The world's largest drug maker suspended sales of the popular pain reliever Bextra and agreed to put a stricter warning on Celebrex, the only similar pain reliever still available to arthritis sufferers.
Pfizer's decision came at the urging of regulators in the United States and Europe who determined the risks associated with Bextra, like Vioxx before it, are not worth the benefits.
In addition to increasing the risk of a heart attack, Bextra has been known to cause blisters of the skin and mucous membranes, skin lesions, flu-like symptoms, high fevers, severe peeling of deadened skin, acute eye irritation, blistering and erosion and, in some cases, death.
Even so, removal of the drug was "another huge blow" to arthritis sufferers, said Lisa Fall, president of the Utah-Idaho Arthritis Foundation. More than 71 million Americans have the painful condition - in Utah, it's one out of three adults - and Pfizer's decision further limits their treatment options.
But it was hardly surprising, Fall said. Ever since Merck removed Vioxx from pharmacies in September, doctors have been more cautious about prescribing the super-painkillers known as COX-2 inhibitors. The COX-2 drugs were seen as better treatments for persistent pain because they were less likely to cause stomach bleeding than common drugs such as naproxen and ibuprofen.
After Vioxx was removed from the market, the Veterans Administration Hospital in Salt Lake City also stopped its doctors from prescribing Bextra and Celebrex to veterans, although Celebrex might become available again, said hospital rheumatologist Grant Cannon.
It's a trade-off, said Cannon. Celebrex is less effective at preventing bleeding ulcers, but it causes fewer heart attacks.
"It's like choosing between North Carolina and Illinois in the NCAA Tournament," Cannon said. "It's not that Celebrex is better than Bextra. It just won the championship game."
Not that anyone is cuing the song "One Shining Moment" in the wake of Thursday's announcement, especially not Pfizer.
Bextra generated $1.29 billion, or 2.4 percent, of the company's revenue last year. Its withdrawal from drugstore shelves comes on top of an already gloomy outlook for the Manhattan, N.Y.-based pharmaceutical company, which announced $4 billion in cost-cutting measures earlier this week.
Pfizer said it disagreed with the FDA's finding and will work with the agency to try to resume Bextra sales. In the meantime, the company advised patients to stop taking it.
Pfizer Chief Executive Hank McKinnell was quick and persistent in defending the company's pain drugs after the Vioxx withdrawal. Bextra was linked to an elevated risk of blood clots, heart attacks and strokes in cardiac-surgery patients, resulting in the Dec. 9 addition of a safety warning to its label. The company disclosed Dec. 17 that a study linked Celebrex to elevated heart risks.
Since then, new prescriptions for Celebrex have fallen about 58 percent, according to data from Yardley, Pa.-based Verispan, which tracks more than 50 percent of all U.S. pharmacy prescriptions. Celebrex was the world's best-selling arthritis medication last year.
New Bextra prescriptions have dropped more than 80 percent since the beginning of October. Celebrex has been prescribed to more than 27 million Americans since 1999, and more than 7 million have used Bextra worldwide since 2002. In 2003, Bextra was listed second behind the allergy medication Clarinex as the most popular new drugs in Utah.
The FDA said it also will require stronger warnings about heart and other risks for Advil, Motrin, Aleve and other nonsteroidal, anti-inflammatory drugs that many patients were advised to switch to when concerns arose about COX-2 inhibitors.
Tylenol and aspirin now will be the only pain relievers without the warnings.
"Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," said a statement from Steven K. Galson, acting director of the FDA's Center for Drug Evaluation and Research.
However, Sidney Wolfe, director of the nonprofit Public Citizen Health Research Group in Washington, criticized the FDA for not removing Celebrex from the market along with Bextra. Wolfe's group asked the FDA in January to remove Bextra and Celebrex from the market.
"Further danger occurs when the FDA says it will leave Celebrex on the market," Wolfe said.
The FDA ruling went against the recommendations of its own advisory panel, which voted in February to keep Bextra on the market. According to The New York Times, 10 panel members had ties to the pharmaceutical industry. The same panel recommended Vioxx be returned to the market, but that has not happened.
The FDA said Thursday it ''will carefully review any proposal from Merck for resumption of marketing of Vioxx.''
But the real trick will be deciding how to evaluate the other two COX-2 drugs in the pipeline, said Cannon, who also is on staff at the University of Utah Hospital.
"The Vioxx study had 2,500 patients," Cannon said. "If they make [the drug makers] do that study before they release these other drugs, they'll never be able to afford it."
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Tribune wire services contributed to this story.


