinically warranted.

“Testing perinatally exposed infants beginning at age 2 months with a NAT for HCV RNA is cost-effective and allows for earlier linkage to care, appropriate evaluation, and the opportunity to provide curative, life-saving therapy,” the MMWR report said.
 

A growing problem

The CDC noted that rates of HCV infections during pregnancy are on the rise, corresponding with the ongoing opioid crisis and intravenous drug use.

Yet most perinatally exposed children are not tested for HCV infection and are not referred for hepatitis C care. Reasons might include lack of awareness of perinatal exposure by pediatric providers, lack of regular pediatric care among exposed children, and switching of health care providers before the former recommended testing age of 18 months.

The CDC’s testing recommendation is welcome news to Dawnette A. Lewis, MD, a maternal fetal medicine specialist at Northwell Health in New Hyde Park, N.Y. “As opposed to data for hep B and HIV, we have traditionally had little information and experience regarding the transmission and impact of hep C in pregnant women and their babies. We’ve been having that conversation about the lack of information for some time, and now there’s an opportunity to get evolving data on hep C and how it affects the baby, ” she said.

Northwell Health

Northwestern Medicine

Northwestern Medicine

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

• The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
• The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
• The overall response rate was 30.5%.
• “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
• The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

• The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
• From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
• Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
• Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

• The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
• The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
• The overall response rate was 30.5%.
• “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
• The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

• The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
• From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
• Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
• Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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

TOPLINE:

Use of e-cigarettes among U.S. teens was down sharply, dropping from 14.1% in 2022 to 10% in 2023, government figures show, but the majority of these youth still used flavored products, which have been shown to both entice teens and keep them vaping.

METHODOLOGY:

• The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
• The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
• The overall response rate was 30.5%.
• “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
• The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.

TAKEAWAY:

• The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
• From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
• Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
• Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.

IN PRACTICE:

“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.

SOURCE:

The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.

LIMITATIONS:

Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.

DISCLOSURES:

No potential conflicts of interest were disclosed.

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