While federal regulators forced Pfizer Inc. to pull a billion-dollar prescription pain reliever from the market, the embattled drug firm also won a victory: It can continue selling its blockbuster painkiller Celebrex.
For the time being, Celebrex will be the only COX-2 inhibitor category of painkiller on the market, following Merck & Co.'s voluntary withdrawal of Vioxx in September and the Food and Drug Administration's order that Pfizer pull Bextra off pharmacy shelves. COX-2 inhibitors were widely prescribed and heavily advertised painkillers, popular because they did not cause gastrointestinal side effects. They've come under increasing scrutiny because of a link with heart disease and stroke.
"This is almost a break-even situation," said Albert L. Rauch, an A.G. Edwards & Sons Inc. analyst, noting Bextra accounted for just $1.2 billion of Pfizer's $52 billion in sales last year. "It's minimally negative."
And not surprisingly, he said, the market did not penalize Pfizer the way it punished Merck in September. When Merck pulled Vioxx off the market, shares plunged 27 percent, erasing more than $26 billion in market value.
Shares of Pfizer actually rose 4 cents yesterday, closing at $26.90. But that's about $10 less than a year ago, as concerns about the firm's sagging pipeline of new drugs have bruised the stock.
Though Celebrex, which netted $3.3 billion in sales last year, can stay on the market, the FDA is requiring that it carry the strongest possible warning -- in a black box -- of cardiovascular risks.
The FDA said it will also require stronger warnings about heart and other risks for all similar anti-inflammatories, including over-the-counter drugs such as Advil, Motrin and Aleve, which many patients were advised to switch to following concerns about COX-2 inhibitors.
Tylenol and aspirin will now be the only pain relievers without the warnings.
Analysts said broader warnings for anti-inflammatory drugs may actually help Celebrex sales increase.
"The news surrounding the labeling of the older drugs is sort of positive when you are comparing therapies because there was previously a view that those older drugs were safer," said Barbara Ryan, an analyst for Deutsche Bank.
