Category Archives: Food and Drug Administration
New Report Widens Information on Veteran Suicide
The Department of Veterans Affairs (VA) has released a comprehensive report on Veterans who die by suicide—include veterans who had not sought VA health care services. Previous reports included information only on those who had sought those services. The VA has recently implemented broader suicide prevention initiatives, including a toll-free Veterans Crisis Line; placement of suicide prevention coordinators at all VA medical centers and large outpatient facilities; and improvements in case management and reporting. Immediate help for veterans is available at www.VeteransCrisisLine.net or by calling the Crisis Line at 1-800-273-8255 (push 1) or texting 838255. Read more on military.
FDA Approves Generic Version for Cancer Drug Doxil in Short Supply
The U.S. Food and Drug Administration (FDA) has approved the first generic version of widely used cancer drug Doxil (doxorubicin hydrochloride liposome injection). This approval is critical because the drug is currently on the FDA’s drug shortage list. The agency is using a priority review system to expedite the review of generic applications to help stem shortages. Doxil is used for several cancers, including ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Read more on prescription drugs.
Stroke Victims Need Therapy Within 60 Minutes of Hospital Arrival
People having an ischemic stroke should receive clot-dissolving therapy within 60 minutes of arriving at the hospital, according to new American Stroke Association guidelines published in the journal Stroke. Ischemic stroke, which accounts for nine in 10 strokes, is caused by a blood clot in the arteries leading to the brain. According to the American Heart Association, calling 9-1-1 immediately after recognizing any of the warning signs of stroke—and getting to a stroke center as fast as possible—are critical steps for optimal stroke care. That’s because during an acute stroke, physicians must quickly evaluate and diagnose patients to determine whether they are eligible to receive the clot-dissolving drug recombinant tissue plasminogen activator which has to be given within hours of symptom starting.
Other new changes to stroke guidelines include:
- If feasible, transfer patients to the closest available certified primary care stroke center or comprehensive stroke center, which might involve air medical transport, though telemedicine with a stroke center may also be appropriate.
- Create multidisciplinary quality improvement committees within hospitals to review and monitor stroke care.
Read more on heart health.
The U.S. Food and Drug Administration (FDA) yesterday announced it is requiring the manufacturers of widely used sleeping pills that contain the active ingredient zolpidem, to lower current recommended doses. Recommended doses will be required to be lowered on drug labels that doctors use to prescribe medicines and on medication guides given to patients, for the following drugs: Ambien, Ambien CR, Edluar and Zolpimist. FDA is also urging physicians to prescribe the drugs at the lowest dose capable of treating the patient’s insomnia.
The FDA announcement is based on driving simulation and laboratory studies showing that, in some individuals, zolpidem blood levels the morning after use appear capable of impairing driving to a degree that increases the risk of a motor vehicle accident. Reducing deaths from motor vehicle accidents is a priority for the Centers for Disease Control and Prevention. While these deaths declined between 2000 and 2009, car crashes are still among the top ten causes of death for all Americans.
New data is driving the announcement, according to the FDA. “Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” said Dr. Unger. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”
Disabled Adults Have Very High Rates of Emergency Room Use
A review of medical expenditure data by researchers at the National Institutes of Health finds that disabled adults account for a disproportionately high amount of annual emergency room (ER) visits.
The study found that despite representing 17 percent of the working age U.S. population, adults with disabilities accounted for 39.2 percent of total emergency room visits. The researchers say the higher ER use is a problem not just because of the higher costs, but also because many disabled adults have non-urgent needs that are not met by the ER visits.
Recommendations to improve care for disabled adults include prevention and chronic condition management programs tailored for the functional limitations and service needs of people with disabilities, wider use of coordinated care systems for the disabled that provide case management, integration of psychosocial care and 24/7 access to medical assistance.
Read more on disability.
Change in Color of their Pills Keeps Some Patients from Taking Generic Drugs
A new study in JAMA Internal Medicine finds that some people stop taking their medicines when a generic becomes available if the color of the dispensed generic drug is different than the brand name drug they received previously.
The authors say the study shows the need for a reconsideration of the FDA’s current regulations that allow wide variation in the appearance of generic drugs.
Read more news about the Food and Drug Administration.
Mental Health Disorders Increase the Risk of Becoming a Victim of Domestic Violence
People diagnosed with mental illness are more likely than those who are not to be victims of domestic violence, according to a new study in PLoS One.
The researchers say the causality may run in both directions. Domestic violence can result in mental health problems and people with mental health problems are more likely to experience domestic violence. The researchers say studies they reviewed show that the link between domestic violence and mental health problems is a concern for both men and women.
Read more on mental health.
AAP Calls for Schools to Maintain Daily Recess and Breaks
A new policy statement from the American Academy of Pediatrics (AAP) calls on all schools to have daily recess and breaks in order to promote activity and a healthy lifestyle. According to the AAP, “safe and properly supervised recess offers children cognitive, physical, emotional and social benefits. It should be used as a complement to physical education classes, not a substitute, and whether it’s spent indoors or outdoors, recess should provide free, unstructured play or activity.” The AAP also says that recess should never be withheld as a punishment and the statement authors add that “minimizing or eliminating recess can negatively affect academic achievement, as growing evidence links recess to improved physical health, social skills and cognitive development.” Read more on physical activity.
Support and Solidarity Build Resilience Following Community Disasters
Community solidarity and support have remarkable benefits for communities coping with traumatic mass shootings, according to an American-Finnish research study recently published by the University of Turku. The researchers looked at the responses of four communities that suffered from similar tragedies in the United States and Finland. People in all four communities expressed their need for belonging after the shootings. According to the researchers, after each of the four incidents the communities held events including mass gatherings, communal vigils and spontaneously erected monuments to the victims. The researchers say that all these efforts demonstrated that the community was in shock, yet united, and able to focus attention on their collective loss and on each other. Read more on community health.
FDA Approved Most Drugs in 16 Years
Reuters is reporting that the U.S. Food and Drug Administration (FDA) approved 39 drugs in 2012, the largest number in the past 16 years. Important new drugs approved this year include two weight loss medicines, drugs to treat resistant cystic fibrosis and tuberculosis and a drug to reduce the risk of stroke in people with irregular heartbeats. Read more on the U.S. Food and Drug Administration.
Post-storm Food Precautions from the USDA
As residents of four states hunker down to face Hurricane Isaac, the U.S. Department of Agriculture (USDA) urges anyone in the storm’s path to take precautions when using and preparing food after a severe storm. According to the USDA, power outages and flooding from weather emergencies compromise the safety of stored food. While people still have power, it is a good idea to access and download A Consumer’s Guide to Food Safety: Severe Storms and Hurricanes. USDA also has dedicated Twitter accounts with updated information on food preparation during and after the current severe weather: @FL_FSISAlert for Florida, @MS_FSISAlert for Mississippi and @LA_FSISAlert for Louisiana. USDA also has a “virtual representative”—Karen—available 24/7 online and on smartphones. Consumers can also find a live representative at the toll-free USDA Meat and Poultry Hotline by calling 1-888-MPHotline (1-888-674-6854) from 10 a.m. to 4 p.m. ET, Monday through Friday. Operators speak English and Spanish. Read regular updates from the National Hurricane Center.
Marijuana Use by Teens Impacts Intelligence Later On
Regular marijuana use by teens who continue the drug use into their adulthood can lead to an average drop in IQ of eight points, according to a new study from the Proceedings of the National Academy of Sciences. The study looked at more than 1,000 New Zealanders born in 1972 or 1973 who were tested at the ages of 13 and again at 38. The average IQ is 100, or the 50th percentile; an IQ of 92 would drop someone to the 29th percentile. “As an adolescent, your brain hasn’t fully developed. It’s undergoing some critical developmental changes,” said study author Madeline Meier, a postdoctoral research associate in psychology and neurology at Duke University, according to HealthDay. “This research suggests that because of that you are vulnerable to the effects of cannabis on your brain. If you start using as an adolescent and you keep using it, you are going to lose some of your mental abilities.” Read more on substance abuse.
Legionnaires’ Deaths and Illnesses Linked to Chicago Hotel
An outbreak of Legionnaires’ disease in an outbreak linked to a Chicago Marriott hotel has led to two people dying and six others falling ill, according to Reuters. Officials with the national hotel chain have contacted 80 percent of the approximately 8,500 people who stayed at the hotel from July 16 to August 16. Kathleen Ritger, MD, Medical Director over Communicable Disease at the Chicago Department of Public Health, has said there is “no ongoing health threat” at the location. Legionnaires’—a type of pneumonia—starts with high fever, chills and a cough and can lead to death in between 5 percent and 30 percent of cases, according to the Centers for Disease Control and Prevention. Read more on infectious diseases.
U.S. Court Strikes Down Graphic Warnings for Cigarette
The U.S. Court of Appeals in Washington has backed a lower court’s ruling that the U.S. Food and Drug Administration’s graphic warning labels for cigarettes constitute a First Amendment violation. Major tobacco manufacturers such as R.J. Reynolds Tobacco Co. have opposed the nine new labels, arguing they “went beyond factual information into anti-smoking advocacy,” accord to the Associated Press. The U.S. Department of Justice can appeal the ruling. Advocacy groups such as the Campaign for Tobacco-Free Kids are pushing for an appeal, saying the court’s 2-1 ruling “is wrong on the science and law, and it is by no means the final word on the new cigarette warnings.” Read an earlier Q&A with Deputy Director of the Tobacco Control Legal Consortium about the preliminary ruling.
AAP Says Circumcision Benefits Outweigh Risks, But Decision Should Be Parents’
The American Academy of Pediatrics (AAP) has revised its guidance on newborn male circumcision, stating the health benefits outweigh the risks, but it should still be up to parents to determine whether to perform the procedure. Male circumcision has been linked to reduced risk of sexually transmitted diseases, including HIV. The rate of circumcision has fallen dramatically since the 1970s, from approximately 80 percent to 55 percent in 2010. Still, AAP says parents should consult with their doctors and that the procedure might not be right for all newborn males. “We recognize that the topic cuts across many paradigms in your life — cultural, religious, ethnic, family tradition, aesthetic,” said Dr. Andrew Freedman, a member of the AAP’s task force that issued the new guidelines, toHealthDay. “We’re not in a position to make recommendations on those paradigms.” Read more on infant health.
Study: Physicians Who Use Electronic Health Records May Overlook Patients’ Mental Health Issues
Medical professionals who use electronic medical records (EMRs) are more likely than those who use paper medical records to overlook signs of depression in their patients, according to a new study University of Florida. The study is in the August issue of the Journal of General Internal Medicine. “While we don’t know why EMRs are associated with lower odds of depression treatment in patients with multiple conditions, we think that either they reduce the amount of interaction between patients and physicians or they focus a physician’s attention on physical health issues, pushing mental health issues off the radar screen,” said Jeffrey Harman, an associate professor and the Louis C. and Jane Gapenski Term Professor of Health Services Administration at the University of Florida College of Public Health and Health Professions and the study’s lead researcher. Read more on mental health.
Study: Special Needs Children at Higher Risk for Obesity
A first-of-its-kind study in the International Journal of Pediatrics finds that the majority of children and youth with special health care needs (CYSHCN) suffer from obesity and do not get the recommended 60 minutes of daily physical activity. The study was conducted by the Drexel University School of Public Health. While childhood obesity can lead to major health problems late in life—such as heart disease and diabetes—there are no national statistics on CYSHCN obesity. The percentage of typically developing children with obesity has increased to 17 percent from 5 percent over the past 30 years. Read more on obesity.
Fewer antibiotic prescriptions were dispensed by pharmacies for kids 17 and younger but prescriptions for ADHD drugs were up, according to a study by Food and Drug Administration researchers and published in Pediatrics. The researchers reviewed outpatient retail prescription databases. In addition to decreases in antibiotic prescriptions for children, the study also found decreases in allergy, pain and depression drugs as well as a 42 percent drop in cough and cold medicines for kids. The FDA issued an advisory in 2008 against using cough and cold drugs in very young kids.
In addition to increases in ADHD drugs, the study found higher rates of asthma drugs and contraceptives. Read more on prescription drugs.
A new study in Pediatrics looks at the practice of delaying infant vaccinations, which experts say can increase the risk of communicable disease outbreaks. The study found that in 2009, about 9.5 percent of parents in the Portland, Ore., area did not consistently follow the recommended vaccine schedule for infants and children up to nine months old, up from 2.5 percent in 2006. Children whose parents delayed shots had more visits to providers for shots, fewer total shots, and did not generally catch up later with the recommended vaccination schedule.
The researchers say negative media attention about vaccine safety likely contributed to the increase in parents delaying or limiting the number of immunizations, and say there are no known benefits to delaying vaccines in infants. Read more on vaccines.
The Food and Drug Administration (FDA) has expanded a bagged lettuce recall because of possible contamination with listeria bacteria, and recalled bagged spinach because of possible contamination with salmonella. No illnesses have been linked to either recall so far.
The FDA discovered the contaminated products during routine inspections.
Recent changes to the FDA’s product recall website may make it easier for people to find out whether they have bought or used a recalled product. Previously the information was available only in text form, but last month the agency created a table for each food recall it reports with information that includes the recall date, brand name, product description, the reason for the recall, the name of the company, and, perhaps most importantly, a photo of what the recalled package looks like. People may not remember a brand name but they can compare graphics and colors on a recalled package to what they have on pantry shelves or in the fridge.
The new chart won’t prevent food-borne disease outbreaks and other health problems linked to recalls from happening in the first place, of course, but may keep some people from getting sick or help people get medical treatment faster.
The Food and Drug Administration (FDA) has released a new report that details steps the agency is taking to ensure that imported food, drugs, medical devices and other regulated products meet the same standards for safety and quality as those manufactured in the United States.
According to the agency, global production of FDA-regulated goods and materials has grown significantly in the last decade:
- FDA-regulated products originate from more than 150 countries; 130,000 importers and 300,000 foreign facilities.
- Each year from 2005 through 2011, food imports have grown by an average of 10 percent, pharmaceutical products by nearly 13 percent and device imports by more than 10 percent.
- About half of all fresh fruits and 20 percent of fresh vegetables, as well as 80 percent of the seafood consumed in America, come from abroad.
- More than 80 percent of the active pharmaceutical ingredients used to make medicines are imported.
The agency says that through its international offices in Africa, Asia, Europe, Latin America and the Middle East, the FDA is increasing its knowledge base about local regulatory systems, and improving what foreign governments and industries know about FDA regulations and standards for products that will be sold in the United States. The agency says it is also collaborating to strengthen regulatory science and evidenced-based approaches to product safety and quality.
Read the Global Engagement Report.
Many low- and middle-income nations don’t have technologically advanced regulatory systems, which limits their oversight of food and drug safety, according to a new report from the Institute of Medicine. The report recommends 13 steps that the Food and Drug Administration (FDA) and other agencies can take over the next three to five years to bolster the safety systems in developing nations. They include:
- Developed nations should share technical expertise, training, and tools to strengthen the surveillance systems in developing countries.
- The United States should work with Mexico, the host of the next meeting of the G20 nations, to add food and medical product safety to the G20 agenda.
- FDA should evaluate its pilot Secure Supply Chain pilot program, which rewards firms that can track their products from manufacture to market with expedited entry into the U.S. market. If successful, FDA should expand the program to more drug firms and to food companies.
Read more food safety news.
The U.S. Departments of Health and Human Services (HHS) and Education have launched a new website to encourage children, parents, educators and communities to take action to stop and prevent bullying.
The website provides a map with detailed information on state laws and policies, interactive webisodes and videos for young people, practical strategies for schools and communities to ensure safe environments, and suggestions on how parents can talk about bullying with their children. Read more on a recent documentary that tells the stories of kids who were bullied.
A new study by scientists at Columbia University Mailman School of Public Health finds that neighborhood differences in rates of childhood asthma may be explained by varying levels of air pollution from trucks and residential heating oil. Read more on environmental health.