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Bextra Risk Claims Add To Controversy

Nov 10, 2004 |

A scientist's claim of evidence that Pfizer Inc.'s Bextra might be as dangerous for high-risk cardiac patients as recalled rival arthritis drug Vioxx created a controversy Wednesday and helped dent Pfizer's stock.

According to the preliminary results of study,
presented Tuesday at the American Heart Association meeting in New Orleans, an investigational form of Bextra roughly doubled the risk of heart attacks and strokes in high-risk cardiac patients who underwent coronary artery bypass grafting.

In a statement released Wednesday, Pfizer (PFE)
emphasized that the coronary bypass study results have not yet been subjected to an independent scientific review.

The company also noted that clinical trials involving nearly 8,000 patients suffering from osteoarthritis or rheumatoid arthritis revealed no increased cardiovascular risk. Bextra has been approved by the FDA to treat those conditions and menstrual cramps.

Pfizer said in a Nov. 5 regulatory filing that the Food and Drug Administration had rejected an
application to use Bextra to treat migraines.

Dr. Garret FitzGerald, a University of Pennsylvania cardiologist, told the medical conference that he had reanalyzed previously published studies on Bextra and concluded that it increased the risk of heart attacks and strokes.

Bextra and Pfizer's blockbuster pain reliever Celebrex have come under harsh scrutiny since rival Merck (MRK)was forced to withdraw its painkiller Vioxx from the market in October after long-term usage was linked to a higher incidence of heart attack and stroke. All three drugs are chemically similar, belonging to a class of drugs called COX-2 inhibitors.

Pfizer spokeswoman Susan Bro said Pfizer previously announced its intention to conduct larger, long-term clinical studies of Bextra. She said the company was working closely with the Food and Drug Administration.

Pfizer also said that the agency plans to convene an advisory panel in February 2005 to review the cardiovascular safety profiles of all COX-2 inhibitors.

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