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April 7, 2005 9:58 a.m. EDT
FDA Asks Pfizer to Withdraw
A WALL STREET JOURNAL ONLINE NEWS ROUNDUP
WASHINGTON -- The government has asked Pfizer Inc. to withdraw the painkiller Bextra from the market and include the strongest safety warning on Celebrex.
The Food and Drug Administration said today it is requiring Pfizer to pull its painkiller Bextra off the U.S. market because it increases the risk of heart attack and stroke. The FDA also called for the company's drug, Celebrex, to carry a "black box" warning about increased cardiovascular risks. Pfizer will also suspend Bextra sales in Europe after European Union regulators raised similar concerns about the drug.
Pfizer said it disagrees with the FDA's position on Bextra but it agreed to suspend sales of the drug. The company said it is "evaluating the operational and financial impact of these actions." Shares of Pfizer were down 95 cents, or 3.5%, to $25.91 in morning trading on the New York Stock Exchange.
The FDA didn't announce a decision on the return of Merck & Co.'s Vioxx to the market, only saying it would carefully consider any proposals from the company to bring it back.
The announcement comes just days after Pfizer sharply scaled back earnings estimates and announced a sweeping restructuring.
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. 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.
Pfizer said Tuesday it is undertaking an ambitious program of cost-cutting and restructuring that stretches from the factories that produce pills to the armies of sales representatives who call on doctors. Pfizer said at the time that the changes would allow it to return to double-digit earnings growth in 2006. It estimated that the cost of the restructuring would be $5 billion to $6 billion through 2008.
The FDA has been studying the safety of the so-called Cox-2 inhibiters since Merck voluntarily pulled Vioxx from the market Sept. 30 after heart problems were reported in some users.
Revisions to Labels
In addition to the prescription drugs, the FDA asked manufacturers of over-the-counter nonsteroidal anti-inflammatory drugs, or NSAIDS, to revise their labels to include information about the risks of cardiovascular incident and gastrointestinal bleeding. Over-the-counter makers of NSAIDS like ibuprofen will also be required to include information about possible skin reactions from using such drugs.
In February, advisers to the FDA had recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to contiue to use them despite the health risks. The panel said Vioxx posed the greatest risk and that Celebrex had the fewest side effects.
The FDA said Pfizer agreed to suspend U.S. sales and marketing of Bextra "pending further discussions with the agency."
The FDA started examining safety data for a range of painkillers after Merck pulled Vioxx from the market last September after a clinical trial showed it doubled the risk of heart attacks and strokes among people using the drug for 18 months or longer.
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 were designed 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 reduce the Cox-2 enzyme, but they also block another enzyme, Cox-1, which is related to stomach functioning.
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