FDA urges limits on Celebrex, Bextra
WASHINGTON (CNN) -- The Food and Drug Administration issued a public health advisory Thursday, recommending doctors limit the use of Pfizer Inc.'s Celebrex and Bextra to patients who can't take other pain medicines.
Last week, Pfizer announced a clinical trial indicates arthritis painkiller Celebrex could carry an increased risk of heart attacks and strokes. In September, Merck & Co. Inc. pulled its pain reliever Vioxx from the market for similar reasons. Pfizer hasn't pulled Celebrex.
This week, another clinical trial found the over-the-counter medicine naproxen also increased the risk of heart attack and stroke.
The FDA said that it is reviewing the studies before deciding what action to take and that in the meantime doctors should use over-the-counter pain relievers such as ibuprofen and aspirin for as many patients as possible.
The agency advised reserving Celebrex and Bextra, the class of drugs known as Cox-2 inhibitors, for patients with a history of gastrointestinal bleeding, or for those who found no relief from the other drugs.
The health advisory also stressed that doctors should evaluate patients for a history of heart disease before prescribing a Cox-2 inhibitor.
The FDA said it is planning a February meeting to review the products.
In response, Pfizer didn't directly address the recommendation to limit the use of the drugs. The company said it is providing the FDA and other world regulatory agencies with data on Celebrex and Bextra and that patients should consult their doctors about appropriate medication.
"The U.S. FDA advisory committee hearing in February is the appropriate forum for a thorough review of all available data evaluating the benefits and risks of medicines used by millions of Americans to treat arthritis and joint pain," Pfizer said in a statement.
Critics of the FDA said the advisory's suggestion that Celebrex and Bextra protect the stomach from bleeding is misleading.
Dr. Sidney Wolfe of the consumer advocacy group Public Citizen said that although the agency found evidence that Vioxx wasn't linked to bleeding, "there is no such credible evidence for either Celebrex or Bextra."
The FDA said that six-month studies found such protection in Celebrex, but by 12 months that benefit was gone.
"Both Celebrex and Bextra are doomed drugs that are in the twilight of their existence," Wolfe said. "Breathing extra life into them is surely beneficial to Pfizer executives and stockholders but is a step backward for an agency that is supposed to be part of the Public Health Service."
In the meantime, the FDA is evaluating dozens of clinical trials using Celebrex or Bextra, and has warned that anyone taking over-the-counter medicines longer than labels recommend should contact their physicians. For naproxen, the agency advises patients take no more than 220 milligrams twice a day and for no longer than 10 days.
Aspirin is the only over-the-counter pain reliever that studies have shown protects the heart. But it also has the greatest risk of causing potentially fatal gastrointestinal bleeding, so the FDA said patients should consult their doctors before taking it over the long term.
