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Pfizer Says Celebrex Increases Heart Risk

Posted on: 12/17/2004

Pfizer Says Celebrex Increases Heart Risk

NEW YORK (Dec. 17) -- Pfizer Inc. says it has found an increased risk of heart attacks with patients taking its top-selling painkiller Celebrex, a drug that is in the same class as Vioxx, which was pulled from the market in September because of safety concerns.

Pfizer announced Friday that it found the increased risk in one of two long-term cancer prevention trials, while the other trial showed no increased risk.

The National Cancer Institute, which was conducting the study for Pfizer, suspended the use of Celebrex after finding that patients taking 400mg to 800mg of the drug daily were found to have a risk of 2.5 times greater of experiencing major heart problems than those who weren't. A separate cancer study found no increased heart risk with patients taking 400mg of Celebrex per day.

Pfizer was conducting the trials as part of an effort to find a new application for the drug.

The news sent the stock of the giant pharmaceutical maker plunging in morning trading on the New York Stock Exchange, where its shares were down $4.14, or more than 14 percent, at $24.84 in heavy volume.

Both Celebrex and Vioxx, which is made by Merck & Co., are a type of drug called cox-2 inhibitors, which have become popular because of their effectiveness in treating the pain of arthritis and other ailments.

Celebrex is the most-prescribed drug for treating arthritis. In the nine months ending in September, worldwide sales of Celebrex more than doubled from the same period a year earlier to $2.29 billion, accounting for 6 percent of Pfizer's total income of $37.59 billion.

Pfizer did not indicate that it was withdrawing Celebrex from the marketplace.

The withdrawal of Vioxx has been a financial and public relations disaster for Merck. Its legal liabilities are estimated at up to $18 billion, and its shares have dropped by nearly one-third since the recall announcement was made in late September.

Vioxx had been a blockbuster drug for Merck, it's No. 2 earner with annual global sales of $2.5 billion, amounting to 11 percent of the company's $22.49 billion in revenue last year. Some 2 million people worldwide had been taking Vioxx.

Dr. Joseph Feczko, president of worldwide development for Pfizer, noted that the results in the trial finding increased risk of heart attacks were not consistent with either the other cancer prevention trial or with a "large body of data" that the company had collected.

"Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world," Pfizer's chief executive Hank McKinnell said in a statement

Earlier this month, the Food and Drug Administration said it was adding a warning to the labels of another Pfizer drug, Bextra, noting a risk of potential heart problems associated with the use of Bextra in people who have recently had heart bypass surgery. Bextra is also a cox-2 inhibitor type of drug.

12-17-04 10:13 EST

Copyright 2004 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.

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