News Briefs
Deadlines may affect drug safety
An analysis of decades of drug approvals, published in the New England Journal of Medicine, provides the first scientific evidence supporting complaints that medications approved on deadline by the Food and Drug Administration (FDA) are more likely to cause safety problems than drugs approved prior to a deadline date.
Deadlines were first imposed on the FDA in 1992 by a law that allowed drug makers to pay fees directly to the agency to hire more reviewers and clear a backlog of pending drug applications. In return for the fees, the FDA had to either approve or reject the drug within 12 months of the application.
A six-month deadline was in place for drugs that were so unusual or potentially lifesaving that they were classified high priority. The deadline was tightened to 10 months by Congress in 1997. Daniel Carpenter, author of the study and Harvard professor, found that drugs approved in the two months leading up to the user-fee deadline had a four- to five-fold higher rate of later being withdrawn or requiring serious safety warnings than those drugs approved faster or those that missed the deadline.
Drugs that were approved at the deadline that later caused problems were: the painkiller Vioxx, pulled off the market in 2004 for increasing the risk of heart attacks and strokes; its competitor Bextra, gone in 2005; the diabetes drug Rezulin, withdrawn in 2000 for liver problems; and cholesterol-lowering Baycol pulled in 2001 for muscle damage.
More recently, the diabetes blockbuster Avandia was linked to heart risks last year, getting a strict new warning label.
Reference
1. Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. NEJM 2008; 358:1354-1361.
AHRQ offers help to patients on tracking medications
If your patients are having difficulty remembering which prescriptions to take and when to take them, the Agency for Healthcare Research and Quality now has an easy solution: a free on-line "pill card." According to the AHRQ, using a "cheat sheet" like the pill card reduces misunderstandings that can help improve patient adherence to provider's instructions. To view instructions on how to create a pill card for your patients, please go to: http://www.ahrq.gov/qual/pillcard/pillcard.htm.
An analysis of decades of drug approvals, published in the New England Journal of Medicine, provides the first scientific evidence supporting complaints that medications approved on deadline by the Food and Drug Administration (FDA) are more likely to cause safety problems than drugs approved prior to a deadline date.Subscribe Now for Access
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