While those headlines in March may have left consumers worrying which drugs in their medicine cabinets might be next, the Food and Drug Administration says people should not be alarmed. The pace of drug withdrawals has been constant for decades, the FDA says. Since 1979, between 1 percent and 3.5 percent of the dozens of new drugs approved each year have been recalled. Critics call that unacceptable, saying the agency has unnecessarily put millions of people at risk of serious side effects. But the FDA says withdrawing drugs is necessary and does not view it as a failure or an admission of a mistake.
All drugs have side effects, and rare ones are unlikely to show up in clinical trials.
They appear only after a drug hits the market and millions of people take it. Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said a small number of recalls are inevitable, especially as new, safer alternatives come along. Woodcock said in an interview. Such was the case with Warner-Lambert Co.'s Rezulin, the diabetes drug that was linked to 63 deaths from liver failure. FDA officials asked for its withdrawal once they determined that two newer drugs worked just as well with fewer safety risks, Woodcock said.