The Food and Drug Administration issued a far-reaching warning today on a large class of pain relievers and requested a voluntary recall of Bextra, a commonly used drug from this class. The FDA said that the class of pain relievers, called nonsteroidal anti-inflammatory drugs (NSAIDs), which includes the nonprescription medications ibuprofen and naproxen (Aleve), could increase a person's risk of cardiovascular problems or gastrointestinal bleeding. This is the first time the agency has issued such a warning for this class of drugs, which are used by millions of people around the country to relieve everything from arthritis to menstrual cramps.
"We think these risks apply to all of the drugs" in this class, said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research. He said that although future research may make it possible to rank the drugs in this class by safety, existing studies compel the agency to issue a warning about the entire class. Galson did say that taking low doses of the drugs over a short period of time, such as two weeks or less, did not seem to increase the risk of adverse health effects.
Bextra, which is manufactured by Pfizer, belongs to a special class of NSAIDs called Cox-2 inhibitors. The FDA based its decision on studies showing that Bextra puts patients at greater risk of several potentially fatal skin conditions than if they take other Cox-2 inhibitors, and do not receive greater benefits. Pfizer said it had heard last night that the FDA would ask that the drug be withdrawn, and though the company disagreed with the FDA's decision, it did comply. The re-examination of Cox-2 inhibitors was sparked last fall when Merck pulled Vioxx from the market because of an increased risk of cardiovascular events.
With the removal of Bextra, Celebrex remains the only Cox-2 inhibitor on the market. That drug and all other NSAIDs will receive a black box warning, the FDA's strongest, describing the risks involved in taking the drug. In addition, the FDA will require Pfizer, the maker of Celebrex, to evaluate the risks of the drug with a new long-term study.
Over-the-counter products that include NSAIDs will stay on the shelves but will get different labels. While Galson said in a morning press conference that these nonprescription drugs are safe for consumers who take them as directed on the bottle, manufacturers of over-the-counter NSAIDs such as ibuprofen and naproxen will need to revise their labels. The new labels will include information on the potential cardiovascular and intestinal risks as well as the possibility of rare but sometimes fatal skin reactions that can occur when taking the drugs. The agency pointed out that the new warning does not apply to aspirin.