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Active-Duty Suicide Rates Remain High
Suicides among active-duty military service members for the first 3 quarters of 2014 were consistent with numbers from 2013, according to the Department of Defense Quarterly Suicide Report Calendar Year 2014 Third Quarter (QSR), released on March 9, 2015.
From January to September 2014, 200 active-duty service members committed suicide, just 1 more than did during the same period in 2013. Data are not yet available regarding the fourth quarter of 2014.
Related: Clay Hunt Suicide Prevention Bill Signed by President Obama
There were 254 total suicides for active-duty service members in 2013, including fourth quarter data.
The DoD releases the QSR 4 times per year to “communicate the department's suicide data on a routine basis,” according to a DoD press release.
In addition to measuring rates among active-duty service members (which includes those in the military academies), the QSR also measures suicides among selected reserves and National Guard members. Data for military retirees and for service members on temporary or permanent disability are not included in the QSR because of potential overlap with VA data.
Related: Jonathan Woodson on Military Health Readiness
In 2014, during the first 3 quarters, 58 reserve members and 68 National Guard members committed suicide. The total combined number of suicide-related deaths among all military branches surveyed in the report was 326.
Although suicide numbers did not decline in 2014, some military branches are taking steps to reduce suicides in 2015.
On February 11, the U.S. Air Force changed the annual suicide prevention training for active-duty and Reserve airmen from a computer-based course to in-person training. The goal is to have all airmen receive training face-to-face by the end of 2015.
“The desired outcome is to provide airmen an opportunity to discuss suicide prevention concepts,” said Lt Col Mitzi Thomas-Lawson, Mental Health Branch chief for Air Education and Training Command.
Tech Sgt Katrina Rollins recently attended the face-to-face training and found the change from a computer-based system beneficial.
“Being part of a group discussion, seeing how everyone perceives the issues and having the facilitator bring up more discussion really changes the training for the better,” Tech Sgt Rollins said.
Suicides among active-duty military service members for the first 3 quarters of 2014 were consistent with numbers from 2013, according to the Department of Defense Quarterly Suicide Report Calendar Year 2014 Third Quarter (QSR), released on March 9, 2015.
From January to September 2014, 200 active-duty service members committed suicide, just 1 more than did during the same period in 2013. Data are not yet available regarding the fourth quarter of 2014.
Related: Clay Hunt Suicide Prevention Bill Signed by President Obama
There were 254 total suicides for active-duty service members in 2013, including fourth quarter data.
The DoD releases the QSR 4 times per year to “communicate the department's suicide data on a routine basis,” according to a DoD press release.
In addition to measuring rates among active-duty service members (which includes those in the military academies), the QSR also measures suicides among selected reserves and National Guard members. Data for military retirees and for service members on temporary or permanent disability are not included in the QSR because of potential overlap with VA data.
Related: Jonathan Woodson on Military Health Readiness
In 2014, during the first 3 quarters, 58 reserve members and 68 National Guard members committed suicide. The total combined number of suicide-related deaths among all military branches surveyed in the report was 326.
Although suicide numbers did not decline in 2014, some military branches are taking steps to reduce suicides in 2015.
On February 11, the U.S. Air Force changed the annual suicide prevention training for active-duty and Reserve airmen from a computer-based course to in-person training. The goal is to have all airmen receive training face-to-face by the end of 2015.
“The desired outcome is to provide airmen an opportunity to discuss suicide prevention concepts,” said Lt Col Mitzi Thomas-Lawson, Mental Health Branch chief for Air Education and Training Command.
Tech Sgt Katrina Rollins recently attended the face-to-face training and found the change from a computer-based system beneficial.
“Being part of a group discussion, seeing how everyone perceives the issues and having the facilitator bring up more discussion really changes the training for the better,” Tech Sgt Rollins said.
Suicides among active-duty military service members for the first 3 quarters of 2014 were consistent with numbers from 2013, according to the Department of Defense Quarterly Suicide Report Calendar Year 2014 Third Quarter (QSR), released on March 9, 2015.
From January to September 2014, 200 active-duty service members committed suicide, just 1 more than did during the same period in 2013. Data are not yet available regarding the fourth quarter of 2014.
Related: Clay Hunt Suicide Prevention Bill Signed by President Obama
There were 254 total suicides for active-duty service members in 2013, including fourth quarter data.
The DoD releases the QSR 4 times per year to “communicate the department's suicide data on a routine basis,” according to a DoD press release.
In addition to measuring rates among active-duty service members (which includes those in the military academies), the QSR also measures suicides among selected reserves and National Guard members. Data for military retirees and for service members on temporary or permanent disability are not included in the QSR because of potential overlap with VA data.
Related: Jonathan Woodson on Military Health Readiness
In 2014, during the first 3 quarters, 58 reserve members and 68 National Guard members committed suicide. The total combined number of suicide-related deaths among all military branches surveyed in the report was 326.
Although suicide numbers did not decline in 2014, some military branches are taking steps to reduce suicides in 2015.
On February 11, the U.S. Air Force changed the annual suicide prevention training for active-duty and Reserve airmen from a computer-based course to in-person training. The goal is to have all airmen receive training face-to-face by the end of 2015.
“The desired outcome is to provide airmen an opportunity to discuss suicide prevention concepts,” said Lt Col Mitzi Thomas-Lawson, Mental Health Branch chief for Air Education and Training Command.
Tech Sgt Katrina Rollins recently attended the face-to-face training and found the change from a computer-based system beneficial.
“Being part of a group discussion, seeing how everyone perceives the issues and having the facilitator bring up more discussion really changes the training for the better,” Tech Sgt Rollins said.
FDA announces new potential side effects for varenicline
The Food and Drug Administration is warning physicians and patients that taking varenicline for smoking cessation can change a patient’s reaction to alcohol and can cause seizures* in patients without prior history.
Some patients who have drunk alcohol while taking varenicline, marketed as Chantix, have reported decreased tolerance to alcohol, including symptoms such as increased drunkenness, unusual or aggressive behavior, or memory loss. Patients have also reported incidence of seizure within a month of starting varenicline, despite having no previous history of seizure.
“Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately,” the FDA recommended.
Find the full announcement on the FDA website.
*Correction, 3/11/2015: An earlier version of this article misstated one of the side effects of varenicline.
The Food and Drug Administration is warning physicians and patients that taking varenicline for smoking cessation can change a patient’s reaction to alcohol and can cause seizures* in patients without prior history.
Some patients who have drunk alcohol while taking varenicline, marketed as Chantix, have reported decreased tolerance to alcohol, including symptoms such as increased drunkenness, unusual or aggressive behavior, or memory loss. Patients have also reported incidence of seizure within a month of starting varenicline, despite having no previous history of seizure.
“Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately,” the FDA recommended.
Find the full announcement on the FDA website.
*Correction, 3/11/2015: An earlier version of this article misstated one of the side effects of varenicline.
The Food and Drug Administration is warning physicians and patients that taking varenicline for smoking cessation can change a patient’s reaction to alcohol and can cause seizures* in patients without prior history.
Some patients who have drunk alcohol while taking varenicline, marketed as Chantix, have reported decreased tolerance to alcohol, including symptoms such as increased drunkenness, unusual or aggressive behavior, or memory loss. Patients have also reported incidence of seizure within a month of starting varenicline, despite having no previous history of seizure.
“Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately,” the FDA recommended.
Find the full announcement on the FDA website.
*Correction, 3/11/2015: An earlier version of this article misstated one of the side effects of varenicline.
All IHS Hospitals Now Baby-Friendly
With 3 recent additions—Northern Navajo Medical Center and Gallup Indian Medical Center, both in New Mexico, and Blackfeet Community Hospital in Montana—all 13 IHS hospitals that offer obstetric services have been designated as Baby-Friendly facilities.
Related: Stopping Obesity in Its Infancy
IHS began its evidence-based Baby-Friendly Hospital Initiative (BFHI) in 2011 as part of First Lady Michelle Obama’s “Let’s Move! in Indian Country” campaign, aimed at reducing childhood obesity. Breast-feeding has been shown to significantly reduce the risk of type 2 diabetes for both mother and infant and reduce a baby’s risk of obesity by about one-third. The BFHI is co-administered by the World Health Organization and the United Nations International Children’s Emergency Fund.
Related: Diabetes Report: The News Isn't Good
Through the Baby-Friendly program, new mothers are educated about and staff are trained to support breast-feeding. Since the program began, IHS says rates of breast-feeding initiation have been consistently in the 90th percentile.
With 3 recent additions—Northern Navajo Medical Center and Gallup Indian Medical Center, both in New Mexico, and Blackfeet Community Hospital in Montana—all 13 IHS hospitals that offer obstetric services have been designated as Baby-Friendly facilities.
Related: Stopping Obesity in Its Infancy
IHS began its evidence-based Baby-Friendly Hospital Initiative (BFHI) in 2011 as part of First Lady Michelle Obama’s “Let’s Move! in Indian Country” campaign, aimed at reducing childhood obesity. Breast-feeding has been shown to significantly reduce the risk of type 2 diabetes for both mother and infant and reduce a baby’s risk of obesity by about one-third. The BFHI is co-administered by the World Health Organization and the United Nations International Children’s Emergency Fund.
Related: Diabetes Report: The News Isn't Good
Through the Baby-Friendly program, new mothers are educated about and staff are trained to support breast-feeding. Since the program began, IHS says rates of breast-feeding initiation have been consistently in the 90th percentile.
With 3 recent additions—Northern Navajo Medical Center and Gallup Indian Medical Center, both in New Mexico, and Blackfeet Community Hospital in Montana—all 13 IHS hospitals that offer obstetric services have been designated as Baby-Friendly facilities.
Related: Stopping Obesity in Its Infancy
IHS began its evidence-based Baby-Friendly Hospital Initiative (BFHI) in 2011 as part of First Lady Michelle Obama’s “Let’s Move! in Indian Country” campaign, aimed at reducing childhood obesity. Breast-feeding has been shown to significantly reduce the risk of type 2 diabetes for both mother and infant and reduce a baby’s risk of obesity by about one-third. The BFHI is co-administered by the World Health Organization and the United Nations International Children’s Emergency Fund.
Related: Diabetes Report: The News Isn't Good
Through the Baby-Friendly program, new mothers are educated about and staff are trained to support breast-feeding. Since the program began, IHS says rates of breast-feeding initiation have been consistently in the 90th percentile.
FDA’s mobile app provides real-time drug shortage information
A mobile app that provides up-to-date information on drug shortages has been launched by the Food and Drug Administration, the agency has announced.
The mobile application is “specifically designed to speed public access to valuable information about drug shortages,” namely, current and resolved drug shortages and discontinuations of drug shortages, according to the FDA statement. Clinicians and others can search by a drug’s generic name, active ingredient, or therapeutic category, and also can use the app to report a drug shortage or a supply issue to the FDA.
The app “is an innovative tool that will offer easier and faster access to important drug shortage information,” Capt. Valerie Jensen, R.Ph., associate director of the drug shortages program in the FDA’s Center for Drug Evaluation and Research, said in the statement. “The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” she added.
The app is free and can be downloaded via iTunes for Apple devices and the Google Play store for Android devices, searching for “FDA Drug Shortages.”
More information on drug shortages is available on the FDA’s web site at http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.
A mobile app that provides up-to-date information on drug shortages has been launched by the Food and Drug Administration, the agency has announced.
The mobile application is “specifically designed to speed public access to valuable information about drug shortages,” namely, current and resolved drug shortages and discontinuations of drug shortages, according to the FDA statement. Clinicians and others can search by a drug’s generic name, active ingredient, or therapeutic category, and also can use the app to report a drug shortage or a supply issue to the FDA.
The app “is an innovative tool that will offer easier and faster access to important drug shortage information,” Capt. Valerie Jensen, R.Ph., associate director of the drug shortages program in the FDA’s Center for Drug Evaluation and Research, said in the statement. “The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” she added.
The app is free and can be downloaded via iTunes for Apple devices and the Google Play store for Android devices, searching for “FDA Drug Shortages.”
More information on drug shortages is available on the FDA’s web site at http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.
A mobile app that provides up-to-date information on drug shortages has been launched by the Food and Drug Administration, the agency has announced.
The mobile application is “specifically designed to speed public access to valuable information about drug shortages,” namely, current and resolved drug shortages and discontinuations of drug shortages, according to the FDA statement. Clinicians and others can search by a drug’s generic name, active ingredient, or therapeutic category, and also can use the app to report a drug shortage or a supply issue to the FDA.
The app “is an innovative tool that will offer easier and faster access to important drug shortage information,” Capt. Valerie Jensen, R.Ph., associate director of the drug shortages program in the FDA’s Center for Drug Evaluation and Research, said in the statement. “The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” she added.
The app is free and can be downloaded via iTunes for Apple devices and the Google Play store for Android devices, searching for “FDA Drug Shortages.”
More information on drug shortages is available on the FDA’s web site at http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.
FROM THE FDA
Suffocation suicides increasing in adolescents, young adults
The rates of suicide by suffocation increased significantly in people aged 10-24 years from 1994 to 2012, according to a report from the Centers for Disease Control and Prevention.
The suffocation suicide rate for males was 3.0/100,000 in 1994, and increased to 4.5/100,000 by 2012. For females, the rate more than tripled, from 0.5/100,000 to 1.7/100,000 in 2012. The rates of firearm and poisoning suicides either decreased or remained steady for both males and females. The overall suicide rate for males decreased slightly from 1994 to 2012, and the rate for females increased slightly, the CDC said.
The increase in suffocation suicides and its high lethality “underscores the importance of early prevention strategies to reduce onset of suicidal thoughts in young persons and to help identify persons who are contemplating suicide or who are at greater risk for suicide,” the investigators wrote.
Find the full study in the MMWR (2015;64:201-5).
The rates of suicide by suffocation increased significantly in people aged 10-24 years from 1994 to 2012, according to a report from the Centers for Disease Control and Prevention.
The suffocation suicide rate for males was 3.0/100,000 in 1994, and increased to 4.5/100,000 by 2012. For females, the rate more than tripled, from 0.5/100,000 to 1.7/100,000 in 2012. The rates of firearm and poisoning suicides either decreased or remained steady for both males and females. The overall suicide rate for males decreased slightly from 1994 to 2012, and the rate for females increased slightly, the CDC said.
The increase in suffocation suicides and its high lethality “underscores the importance of early prevention strategies to reduce onset of suicidal thoughts in young persons and to help identify persons who are contemplating suicide or who are at greater risk for suicide,” the investigators wrote.
Find the full study in the MMWR (2015;64:201-5).
The rates of suicide by suffocation increased significantly in people aged 10-24 years from 1994 to 2012, according to a report from the Centers for Disease Control and Prevention.
The suffocation suicide rate for males was 3.0/100,000 in 1994, and increased to 4.5/100,000 by 2012. For females, the rate more than tripled, from 0.5/100,000 to 1.7/100,000 in 2012. The rates of firearm and poisoning suicides either decreased or remained steady for both males and females. The overall suicide rate for males decreased slightly from 1994 to 2012, and the rate for females increased slightly, the CDC said.
The increase in suffocation suicides and its high lethality “underscores the importance of early prevention strategies to reduce onset of suicidal thoughts in young persons and to help identify persons who are contemplating suicide or who are at greater risk for suicide,” the investigators wrote.
Find the full study in the MMWR (2015;64:201-5).
Secondhand Smoke Problem Persists
Secondhand smoking (SHS) has declined dramatically—from 1 in 2 nonsmokers exposed to SHS between 1999 and 2000 to 1 in 4 between 2011 and 2012—thanks largely to changes in knowledge and habits. Since 2002, 26 states and the District of Columbia have implemented smoking bans for worksites, restaurants, and bars. And the proportion of smoke-free households in the U.S. nearly doubled, from 43% between 1992 and 1993 to 83% between 2010 and 2011, according to National Health and Nutrition Examination Survey data.
Related: Zeroing Out Tobacco Use
Nonetheless, 58 million people in the U.S. are exposed to SHS. Moreover, SHS kills > 400 infants and 41,000 adult nonsmokers every year, according to the CDC. The most vulnerable are children aged 3 to 11 years (2 in 5 are exposed to SHS), blacks (nearly half are exposed), people living below the poverty level, and home renters.
There is no risk-free level of SHS exposure, according to a study reported in the Morbidity and Mortality Weekly Report’s (MMWR’s) Vital Signs: Disparities in Nonsmokers’ Exposure to Secondhand Smoke—United States, 1999-2012. But eliminating smoking in indoor spaces fully protects nonsmokers from exposure to SHS. About half the U.S. population is covered by state or local smoke-free laws, but the home is still the prime source of smoking exposure, particularly in rental housing, multiunit housing, or public housing. The U.S. Department of Housing and Urban Development is encouraging smoke-free policies in subsidized and public housing and is creating smoke-free environments for employees, customers, and partners. As of October 2014, several hundred housing authorities had instituted such policies, including all 20 in Maine, according to the MMWR report.
Related: Evaluating Patient Barriers to Tobacco Cessation Treatment
The CDC offers suggestions on how to cut down on SHS exposure. For health care professionals, these include asking patients about their smoking habits and encouraging them to quit if they smoke. Other suggestions include letting patients know that opening a window or using fans or air fresheners is not enough to make homes and cars smoke free, as well as emphasizing the importance of not allowing anyone to smoke around children, and especially with children, avoiding public places where smoking is allowed.
Secondhand smoking (SHS) has declined dramatically—from 1 in 2 nonsmokers exposed to SHS between 1999 and 2000 to 1 in 4 between 2011 and 2012—thanks largely to changes in knowledge and habits. Since 2002, 26 states and the District of Columbia have implemented smoking bans for worksites, restaurants, and bars. And the proportion of smoke-free households in the U.S. nearly doubled, from 43% between 1992 and 1993 to 83% between 2010 and 2011, according to National Health and Nutrition Examination Survey data.
Related: Zeroing Out Tobacco Use
Nonetheless, 58 million people in the U.S. are exposed to SHS. Moreover, SHS kills > 400 infants and 41,000 adult nonsmokers every year, according to the CDC. The most vulnerable are children aged 3 to 11 years (2 in 5 are exposed to SHS), blacks (nearly half are exposed), people living below the poverty level, and home renters.
There is no risk-free level of SHS exposure, according to a study reported in the Morbidity and Mortality Weekly Report’s (MMWR’s) Vital Signs: Disparities in Nonsmokers’ Exposure to Secondhand Smoke—United States, 1999-2012. But eliminating smoking in indoor spaces fully protects nonsmokers from exposure to SHS. About half the U.S. population is covered by state or local smoke-free laws, but the home is still the prime source of smoking exposure, particularly in rental housing, multiunit housing, or public housing. The U.S. Department of Housing and Urban Development is encouraging smoke-free policies in subsidized and public housing and is creating smoke-free environments for employees, customers, and partners. As of October 2014, several hundred housing authorities had instituted such policies, including all 20 in Maine, according to the MMWR report.
Related: Evaluating Patient Barriers to Tobacco Cessation Treatment
The CDC offers suggestions on how to cut down on SHS exposure. For health care professionals, these include asking patients about their smoking habits and encouraging them to quit if they smoke. Other suggestions include letting patients know that opening a window or using fans or air fresheners is not enough to make homes and cars smoke free, as well as emphasizing the importance of not allowing anyone to smoke around children, and especially with children, avoiding public places where smoking is allowed.
Secondhand smoking (SHS) has declined dramatically—from 1 in 2 nonsmokers exposed to SHS between 1999 and 2000 to 1 in 4 between 2011 and 2012—thanks largely to changes in knowledge and habits. Since 2002, 26 states and the District of Columbia have implemented smoking bans for worksites, restaurants, and bars. And the proportion of smoke-free households in the U.S. nearly doubled, from 43% between 1992 and 1993 to 83% between 2010 and 2011, according to National Health and Nutrition Examination Survey data.
Related: Zeroing Out Tobacco Use
Nonetheless, 58 million people in the U.S. are exposed to SHS. Moreover, SHS kills > 400 infants and 41,000 adult nonsmokers every year, according to the CDC. The most vulnerable are children aged 3 to 11 years (2 in 5 are exposed to SHS), blacks (nearly half are exposed), people living below the poverty level, and home renters.
There is no risk-free level of SHS exposure, according to a study reported in the Morbidity and Mortality Weekly Report’s (MMWR’s) Vital Signs: Disparities in Nonsmokers’ Exposure to Secondhand Smoke—United States, 1999-2012. But eliminating smoking in indoor spaces fully protects nonsmokers from exposure to SHS. About half the U.S. population is covered by state or local smoke-free laws, but the home is still the prime source of smoking exposure, particularly in rental housing, multiunit housing, or public housing. The U.S. Department of Housing and Urban Development is encouraging smoke-free policies in subsidized and public housing and is creating smoke-free environments for employees, customers, and partners. As of October 2014, several hundred housing authorities had instituted such policies, including all 20 in Maine, according to the MMWR report.
Related: Evaluating Patient Barriers to Tobacco Cessation Treatment
The CDC offers suggestions on how to cut down on SHS exposure. For health care professionals, these include asking patients about their smoking habits and encouraging them to quit if they smoke. Other suggestions include letting patients know that opening a window or using fans or air fresheners is not enough to make homes and cars smoke free, as well as emphasizing the importance of not allowing anyone to smoke around children, and especially with children, avoiding public places where smoking is allowed.
FDA panel recommends two new strains for 2015-2016 influenza vaccines
SILVER SPRING, MD.– Two components of the trivalent and quadrivalent influenza vaccines used during the current season should be replaced for the 2015-2016 vaccine, including the influenza A(H3N2) component, a Food and Drug Administration advisory panel has stated.
During the current season, most of the influenza activity in the United States has been due to influenza A(H3N2), and more than two-thirds of the A(H3N2) viruses tested at the Centers for Disease Control and Prevention have “drifted” from the A (H3N2) strain included in the current vaccines, reducing their effectiveness.
The FDA’s Vaccines and Related Biologicals Products Advisory Committee voted at a meeting March 4 to recommend that the following viruses be used for the 2015-2016 trivalent vaccine: an A/California/7/2009 (H1N1)pdm09-like virus; an A/Switzerland/9715293/2013 (H3N2)-like virus; and a B/Phuket/3073/2013-like virus (B/Yamagata lineage). The A(H3N2) strain and the B/Yamagata lineage strain would replace the strains in the current vaccine.
The committee recommended a B/Brisbane/60/2008-like virus (B/Victoria lineage) for the second influenza B strain in the quadrivalent vaccine, which is included in the current quadrivalent vaccine. The panel votes separately on the strains; all votes were unanimous, except for the vote on the B/Yamagata lineage strain in the trivalent vaccine, which was supported by a 14-1 vote.
The FDA panel’s recommendation is the same as the recommendation made recently by the World Health Organization for next season’s influenza vaccines in the Northern Hemisphere. Every year, the FDA panel meets at this time and considers the WHO recommendation, as well as information that includes influenza surveillance and epidemiology data in North America and worldwide.
This season has been “moderately severe” and started about 4 weeks earlier than average, peaking in late December and early January, according to Dr. Lisa Grohskopf of the epidemiology & prevention branch in the CDC’s influenza division.
Hospitalization rates for laboratory-confirmed influenza this season have been markedly higher among people aged 65 years and older, compared with younger age groups. As of Feb. 21, the preliminary estimate of hospitalizations in this age group was 51.7 cases per 100,000 people, compared with about 27 per 100,000 during the last season. This is the highest rate recorded for this age group since surveillance began during the 2005-2006 season, she added.
To date, there have been 92 pediatric deaths associated with influenza, compared with 109 reported during the 2013-2014 season, 171 during 2012-2013, and 37 during 2011-2012.
When asked why the hospitalization rate has been so high among the elderly, Dr. Grohskopf said that A(H3N2)-predominant seasons tend to be associated with more severe disease, and vaccine efficacy this season was reduced.
The data for the pediatric deaths are incomplete, but most of these cases have been associated with influenza A, and the subtypes tested have been A(H3N2). Whether they represent drifted strains is not yet known, she said. The children’s vaccination status also is not yet known, but historically about 85%-90% of influenza-associated deaths in children are in those who were not vaccinated, she noted.
Updated estimates of the current vaccine effectiveness against influenza A (H3N2) viruses, provided by the CDC on Feb. 26, is 18%. For all influenza viruses overall, estimated effectiveness is 19%, indicating that the flu vaccine reduced a person’s risk of having to seek medical care at a doctor’s office for flu illness by 19%, according to the update. During seasons when the vaccine is a good match for circulating viruses, vaccine effectiveness is in the 60% range, according to speakers at the FDA panel meeting.
The FDA usually follows the recommendations of its panel members. None of the panelists had disclosures.
SILVER SPRING, MD.– Two components of the trivalent and quadrivalent influenza vaccines used during the current season should be replaced for the 2015-2016 vaccine, including the influenza A(H3N2) component, a Food and Drug Administration advisory panel has stated.
During the current season, most of the influenza activity in the United States has been due to influenza A(H3N2), and more than two-thirds of the A(H3N2) viruses tested at the Centers for Disease Control and Prevention have “drifted” from the A (H3N2) strain included in the current vaccines, reducing their effectiveness.
The FDA’s Vaccines and Related Biologicals Products Advisory Committee voted at a meeting March 4 to recommend that the following viruses be used for the 2015-2016 trivalent vaccine: an A/California/7/2009 (H1N1)pdm09-like virus; an A/Switzerland/9715293/2013 (H3N2)-like virus; and a B/Phuket/3073/2013-like virus (B/Yamagata lineage). The A(H3N2) strain and the B/Yamagata lineage strain would replace the strains in the current vaccine.
The committee recommended a B/Brisbane/60/2008-like virus (B/Victoria lineage) for the second influenza B strain in the quadrivalent vaccine, which is included in the current quadrivalent vaccine. The panel votes separately on the strains; all votes were unanimous, except for the vote on the B/Yamagata lineage strain in the trivalent vaccine, which was supported by a 14-1 vote.
The FDA panel’s recommendation is the same as the recommendation made recently by the World Health Organization for next season’s influenza vaccines in the Northern Hemisphere. Every year, the FDA panel meets at this time and considers the WHO recommendation, as well as information that includes influenza surveillance and epidemiology data in North America and worldwide.
This season has been “moderately severe” and started about 4 weeks earlier than average, peaking in late December and early January, according to Dr. Lisa Grohskopf of the epidemiology & prevention branch in the CDC’s influenza division.
Hospitalization rates for laboratory-confirmed influenza this season have been markedly higher among people aged 65 years and older, compared with younger age groups. As of Feb. 21, the preliminary estimate of hospitalizations in this age group was 51.7 cases per 100,000 people, compared with about 27 per 100,000 during the last season. This is the highest rate recorded for this age group since surveillance began during the 2005-2006 season, she added.
To date, there have been 92 pediatric deaths associated with influenza, compared with 109 reported during the 2013-2014 season, 171 during 2012-2013, and 37 during 2011-2012.
When asked why the hospitalization rate has been so high among the elderly, Dr. Grohskopf said that A(H3N2)-predominant seasons tend to be associated with more severe disease, and vaccine efficacy this season was reduced.
The data for the pediatric deaths are incomplete, but most of these cases have been associated with influenza A, and the subtypes tested have been A(H3N2). Whether they represent drifted strains is not yet known, she said. The children’s vaccination status also is not yet known, but historically about 85%-90% of influenza-associated deaths in children are in those who were not vaccinated, she noted.
Updated estimates of the current vaccine effectiveness against influenza A (H3N2) viruses, provided by the CDC on Feb. 26, is 18%. For all influenza viruses overall, estimated effectiveness is 19%, indicating that the flu vaccine reduced a person’s risk of having to seek medical care at a doctor’s office for flu illness by 19%, according to the update. During seasons when the vaccine is a good match for circulating viruses, vaccine effectiveness is in the 60% range, according to speakers at the FDA panel meeting.
The FDA usually follows the recommendations of its panel members. None of the panelists had disclosures.
SILVER SPRING, MD.– Two components of the trivalent and quadrivalent influenza vaccines used during the current season should be replaced for the 2015-2016 vaccine, including the influenza A(H3N2) component, a Food and Drug Administration advisory panel has stated.
During the current season, most of the influenza activity in the United States has been due to influenza A(H3N2), and more than two-thirds of the A(H3N2) viruses tested at the Centers for Disease Control and Prevention have “drifted” from the A (H3N2) strain included in the current vaccines, reducing their effectiveness.
The FDA’s Vaccines and Related Biologicals Products Advisory Committee voted at a meeting March 4 to recommend that the following viruses be used for the 2015-2016 trivalent vaccine: an A/California/7/2009 (H1N1)pdm09-like virus; an A/Switzerland/9715293/2013 (H3N2)-like virus; and a B/Phuket/3073/2013-like virus (B/Yamagata lineage). The A(H3N2) strain and the B/Yamagata lineage strain would replace the strains in the current vaccine.
The committee recommended a B/Brisbane/60/2008-like virus (B/Victoria lineage) for the second influenza B strain in the quadrivalent vaccine, which is included in the current quadrivalent vaccine. The panel votes separately on the strains; all votes were unanimous, except for the vote on the B/Yamagata lineage strain in the trivalent vaccine, which was supported by a 14-1 vote.
The FDA panel’s recommendation is the same as the recommendation made recently by the World Health Organization for next season’s influenza vaccines in the Northern Hemisphere. Every year, the FDA panel meets at this time and considers the WHO recommendation, as well as information that includes influenza surveillance and epidemiology data in North America and worldwide.
This season has been “moderately severe” and started about 4 weeks earlier than average, peaking in late December and early January, according to Dr. Lisa Grohskopf of the epidemiology & prevention branch in the CDC’s influenza division.
Hospitalization rates for laboratory-confirmed influenza this season have been markedly higher among people aged 65 years and older, compared with younger age groups. As of Feb. 21, the preliminary estimate of hospitalizations in this age group was 51.7 cases per 100,000 people, compared with about 27 per 100,000 during the last season. This is the highest rate recorded for this age group since surveillance began during the 2005-2006 season, she added.
To date, there have been 92 pediatric deaths associated with influenza, compared with 109 reported during the 2013-2014 season, 171 during 2012-2013, and 37 during 2011-2012.
When asked why the hospitalization rate has been so high among the elderly, Dr. Grohskopf said that A(H3N2)-predominant seasons tend to be associated with more severe disease, and vaccine efficacy this season was reduced.
The data for the pediatric deaths are incomplete, but most of these cases have been associated with influenza A, and the subtypes tested have been A(H3N2). Whether they represent drifted strains is not yet known, she said. The children’s vaccination status also is not yet known, but historically about 85%-90% of influenza-associated deaths in children are in those who were not vaccinated, she noted.
Updated estimates of the current vaccine effectiveness against influenza A (H3N2) viruses, provided by the CDC on Feb. 26, is 18%. For all influenza viruses overall, estimated effectiveness is 19%, indicating that the flu vaccine reduced a person’s risk of having to seek medical care at a doctor’s office for flu illness by 19%, according to the update. During seasons when the vaccine is a good match for circulating viruses, vaccine effectiveness is in the 60% range, according to speakers at the FDA panel meeting.
The FDA usually follows the recommendations of its panel members. None of the panelists had disclosures.
AT AN FDA ADVISORY COMMITTEE MEETING
New Leadership at IHS as McSwain Replaces Roubideaux
Dr. Yvette Roubideaux’s official capacity with IHS has come to a close, at least for now, as her nomination to serve a second 4-year term as IHS director has stagnated in the Senate.
Related: IHS Hiring More Veterans
HHS Secretary Sylvia M. Burwell appointed Dr. Roubideaux Senior Advisor to the Secretary for American Indians and Alaska Natives, a new position not listed in the HHS organizational chart. This appointment comes 1 week after a provision in a 2009 appropriations act was cited that limits the amount of time a nominee can serve in an acting position for which he or she is nominated.
Robert G. McSwain, MPA, has assumed duty as acting director of IHS, a position he served prior to Dr. Roubideaux’s appointment in 2009.
Related: Sebelius and Roubideaux Confirmed for HHS Positions (2009)
“I have full confidence in [Mr. McSwain’s] ability to lead the agency while my nomination is in progress,” Dr. Roubideaux stated in a February 10, 2015, e-mail correspondence with IHS staff.
In May 2013, President Obama nominated Dr. Roubideaux to serve a second term as IHS director, but the Democratic-controlled Senate did not reconfirm her. HHS Deputy Assistant Secretary for Public Affairs for Human Services Mark Weber told the Indian Country Today Media Network that Dr. Roubideaux was not experiencing a demotion. “In fact,” Mr. Weber explained, “it provides Dr. Roubideaux a broader portfolio of initiatives and policies that impact Indian country.”
“A position close to the secretary, such as an advisor, is an incredible position of power,” he added.
Dr. Yvette Roubideaux’s official capacity with IHS has come to a close, at least for now, as her nomination to serve a second 4-year term as IHS director has stagnated in the Senate.
Related: IHS Hiring More Veterans
HHS Secretary Sylvia M. Burwell appointed Dr. Roubideaux Senior Advisor to the Secretary for American Indians and Alaska Natives, a new position not listed in the HHS organizational chart. This appointment comes 1 week after a provision in a 2009 appropriations act was cited that limits the amount of time a nominee can serve in an acting position for which he or she is nominated.
Robert G. McSwain, MPA, has assumed duty as acting director of IHS, a position he served prior to Dr. Roubideaux’s appointment in 2009.
Related: Sebelius and Roubideaux Confirmed for HHS Positions (2009)
“I have full confidence in [Mr. McSwain’s] ability to lead the agency while my nomination is in progress,” Dr. Roubideaux stated in a February 10, 2015, e-mail correspondence with IHS staff.
In May 2013, President Obama nominated Dr. Roubideaux to serve a second term as IHS director, but the Democratic-controlled Senate did not reconfirm her. HHS Deputy Assistant Secretary for Public Affairs for Human Services Mark Weber told the Indian Country Today Media Network that Dr. Roubideaux was not experiencing a demotion. “In fact,” Mr. Weber explained, “it provides Dr. Roubideaux a broader portfolio of initiatives and policies that impact Indian country.”
“A position close to the secretary, such as an advisor, is an incredible position of power,” he added.
Dr. Yvette Roubideaux’s official capacity with IHS has come to a close, at least for now, as her nomination to serve a second 4-year term as IHS director has stagnated in the Senate.
Related: IHS Hiring More Veterans
HHS Secretary Sylvia M. Burwell appointed Dr. Roubideaux Senior Advisor to the Secretary for American Indians and Alaska Natives, a new position not listed in the HHS organizational chart. This appointment comes 1 week after a provision in a 2009 appropriations act was cited that limits the amount of time a nominee can serve in an acting position for which he or she is nominated.
Robert G. McSwain, MPA, has assumed duty as acting director of IHS, a position he served prior to Dr. Roubideaux’s appointment in 2009.
Related: Sebelius and Roubideaux Confirmed for HHS Positions (2009)
“I have full confidence in [Mr. McSwain’s] ability to lead the agency while my nomination is in progress,” Dr. Roubideaux stated in a February 10, 2015, e-mail correspondence with IHS staff.
In May 2013, President Obama nominated Dr. Roubideaux to serve a second term as IHS director, but the Democratic-controlled Senate did not reconfirm her. HHS Deputy Assistant Secretary for Public Affairs for Human Services Mark Weber told the Indian Country Today Media Network that Dr. Roubideaux was not experiencing a demotion. “In fact,” Mr. Weber explained, “it provides Dr. Roubideaux a broader portfolio of initiatives and policies that impact Indian country.”
“A position close to the secretary, such as an advisor, is an incredible position of power,” he added.
FDA: Limit testosterone use to men with specific medical conditions
Testosterone therapy is not appropriate for men with age-related low testosterone because it may be associated with an increased risk of cardiovascular events, the Food and Drug Administration has determined.
The agency will now require labeling changes to all prescription testosterone products, clarifying their appropriate use, and warning about a possible increased risk of heart attack and stroke in any patient taking the hormone. Testosterone is approved only for men with specific medical conditions, but is widely used off label for men with age-related low testosterone.
“Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy,” an FDA statement said. “We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.”
The statement arose from a September 2014 recommendation by the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. The groups reviewed studies of aging men using testosterone – some of which reported an increased risk of heart attack, stroke, or death associated with testosterone treatment – and voted 20-1 that the current indication, as worded in the labeling for all testosterone products, should be tightened to make it clear that testosterone therapy is not indicated for men with age-related reductions in testosterone.
Any clinician who prescribes testosterone to a patient who later experiences a cardiovascular event should report that toFDA’s MedWatch Safety Information and Adverse Event Reporting Program.
On Twitter @alz_gal
Testosterone therapy is not appropriate for men with age-related low testosterone because it may be associated with an increased risk of cardiovascular events, the Food and Drug Administration has determined.
The agency will now require labeling changes to all prescription testosterone products, clarifying their appropriate use, and warning about a possible increased risk of heart attack and stroke in any patient taking the hormone. Testosterone is approved only for men with specific medical conditions, but is widely used off label for men with age-related low testosterone.
“Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy,” an FDA statement said. “We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.”
The statement arose from a September 2014 recommendation by the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. The groups reviewed studies of aging men using testosterone – some of which reported an increased risk of heart attack, stroke, or death associated with testosterone treatment – and voted 20-1 that the current indication, as worded in the labeling for all testosterone products, should be tightened to make it clear that testosterone therapy is not indicated for men with age-related reductions in testosterone.
Any clinician who prescribes testosterone to a patient who later experiences a cardiovascular event should report that toFDA’s MedWatch Safety Information and Adverse Event Reporting Program.
On Twitter @alz_gal
Testosterone therapy is not appropriate for men with age-related low testosterone because it may be associated with an increased risk of cardiovascular events, the Food and Drug Administration has determined.
The agency will now require labeling changes to all prescription testosterone products, clarifying their appropriate use, and warning about a possible increased risk of heart attack and stroke in any patient taking the hormone. Testosterone is approved only for men with specific medical conditions, but is widely used off label for men with age-related low testosterone.
“Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy,” an FDA statement said. “We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.”
The statement arose from a September 2014 recommendation by the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. The groups reviewed studies of aging men using testosterone – some of which reported an increased risk of heart attack, stroke, or death associated with testosterone treatment – and voted 20-1 that the current indication, as worded in the labeling for all testosterone products, should be tightened to make it clear that testosterone therapy is not indicated for men with age-related reductions in testosterone.
Any clinician who prescribes testosterone to a patient who later experiences a cardiovascular event should report that toFDA’s MedWatch Safety Information and Adverse Event Reporting Program.
On Twitter @alz_gal
Elementary, My Dear Watson? Supercomputer Builds Foundation for Clinical Decisions
The same technology that led the supercomputer Watson to victory over long-term Jeopardy! winner Ken Jennings in 2011 may also help physicians access clinical answers faster. The VA is launching a 2-year pilot study to assess whether IBM computer technology can make searching for information from published studies and medical records easier.
Related: Searching for Information the Circadian Way
Watson can read and understand natural language, allowing it to analyze unstructured data, which make up as much as 80% of data today. Through repeated use, Watson “gets smarter,” IBM says, by tracking feedback from users and learning from both successes and failures. IBM is already working with several health care organizations to apply Watson’s cognitive capabilities to identifying and analyzing cancer treatment options.
In addition to building a foundation for evidence-based clinical decisions, the effort may benefit patients. “A tool that can help a clinician quickly collect, combine, and present information will allow them to spend more time listening and interacting with the veteran,” said VA Interim Under Secretary for Health Carolyn Clancy, MD, in a VA press release.
The same technology that led the supercomputer Watson to victory over long-term Jeopardy! winner Ken Jennings in 2011 may also help physicians access clinical answers faster. The VA is launching a 2-year pilot study to assess whether IBM computer technology can make searching for information from published studies and medical records easier.
Related: Searching for Information the Circadian Way
Watson can read and understand natural language, allowing it to analyze unstructured data, which make up as much as 80% of data today. Through repeated use, Watson “gets smarter,” IBM says, by tracking feedback from users and learning from both successes and failures. IBM is already working with several health care organizations to apply Watson’s cognitive capabilities to identifying and analyzing cancer treatment options.
In addition to building a foundation for evidence-based clinical decisions, the effort may benefit patients. “A tool that can help a clinician quickly collect, combine, and present information will allow them to spend more time listening and interacting with the veteran,” said VA Interim Under Secretary for Health Carolyn Clancy, MD, in a VA press release.
The same technology that led the supercomputer Watson to victory over long-term Jeopardy! winner Ken Jennings in 2011 may also help physicians access clinical answers faster. The VA is launching a 2-year pilot study to assess whether IBM computer technology can make searching for information from published studies and medical records easier.
Related: Searching for Information the Circadian Way
Watson can read and understand natural language, allowing it to analyze unstructured data, which make up as much as 80% of data today. Through repeated use, Watson “gets smarter,” IBM says, by tracking feedback from users and learning from both successes and failures. IBM is already working with several health care organizations to apply Watson’s cognitive capabilities to identifying and analyzing cancer treatment options.
In addition to building a foundation for evidence-based clinical decisions, the effort may benefit patients. “A tool that can help a clinician quickly collect, combine, and present information will allow them to spend more time listening and interacting with the veteran,” said VA Interim Under Secretary for Health Carolyn Clancy, MD, in a VA press release.