View Full Version : Pfizer Suspends Sales of Bextra at F.D.A.'s Request


Andi
04-13-05, 01:45 PM
By JENNIFER BAYOT

Pfizer Inc. agreed today to suspend sales of its painkiller Bextra at the request of the Food and Drug Administration, which also said it was instructingdrug makers to better warn patients of the health risks of other widely used medications like it. In asking for Bextra's withdrawal, the F.D.A. said that the drug could in rare cases cause a fatal skin reaction and, like other drugs in its class, lacked the benefit of long-term study and could put bypass surgery patients at greater risk of heart attacks and strokes.

But such side effects were already well publicized, and an advisory panel of doctors convened by the F.D.A. earlier this year had narrowly voted to keep Bextra on the market.

The F.D.A. did not immediately say whether any new information about side effects had led to its request for Bextra's withdrawal. The agency said its recommendations "are based on the available scientific data, including data accumulated since the drugs were approved."Pfizer said it disagreed with the government's position on the overall risks from Bextra, which is used to treat arthritis and other chronic conditions. But it agreed to cease selling or marketing Bextra pending talks with the F.D.A. and added that patients should stop taking the drug.

The company also said it was temporarily withdrawing the drug from Europe at the request of regulators there.

In a news release and public health advisory on its Web site, the F.D.A. also announced new rules aimed at the marketing of not only cox-2 inhibitors like Bextra and Celebrex, another Pfizer drug, but also older over-the-counter pain relievers like ibuprofen and naproxen.

A boxed warning on a drug's label and an enclosed medication guide should highlight the potentially greater risk of "cardiovascular events," like heart attacks and strokes, and gastrointestinal bleeding associated with taking the drug, the F.D.A. said

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," Dr. Steven K. Galson, acting director of the F.D.A.'s Center for Drug Evaluation and Research, said in a statement.

A list of the medications involved, known as non-steroidal anti-inflammatory drugs, or N.S.A.I.D.'s, is available on the F.D.A.'s Web site at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.

The agency's re-examination of drugs like Bextra began after Merckvoluntarily withdrew a similar painkiller, Vioxx, in September 2004 after linking it with heart attacks. Since then, such cox-2 drugs, which had become daily treatments for millions of people, have been in danger of removal from the market, calling into question the financial health of their makers and the rigor of the F.D.A.

The F.D.A. said today that it "will carefully review any proposal from Merck for resumption of marketing of Vioxx."

As for Bextra, it said that the drugs risks outweighed its benefits.

Pfizer responded in a statement that it "respectfully disagrees with F.D.A.'s position" and "will explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients."

The European Medicines Agency, which called for the drug's suspension in the European Union, said it would consider inviting Bextra back to market based on the results of its review of cox-2 inhibitors, which it began after Merck's withdrawal of Vioxx. The agency will release an update of its plans after an April 18-21 meeting of its Committee for Medicinal Products for Human Use.

For Pfizer, the world's largest drug maker, complying with the F.D.A.'s request may compromise the profit growth that the company forecast only on Tuesday in a meeting with Wall Street analysts. Though it said that 2005 would be a "transition year" of cost cutting and research spending, it had predicted double-digit earnings growth starting in 2006.

"It's a setback; we had been assuming that Bextra would probably be staying on the market," said Carl Seiden, an equity analyst at UBS who still rates the stock a buy. "We're going to assume that Bextra revenues are simply lost and not made up by Celebrex," the company's other oral cox-2 drug. That would mean a $560 million loss in worldwide revenues, or about 2 1/2 percent of the company's projected earnings, according to Mr. Seiden's calculations.

Still, he said, "relative to the strategic direction they set a couple of days ago," including a restructuring that would reduce costs by $4 billion a year, "this doesn't meaningfully change the company's trajectory."

Pfizer said it was not told of the F.D.A.'s decision to ask for Bextra's withdrawal from the market until Wednesday, a day after its meeting with analysts.

After falling for much of the day, shares of Pfizer on on the New York Stock Exchange closed up 4 cents, ending at $26.90.

Consumer advocates said they were pleased with Bextra's withdrawal but suggested that the F.D.A. could have moved sooner. A profile of Bextra on the F.D.A.'s Web site shows, for instance, that regulators were aware of the potential for skin reactions in October 2002 and accepted a revised label in November 2004 that described the risk more prominently.

"Given that there's not a whole lot of new information here, why is this happening in 2005 when the data that demonstrated risk were available years earlier?" asked Jeannine Kenney, senior policy analyst for the Consumers Union in Washington. "The F.D.A. should not be in this reactive position. They need to be implementing policies, and Congress needs to be passing new laws."

Senator Edward M. Kennedy, Democrat of Massachusetts, in a statement urged lawmakers to give the F.D.A. more power: "The FDA needs greater legal authority to require - not merely request - drug companies to do the right thing."

Among criticisms that have been directed at the F.D.A. are that it is too close to the industries that it regulates. The advisory panel that voted earlier this year to keep Bextra on the market included several former consultants to Pfizer. They said that relationship had not influenced their votes to allow continued marketing of the drug.

Drug companies do not necessarily need to comply with the F.D.A.'s request today for better labeling. In response to the suggestions, which affect Celebrex, the company said: "Pfizer and the F.D.A. plan further discussions regarding the precise content of the Celebrex label." It defended Celebrex's safety, citing clinical data spanning 10 years and involving more than 40,000 patients.

Sales for Celebrex last year totaled $3.3 billion, and those for Bextra totaled $1.3 billion. Sales of both drugs are now about half what they were last fall.

Once hailed as super-painkillers, cox-2 inhibitors like Celebrex, Vioxx and Bextra were seen as better treatments for persistent pain because they were less likely to cause stomach bleeding than common drugs like naproxen and ibuprofen.

Doctors may now advise their patients to return to those longstanding medications.

"The old-line drugs first, and then Celebrex," said Antonio Gotto, a cardiologist and dean of Weill Medical College at Cornell University.

"Where you have a patient that is known to have cardiovascular disease, or be at high risk of cardiovascular disease, I would not be inclined to treat him with Celebrex."


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