Pfizer says Celebrex safe following newspaper report

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Pfizer Inc. said on Thursday its arthritis drug Celebrex was safe after a report in a Canadian newspaper linked it to 14 deaths.

The National Post said the deaths were among 100 reports of adverse reactions to Celebrex filed with Health Canada over the past five years, including 19 cases of heart problems and five strokes. The results did not stem from a controlled clinical trial.

Pfizer said the news report was “misleading” and “not supported by any clinical or epidemiological studies and has the potential to cause undue confusion among patients and physicians.”

The company said the safety profile for Celebrex is well-established and supported by extensive clinical studies in Canada and around the world.

Pfizer shares were down 2.3 percent in afternoon trading after dropping as much as 6.2 percent following the newspaper report.

“Any news along these lines is not reassuring, but in light of the fact that these are random case reports I would not put too much weight on them,” said Steve Scala, an analyst at SG Cowen. “There’s a lot we don’t know, and from controlled clinical studies there have not been similar results.”

The Canadian government said it had no proof the drug caused deaths.

“There hasn’t been a causal link established,” Health Canada spokeswoman Jirina Vlk said. “It may be connected to the 14 deaths or it may not have been connected to the 14 deaths....It is important to remember that the adverse reports represent only the suspicion, opinion or observation of the individual person providing it.”

Pfizer argues that Celebrex does not have the same safety problems as Merck & Co. Inc.’s Vioxx, which was pulled from the market after a study showed the drug increased the risk of heart attack and stroke.

Celebrex, which had sales of 2003 of $1.9 billion, is in the same class of drugs as Vioxx. Both are known as COX-2 inhibitors. The withdrawal of Vioxx has cast a cloud of suspicion over all members of the class, including Celebrex and another Pfizer drug, Bextra.

COX-2 inhibitors block an enzyme in the body called cyclooxygenase that contributes to inflammation and pain.

Pfizer has said it plans a major new trial to test whether Celebrex helps protect the heart. The study is scheduled to begin in early 2005 and will compare Celebrex to a placebo. 

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