Other Drugs besides Vioxx might pose heart risks

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Other drugs besides Vioxx might pose heart risks

Marilynn Marchione,  Associated Press October 7, 2004 FDA1007

The safety of Celebrex and other pain relievers was questioned Wednesday as scientists in the United States and regulatory agencies in Europe said they feared such drugs might raise the same risk of heart problems as those blamed on the arthritis medicine Vioxx.One key researcher charged that the U.S. Food and Drug Administration (FDA) did not do everything needed to make sure the drug was safe and called for a congressional review of how Vioxx was approved.Vioxx was pulled from the market last week after its maker said a study showed it doubled the risk of heart attack and stroke. But the FDA said similar prescription drugs were safe.On Wednesday, the European Medicines Agency in London announced that it would review all drugs of this type. And researchers writing in the New England Journal of Medicine voiced their concerns as well with such drugs as Pfizer's popular Celebrex.The medical journal published two reports on the issue Wednesday on the Internet -- more than two weeks ahead of their planned print publication -- to help inform doctors and patients considering whether to stop using the drugs.Studies done five years ago when Celebrex and Merck & Co.'s Vioxx were approved suggest that the same mechanism that inhibits inflammation and makes the drugs easier on the stomach than traditional painkillers also blocks a substance that prevents heart problems, according to Dr. Garret FitzGerald, a University of Pennsylvania cardiologist. FitzGerald led the studies, which were designed by him but funded by the drug companies."I believe this is a class effect," he said, meaning that the problem also applies to Celebrex and Pfizer's newer, similar drug, Bextra, which remain on the market.He called on the FDA to change its advice to patients and doctors to reflect the new safety concerns.Pfizer's medical director, Dr. Gail Cawkwell, insisted its drugs are safe. "The data for Celebrex is robust and exceeds, in the length of patients in studies and in the size of studies, the data Vioxx has," she said.She said, "there is no evidence" of increased risk of heart problems among the 75 million Americans who have taken Celebrex.

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