The Food and Drug Administration has this month begun to issue a quarterly report of potential safety issues. The report lists drugs that are being evaluated for potential safety issues, drugs that have been identified by reviewing reports in the FDA’s Adverse Event Reporting System (AERS). The Food and Drug Administration Amendments Act, passed into law in September 2007, requires the FDA to issue the report.
The report lists 20 drugs and the potential risk associated with that drug. There is no indication of how widespread or serious the problem may be. This bothers some that it may cause some patients to stop taking their medications and therefore perhaps create another health risk for themselves.
“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,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.
The Pharmaceutical Research and Manufacturers of America, the main industry lobbying group, said it supports giving more safety information to doctors and patients, but worries that some will be needlessly alarmed.
“Our reservation is that patients will be abruptly stopping therapy,” said Alan Goldhammer, a vice president of the organization. “One can’t generalize with an emerging safety notice. It may affect half the patients, a quarter of the patients, or only a small subset of the patients.”
The report, January-March 2008: http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm
Jim
Dave