Pfizer Agrees to Suspend Sales of Bextra
Thu Apr 7, 5:18 PM ET
NEW YORK (Reuters) - Pfizer Inc. 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 of 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and Celebrex belong to a class of drugs known as COX-2 inhibitors that also includes Merck & Co.'s Vioxx, which was withdrawn last year because of an increased risk of stroke and heart attack.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 suspension, which threatens Pfizer's top-flight credit rating, is the latest setback for the class of drugs that began last September when Merck withdrew Vioxx after it showed increased risk of heart attack and stroke in patients who took it for more than 18 months.
The FDA also asked the makers of dozens of other prescription and nonprescription 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 Advil, 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 gastrointestinal 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 to the rest of the body.
The Bextra decision surprised analysts because an FDA advisory panel in February voted to keep Bextra on the market, and the FDA usually follows the advice of its advisory panels. But investors bet that Celebrex, which had sales of $3.3 billion in 2004, would be shored up by the request for warnings on other drugs, and Pfizer's stock closed little changed at $26.90. It hit a four-year low in December.
"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."
Pfizer said it disagrees with the regulatory decisions on Bextra, which include a request from Canada to suspend the drug. The company said it would explore options with regulators under which it might be allowed to resume sales of the drug, which amounted to $1.3 billion in 2004.
Still, Moody's Investors Service said it may cut Pfizer's "triple-A" senior debt rating. Only seven U.S. companies have this rating from Moody's and Standard & Poor's, including Johnson & Johnson, General Electric Co. and Exxon Mobil Corp.. Merck lost its triple-A rating last year after its problems with Vioxx.
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.
The FDA said it was willing to "carefully review" any proposal by Merck to reintroduce Vioxx, reflecting the assessment of the advisory panel which 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, the panel said.
Analysts think Vioxx would have an uphill battle competing with Celebrex if it did manage to return to the market, but such a move could help limit Merck's litigation liability. The company has been sued by thousands of patients who claim they were hurt by the drug. Now Pfizer is expected to be faced with similar suits.
"There will be a stampede of lawsuits," said Matt Zapf, head of product liability at the Chicago law firm of Goldberg Kohn.
Merck's shares rose 60 cents, or 1.8 percent, to $33.49 on the New York Stock Exchange.
"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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