The U.S. Food and Drug Administration announced new labeling for a broad swath of arthritis pain drugs, including Advil, Aleve and Motrin. Pfizer's blockbuster Celebrex will get the most serious type of warning the FDA can level and Bextra, another Pfizer arthritis drug, will be removed from the market in the U.S. and in Europe.

Analysts and doctors agreed that since Bextra is being pulled Merck's (nyse: MRK – news – people) similar Vioxx, which was withdrawn in September, is unlikely to ever return to the market. At first glance, the FDA's decision seems to contradict the advice of a 32-person advisory panel that the agency convened in February.

"My first reaction is surprise, since the FDA panel advised that Bextra be kept on the market," says Antonio Gotto, Dean of the Weill Cornell Medical College. "I think the FDA is being extremely cautious-they're taking the position that there are alternative drugs."

The FDA has apparently decided to side with the drug safety experts and cardiologists, who comprised only half the panel, and not with doctors who treat arthritis and would more frequently prescribe Bextra. Additionally, some panelists say, the up or down vote on Bextra obscured more broad concerns about the drug's safety.

"I think the FDA made a decision about the overall safety of this drug and felt that there were alternatives," says Steve Abramson, Chairman of Rheumatology at New York University's Hospital for Joint Diseases. He was on the panel and voted that Bextra should be kept on the market. But he says he feels the FDA's decision takes into account the totality of discussion on Bextra. Many panelists worried that Bextra, like many other arthritis drugs, might pose a risk. Worse, he says, studies on the drug were not extensive enough to provide clear answers.

Byron Cryer, an expert in gastrointestinal side effects who was a nonvoting adviser to the FDA panel, says that he does not view the decision as being counter to the panel's advice. The vote for Bextra (17 for, 13 against, two abstaining) was very close to the 17-15 vote for Vioxx. Eric Topol, Chairman of Cardiology at the Cleveland Clinic and one of the most vocal critics of Bextra and Vioxx, says that he saw the FDA panel split mostly between arthritis doctors and others.

Steven Nissen at the Cleveland Clinic, an FDA panelist who voted to keep Bextra on the market, said that he thought the FDA had acted very reasonably. The panel had not been asked to consider a second safety issue, called Stevens-Johnson Syndrome, a rare and potentially deadly skin reaction for which Bextra already has a boxed warning. That may further decrease the risk-to-benefit of the drug. "I support their decision," says Nissen, "I think that's very reasonable."

In a prepared statement this morning, Pfizer (nyse: PFE – news – people) said that the FDA had told it that Bextra's risk to the heart was not distinguishable from other drugs and that it was the skin reaction that led to the decision. (Pfizer disagrees with the FDA's decision and is in continued discussion with the agency.) Garret FitzGerald at the University of Pennsylvania, who was one of the first to argue that drugs such as Celebrex or Vioxx might pose a risk to the heart but also believes they have a place, said the heart risks must have played a role. "I think you have to consider that these are folded together in terms of looking at a drug's overall profile," says FitzGerald.

For Pfizer, the decision may have only a limited effect on its financial guidance. Barbara Ryan, an analyst at Deutsche Bank, said that she thinks Pfizer can probably find more cost cuts on top of the $4 billion in planned cost savings it announced on Tuesday.

For many patients, the news is likely to be incredibly confusing, and even dispiriting, as they try to grapple with drugs that they thought were the only treatment for their pain. Says Cornell's Gotto: "There are patients who are literally hoarding these drugs."

 



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