News you can use: health & drug safety updates
July 16, 2009
FDA Public Workshop: Providing Effective Information to Consumers about Prescription Drug Risks and BenefitsThe Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with FDA’s Office of the Commissioner (OC), is holding a public workshop on September 24 and 25, 2009 entitled ‘‘Providing Effective Information to Consumers About Prescription Drug Risks and Benefits.’’ This public workshop is intended to explore potential approaches that will result in written prescription drug information for consumers that is comprehensible, accurate, and easy to access.
July 1, 2009
On June 29 and 30, 2009, FDA held an advisory committee meeting in Adelphi, Maryland, about how to address the problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription products. For more information about the meeting, visit the Advisory Committee Web page. Acetaminophen is the generic name of a drug found in many common brand name OTC products such as Tylenol, as well as prescription products such as Vicodin and Percocet. Acetaminophen is an important drug, and its effectiveness in
June 17, 2009
Teenagers with asthma are “too busy” to use their medications and often do not believe in their benefits, say researchers who assessed health beliefs in young people with asthma. It has previously been suggested that poor adherence to asthma medications in individuals aged 15–20 years contributes substantially to asthma-related morbidity in that age group. However, there have been few adherence studies in this age group, despite the fact that the organizational and behavioral skills that largely determine adherence are developed during late adolescence.
June 9, 2009
One quarter of supplements tested by an independent company over the last decade have had some sort of problem. Some contained contaminants. Others had contents that did not match label claims. Some had ingredients that exceeded safe limits. Some contained real drugs masquerading as natural supplements. Examples found include:
- Lead in ginkgo pills
- Arsenic in herbals.
- Bugs in a baby’s colic and teething syrup.Other tests, reported in scientific journals, found prenatal vitamins lacking claimed
June 8, 2009
A new study from the Substance Abuse and Mental Health Services Administration (SAMHSA) finds that the prevalence of illicit drug use — and drug preferences — vary widely among the states. The SAMHSA report, drawn from data gathered by the 2006 and 2007 National Surveys on Drug Use and Heath, found, for example, that use of drugs ranges from a low of 5.2 percent in Iowa to a high of 12.5 percent in Rhode Island. However, Iowa had one of the nation’s highest rates of alcohol dependence. "This report shows that while every state faces its own unique pattern of public
June 4, 2009
FDA Releases Qtr 4 ’08 Potential Signals of Serious Risks/New Safety Information from Adverse Event Reporting System (AERS)The U.S. Food and Drug Administration (FDA) listed two dozen drugs, including weight-loss medicines and sleep disorder pills that it is at an early stage of reviewing for potential safety problems. Many of the issues have been previously disclosed, but remain under review by the Food and Drug Administration. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between
May 27, 2009
The recession is taking a toll on some American workers' health as nearly one in three (27%) survey respondents report forgoing healthcare treatment to save money on co-payments or co-insurance costs. About 20% of respondents report that they skipped taking their prescription medication dosage as prescribed by their doctor. The National Business Group on Health (NBGH) survey of 1,500 workers employed at large employers (2,000 or more employees) was conducted in March 2009. Workers in the survey ranged between 22 and 69 years of age and
May 26, 2009
DRAFT Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device PromotionThis draft guidance describes factors FDA considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C 21 Act or the Act) and relevant regulations. The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors. This guidance responds to stakeholder
May 19, 2009
Dr. Carolyn Clancy, Director of the federal Agency for Health Care Research and Quality (AHRQ), describes the evolving concept of the medical home in this advice column. A medical home takes a team approach to primary care and puts the patient at the center of that team. The idea isn't new, but it’s getting tested in new and larger ways. Medical home teams often work in a primary care doctor’s office or clinic. Team members can include doctors, nurses, pharmacists, and physical therapists. They help coordinate their patients' care across a range of
May 15, 2009
In a continuing effort to empower parents with the tools to stop medicine abuse among teens, the leading manufacturers of over-the-counter (OTC) cough medicines are adding a new educational icon on the packaging of products containing dextromethorphan. The icon will be on the majority of cough medicines containing dextromethorphan, including brand name and private label products, by the end of 2009. OTC cough medicines containing dextromethorphan can be very dangerous when intentionally abused in extreme amounts to get high. While educational efforts