The Food and Drug Administration said Thursday it is requiring Pfizer Inc. to pull its painkiller Bextra off the U.S. market.
The FDA will also require the company's drug, Celebrex, to carry a "black box" warning about increased cardiovascular risks. The boxed warning is the strongest available to the FDA.
The agency didn't announce a decision on the return of Merck & Co.'s Vioxx to the market, only saying it would carefully entertain any proposals from the company to bring it back.
The FDA said Pfizer, New York, agreed to suspend U.S. sales and marketing of Bextra "pending further discussions with the agency."
Bextra sales totaled $1.3 billion last year, and Celebrex sales totaled $3.3 billion.
In a statement, Pfizer said it "respectfully disagreed" with the FDA's decision on Bextra. The company also said it would suspend Bextra's sales in the European Union at the request of European regulators. Pfizer said it will explore options with the FDA to see if Bextra can eventually be returned to the U.S. market. Shares of Pfizer were down 95 cents, or 3.5%, to $25.91 in morning trading on the New York Stock Exchange.
The FDA also said it will require various manufacturers of both prescription and over-the-counter painkillers known as nonsteroidal anti-inflammatories to change their labels to discuss the potential for cardiovascular and gastrointestinal problems.
Manufacturers of prescription-strength NSAIDs will also be required to carry a black-box warning, which is the toughest warning a drug can carry. Patients receiving prescription NSAIDS will also be given a medication guide that further discusses adverse risks. Over-the-counter makers of NSAIDS, such as ibuprofen, will also be required to include information about possible skin reactions from using such drugs.
Pfizer said the FDA, in seeking Bextra's withdrawal, cited a risk of serious skin reactions to Bextra on top of the risks shared by other similar drugs.
The FDA started examining safety data for a range of painkillers after Merck pulled Vioxx from the market last September following a clinical trial that showed it doubled the risk of heart attacks and strokes among certain people using the drug for 18 months or longer.
In a statement Thursday, Merck, of Whitehouse Station, N.J., said it looked "forward to discussions with the FDA," but didn't specifically say whether the company would ask the FDA to allow Vioxx to return to the market.
The agency convened a panel of outside experts to discuss Celebrex, Vioxx and Bextra-all known as Cox-2 inhibitors-as well as NSAIDS, after a couple of studies suggested those drugs might also increase the risk for cardiovascular problems like heart attacks and strokes. The panel narrowly voted to suggest that the withdrawn Vioxx be allowed back on the market in limited circumstances. They also narrowly voted to recommend that Bextra stay on the market and were almost unanimous in a recommendation to keep Celebrex on the market. Many panel members were concerned about the lack of long-term safety data about Bextra, which was the newest of the Cox-2 drugs.
"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Steven K. Galson, the acting director of FDA's Center for Drug Evaluation and Research. "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."
Celebrex, Bextra and Vioxx were primarily designed to treat chronic pain caused by arthritis and other ailments. They are meant to be easier on the stomach than NSAIDs like ibuprofen. They stop the Cox-2 enzyme, which is thought to be responsible for the pain and swelling of arthritis. Painkillers such as ibuprofen also reduce the Cox-2 enzyme, but they also block another enzyme, Cox-1, which is related to stomach functions.
Acknowledging that growth this year is sputtering to a halt, Pfizer said Tuesday it would seek cost cuts of $4 billion, twice as deep as some analysts had expected. (See the transcript of the analyst meeting, provided by Thomson StreetEvents.) The company has seen sales decline sharply for Celebrex and Bextra arthritis pills because of safety worries, and for epilepsy and pain medicine Neurontin, which lost patent protection. Pfizer said it was notified of the FDA's decisions on Bextra and Celebrex after the market closed Wednesday.