FDA Unaware of Most Drug Complaints; Doctors Not Required to Report Adverse Side Effects

Article excerpt

Byline: Joyce Howard Price, THE WASHINGTON TIMES

The Food and Drug Administration receives more than 300,000 reports annually about adverse effects caused by drugs on the market, but officials say those reports don't include most patients' concerns because local health care professionals are not required to report complaints to the federal level.

"We've always estimated we get about 10 percent of all reports," said Dr. Paul Seligman, director of the FDA's Office of Pharmacoepidemiolgy and Statistical Science.

A Harvard study two years ago, published in the Journal of the American Medical Association, cited previous research that estimated only 10 percent of serious adverse effects are given to the FDA through its MedWatch program.

MedWatch is the voluntary system the FDA established in 1993 for health professionals to report serious adverse reactions and problems related to drugs, biologics, medical devices, dietary supplements, cosmetics and infant formulas. MedWatch followed another FDA voluntary-reporting program started in 1961.

Pharmaceutical firms are required to report adverse effects to the FDA.

"Ninety percent of the reports we receive about the most adverse effects come from manufacturers," said Dr. Seligman, noting that many doctors and pharmacists first report such complaints to manufacturers.

Dr. Gregory A. Thompson, director of the Los Angeles County-University of Southern California Drug Information Center, which advises health care professionals about proper dosages and side effects of medications, said the proportion of serious drug complications voluntarily reported to the FDA is "far lower" than 10 percent. …