Potential drug problem reports, from the November/December issue of Positively Aware Options

[Root Admin]

The FDA in September kicked off a new report for consumers based on its Adverse Events Reporting System (AERS). The new quarterly report, titled “Potential Signals of Serious Risks/New Safety Information,” is a result of recent federal legislation directing the FDA to make such concerns more public. The AERS database contains millions of reports of adverse events submitted to the FDA by drug makers, health care providers, and patients. According to a press release from the FDA, “The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.” The FDA also quoted the director of its Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., as saying, “My message to patients is this: Don’t stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.” Because the potential risk is so preliminary, the information provided is solely the name of the product and the possible side effect. For example, one HIV drug made the first list in September. The only information given was “Intelence (etravirine), hemathrosis.” (See page 39 for more information on this issue.)

Patients can report serious adverse events or quality problems to www.fda.gov/medwatch. If you do not have Internet access, you can call a number for your state to report serious reactions. Each state has a different number to call. In Illinois, that number is (312) 353-7840. See the entire list of state numbers at http://www.fda.gov/opacom/backgrounders/complain.html. A toll-free service to call U.S. government agencies from TTY devices is available from Federal Relay Services, 1-800-877-8339. The FDA also makes a specific HIV drug update available, and people can sign up for this e-mail list. Go to http://www.fda.gov/oashi/aids/listserve/archive.html and select “join this list.”