| Pfizer Halts Bextra Sales in U.S., Europe
Thu Apr 7, 2005
By Toni Clarke
NEW YORK (Reuters) - Pfizer Inc. on Thursday agreed to suspend sales of its arthritis drug Bextra after U.S. and European regulators said the risk of serious side effects, including a potentially fatal skin allergy, outweigh the benefits.
The U.S. Food and Drug Administration also asked Pfizer to add a black box warning -- the strongest possible -- to the label for its painkiller Celebrex. Bextra and Celebrex belong to a class of drugs known as COX-2 inhibitors that also includes Merck & Co.'s Vioxx, which was withdrawn last year because of an increased risk of stroke and heart attack.
The agency also asked the makers of dozens of other prescription and non-prescription painkillers, including Motrin, Advil and Aleve, to strengthen warnings about possible heart risks and potentially life-threatening gastrointestinal bleeding. The new warnings do not apply to aspirin.
Motrin and Aleve, which are versions of ibuprofen, are members of a class of drugs known as non-steroidal anti-inflammatory drugs, or NSAIDs. Bextra, Celebrex and Vioxx are selective NSAIDs designed to reduce the risk of gastro-intestinal bleeding.
The FDA said it singled out Bextra for suspension because it gives no added advantage as a painkiller and can cause a potentially life-threatening skin condition called Stevens-Johnson syndrome, an allergic reaction that usually begins as a blistering of the mouth and lips and can spread to the rest of the body.
Canada also asked Pfizer to suspend sales of Bextra. Pfizer said it disagrees with the regulatory decisions on Bextra, which had sales in 2004 of $1.3 billion, and will explore options with regulators under which it might be allowed to resume sales of the drug.
The suspension is the latest in a long series of actions by companies, regulators, advisers, lawyers and consumers that began last September when Merck withdrew Vioxx after a clinical trial showed it doubled the risk of heart attack and stroke in patients who took it for more than 18 months.
Pfizer's shares fell just 1.4 percent, however, as investors bet that sales of Celebrex -- which had sales of $3.3 billion in 2004 -- would be shored up by the request for warnings on other drugs.
"Bextra being suspended is certainly a negative but this is largely balanced out by the leveling of the playing field," said Albert Rauch, an analyst at A.G. Edwards & Sons. "Now they're all being painted with the same brush."
Sales of Pfizer's COX-2 inhibitors have slowed since December, when the FDA called on doctors to limit prescribing Celebrex and Bextra in light of evidence that they also may increase the risk of heart attack and stroke.
Some doctors were concerned about latest Bextra decision.
"It's confusing to me and a little disappointing that as a physician I can't take the responsibility to talk it over with my patients," said Dr. Stephen Lindsay, head of rheumatology at Ochsner Clinic Foundation in Baton Rouge, Louisiana.
The FDA said that it is willing to "carefully review" any proposal by Merck to reintroduce Vioxx, reflecting the assessment of an advisory panel which in February concluded that Vioxx, Bextra and Celebrex all posed some level of heart risk but that Vioxx was safe enough to return to the U.S. market. All three drugs should have a black box warning, they said.
Analysts think Vioxx would have an uphill battle competing with Vioxx if it did manage to return to the market, but it could limit Merck's litigation liability. The company has been sued by thousands of patients who claim they were hurt by the drug.
Shares of Pfizer, which in December hit a four-year low of $23.52, fell 38 cents to $26.49 in early afternoon trading on the New York Stock Exchange, while Merck was little changed.
"We continue to believe that Celebrex is a good drug for Pfizer and will help drive numbers, just not at the levels we would have hoped for 18 months ago," said Jason Fox, an analyst at H&R Block Financial Advisors.
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