Company pulls pain drug from market

After reviewing safety data on a range of anti-inflammatory drugs, the Food and Drug Administration on April 7 asked Pfizer to remove its prescription pain medication valdecoxib (Bextra) from the market. The New York City–based pharmaceutical firm subsequently ceased selling the drug both in the United States and in the European Union.

Known as a COX-2 inhibitor, Bextra belongs to the same class of drugs as rofecoxib (Vioxx), which manufacturer Merck yanked from pharmacy shelves last September after safety risks appeared (SN: 10/30/04, p. 286: Available to subscribers at COX-2 inhibitor pulled off market.).

FDA also asked Pfizer and other companies to highlight safety warnings in the package inserts that are distributed with certain other nonsteroidal anti-inflammatory drugs, or NSAIDs. Recent studies have linked long-term use of these drugs with cardiovascular risks. Some can also cause gastrointestinal damage or skin reactions. The drugs include another COX-2 inhibitor, Pfizer’s celecoxib (Celebrex), numerous prescription NSAIDs, and over-the-counter NSAIDs such as ibuprofen and naproxen. The labeling change does not apply to the painkillers aspirin and acetaminophen.