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Study: Vioxx Dose Can Harm Heart

Aug 26, 2004 | Bloomberg News

The painkiller Vioxx increases the chance of heart attack and death from cardiac arrest more than Celebrex does, according to a large study financed by the Food and Drug Administration.

The FDA's David Graham said patients taking the typical starting dose of Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death than patients taking any dose of Celebrex. He presented the findings at a meeting of the International Society for Pharmacoepidemiology in Bordeaux, France.

Researchers came up with the findings after analyzing the medical records of 1.4 million people insured by Kaiser Permanente, the Oakland, Calif.- based health maintenance organization.

The study also found that Vioxx doses of more than 25 mg a day more than tripled the risk compared with patients who hadn't taken painkillers within the past two months.

Vioxx and Celebrex are designed to be gentler on the stomach than older drugs.

Graham said his new findings don't reflect FDA's official position and are the views of the authors.

Mary Elizabeth Blake, a spokeswoman for Vioxx manufacturer Merck & Co., disputed the findings. Conclusions from that type of examination don't carry as much weight as results from a study comparing two groups of patients actually taking the medicines for a set period of time, she said.

Most patients take daily Vioxx doses of 12.5 mg or 25 mg for arthritis. But a higher dose of 50 mg is approved by the FDA for treatment of pain for no longer than five days.

"The problem is that some patients continue to take it for 30, 60, or 90 days," putting themselves at elevated risk of heart attack and sudden cardiac death, Graham said.


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