FDA unveils list of medications with potential safety problems.
The Washington Post (9/6, A2, Brown) reported, "The Food and Drug Administration (FDA) will begin posting every three months a list of" medications "whose safety is under investigation because of complaints brought to the agency's attention by" pharmaceutical "companies, physicians, and patients." On the list, the medication "and the nature of the 'adverse events'" will be named, but the agency "will not describe their seriousness, or the number of complaints received." The Post also pointed out that "being on the list does not mean the" medication "is unsafe, only that the FDA is looking into that possibility."
The Wall Street Journal (9/6, A4, Favole, Wang) added that "the list includes a wide array of" medications, including the antidepressant Cymbalta (duloxetine). The agency "has already sent out warnings about a handful of the" medications "on the list. ... But, there appear to be new ones, too." Now, the FDA plans to notify "companies whose" medications "appeared on the list prior to it being made public." And, while pharmaceutical companies said that "they support the FDA's additional efforts to be transparent about" medication safety, they "expressed concern that the information was being communicated to patients without context, and wondered about what patients might do with the information."
The AP (9/6, Alonso-Zaldivar) echoed that sentiment, noting that "consumer advocates called the listing a positive step, but said it needs to be fleshed out." Thomas J. Moore, of the Institute for Safe Medication Practices, said that the list "needs to have much more detail if it's to have significant safety value."
"This information is being posted as part of the 2007 Food and Drug Administration Amendments Act," according to HealthDay (9/5, Reinberg). "Under the act, the agency must post quarterly information on potential" medication "risks, based on the agency's review of adverse-event reports submitted by doctors." The list will only contain medications from the "issues identified in the adverse-event reporting system." But, it "will not include all the" medications "the FDA is currently reviewing for safety problems," said Gerald Dal Pan, M.D., M.P.H., director of the FDA's Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research. The first list, which was released last week, only includes" medications "from the first quarter of this year. Medications "under investigation before 2008, or after March, aren't included."
The Los Angeles Times's (9/6, Roan) Booster Shots blog quoted Janet Woodcock, M.D., of the FDA's Center for Drug Evaluation and Research, as saying, "My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a" medication "that appears on this list, you should continue taking it, unless your doctor advises you differently."
Modern Healthcare (9/6, DerGurahian), UPI (9/6), AHN (9/6, Sharma), and WebMD (9/5, DeNoon) also covered the story. The AP (9/6) also published the complete list of medications released by the FDA, including "Seroquel (quetiapine), for bipolar disorder."
