Adverse Drug Reactions Seen after Approval in 10% of Drugs. (FDA Standards Questioned)

Article excerpt

Serious adverse drug reactions were noted after marketing in more than 10% of 548 drugs approved between 1975 and 1999, according to Dr. Karen E. Lasser of Harvard Medical School, Boston, and her associates.

These drugs eventually acquired at least one black box warning for serious adverse drug reactions (ADRs) or were withdrawn from the market for safety reasons that were not recognized at the time of Food and Drug Administration approval, the investigators said.

The investigation included all prescription drugs considered to be new molecular entities during the 25-year period. A manual search of the Physicians' Desk Reference (1975-2000) determined the proportion of new drugs that acquired new black box warnings or that were withdrawn from the market. The findings led investigators to recommend that new drugs that do not represent a significant advance over existing therapies be considered second-line treatments until their safety is better known.

The investigators also advised the FDA to raise the threshold for approving new drugs when safe, effective therapies already exist and when a new drug treats a benign condition. New drugs that significantly reduce morbidity and mortality may warrant use despite limited experience with these drugs and the potential for ADRs in the postmarketing period (JAMA 287[17]:2215-20, 2002).

In an accompanying editorial, Dr. Robert J. …