NSAID and CCB both withdrawn within days

FDA's move shines spotlight on agency's decisions

The Food and Drug Administration pulled Duract (bromfenac), a nonsteroidal anti-inflammatory drug (NSAID), off pharmacy shelves on June 22, close on the heels of Palo Alto, CA-based Roche Laboratories' voluntary withdrawal of Posicor, its blood pressure medication. Duract, manufactured by Wyeth-Ayerst Laboratories of St. Davids, PA, has caused a dozen cases of serious liver failure since it went on the market last July - four patients died and eight required liver transplants. All cases involved patients who took the drug for longer than the recommended 10 days. Both the agency and the company are advising patients who have been taking Duract for longer than 10 days to stop immediately, and all patients who are using the medication should consult their doctors.

FDA's rapid drug approvals questioned

Roche's calcium channel blocker Posicor (mibefradil) was withdrawn because it proved to be potentially lethal when used in combination with certain other drugs. Duract and Posicor both treat disorders for which there are already plenty of approved therapies, leaving critics to wonder why they are allowed on the market in the first place. The FDA's move renewed questions about whether the agency's new emphasis on speeding up drug approvals is allowing unsafe medicines to reach patients. In recent years, the agency has been under intense pressure from Congress to speed up its drug approval process, and 92 new products have been released over the past two years. Proponents of the fast-track system argue that it is necessary to bring life-saving therapies to patients who desperately need them.

The review of Duract took nearly three years and was extremely thorough, say FDA proponents. Although the agency was aware of the potential for liver problems with long-term use, it made a calculated decision to approve the drug for short-term use, no more than 10 days, because the benefits outweighed the risks. Patients typically take NSAIDs for weeks or months at a time, which may explain why doctors continued to prescribe Duract for long times.