Vioxx May Have Caused 140,000 Heart Attacks, FDA Scientist Says

Merck & Co.'s Vioxx painkiller may have caused as many as 140,000 heart attacks in the U.S. before it was withdrawn Sept. 30, Food and Drug Administration safety reviewer David Graham said in a study published online today by the British medical journal Lancet. The study was based on records of 1.4 million members of Kaiser Permanente, the largest U.S. nonprofit insurer, with 6 million members in California. Researchers compared the incidence of heart attacks and sudden cardiac death for patients taking Vioxx with those on Pfizer Inc.'s similar Celebrex and over-the- counter pain medications. Applying the findings across the U.S. population, ``we arrived at the estimate of 88,000 to 140,000 patients that had a heart attack in the U.S. because they used Vioxx,'' Graham, 50, said in a telephone interview yesterday. The drug was introduced in 1999. Portions of the study were disclosed earlier, starting with a medical conference in August. The U.S. regulatory agency published some of the findings in November, and Graham said in Nov. 18 testimony before the Senate Finance Committee that between 88,000 and 139,000 heart attacks may have been linked to Vioxx. Merck, the world's third-biggest drugmaker, withdrew Vioxx after a company study showed that patients taking it for 18 months or longer had twice the risk of heart attacks and strokes -- 1.5 percent -- as those taking a placebo.

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