Pfizer Inc. reluctantly halted sales of its arthritis painkiller Bextra yesterday after the Food and Drug Administration concluded that the drug posed too many serious safety risks. It was the second major arthritis medication to be withdrawn in the past six months.
In addition to asking Pfizer to stop selling its $1.4 billion-a-year blockbuster, the FDA concluded that the entire class of anti-inflammatory painkillers carries a potentially increased risk of heart attack and stroke -- and it told manufacturers to substantially toughen the safety warnings on almost all nonnarcotic painkillers still on the market.
Prescription painkillers such as Celebrex and Mobic will remain available, but with the strongest safety warnings the FDA can require. The makers of nonprescription pain relievers such as Motrin and Aleve will be required to tell consumers more about their risks -- warning them to take the pills only for the short periods recommended on the labels, usually no more than two weeks.
For millions of pain sufferers, especially people with chronic arthritis, the FDA action was the latest twist in six months of misfortune that began with Merck & Co.'s withdrawal of the popular painkiller Vioxx. Drugs such as Vioxx, Celebrex and Bextra, hailed not long ago as near-miracle therapies, are now either gone or under a cloud, along with dozens of other anti-inflammatory drugs.
"Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, said in a statement. "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs."
Yesterday's actions were among the most sweeping ever initiated by the FDA, which has traditionally been reluctant to take drugs off the market and cautious about branding an entire class of drugs as worrisome. Since 1997, the agency has sought the withdrawal of 13 drugs.
The FDA went beyond the recommendations of a 32-member panel of expert advisers that it brought together in February for a three-day public hearing about all nonnarcotic painkillers. That panel narrowly recommended that Bextra should be allowed to remain available and that Vioxx should be allowed back on the market under certain conditions. Galson said that, because the expert panel's votes were so close, the agency believed its actions are consistent with the recommendations.
Alastair J. Wood of Vanderbilt University, the chairman of that committee, applauded the FDA yesterday for "asserting itself and taking a strong stand."
"When a bare minority votes to keep a drug on the market, that's not a safety endorsement -- it's a devastating indictment," Wood said. "The FDA saw that and responded."
By taking Bextra off the market and requiring serious warnings on all other medications in the class known as non-steroidal anti-inflammatory drugs (NSAIDs), the agency will significantly affect the lives of tens of millions of patients in pain who use them. The only major nonnarcotic painkillers not included in the warning are aspirin and acetaminophen (widely sold as Tylenol), which are not NSAIDs but carry different risks of their own.