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VIOXX May Not Be Only One

Researchers Warn of Dangers of Other Vioxx-Type Drugs

"The senior executives at Merck and the leadership at the FDA share responsibility..."

Oct. 7, 2004 - The sudden withdrawal of Vioxx from the market may not have ended the danger of adverse side effects from COX-2 inhibitors. Researchers writing in the New England Journal of Medicine say similar popular drugs of the same class, like Pfizer's Celebrex, may pose similar risks.

The researchers also said that "tens of thousands" of patients may have suffered adverse effects from taking Vioxx. Cleveland Clinic researcher Eric J. Topol said the number of patients who have had heart attacks or strokes as a result of taking Vioxx could range from 30,000 to 100,000.

A Food and Drug Administration (FDA) official recently estimated that Vioxx may have harmed more than 27,000 patients, based on a study of Kaiser Permanente patients.

Vioxx and Celebrex have been among the most widely prescribed medications in the United States in recent years. The powerful painkillers made life more comfortable for patients with arthritis and other painful conditions.

In a separate article in the New England Journal of Medicine, Garret A. FitzGerald of the University of Pennsylvania said his research leads him to suspect that Celebrex and other COX-2 inhibitors could have cardiovascular effects similar to those linked to Vioxx. He said clinical trials of all COX-2 inhibitors showed elevated cardiovascular risk, similar to Vioxx.

All COX-2 inhibitors should be viewed as risky and the FDA should "urgently" adjust its policies to "reflect this new reality," FitzGerald wrote.

Merck withdrew Vioxx last week after a large study found a significantly increased risk of cardiovascular disease and strokes in patients given Vioxx.

Both researchers criticized FDA for not being more aggressive in ensuring the drugs were safe. Topol was especially critical of the agency for allowing Merck to advertise the drug so aggressively despite concerns about possible cardiovascular risks.

"The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health," Topol wrote.

Pfizer yesterday said clinical trails have shown that Celebrex does not pose the same risks as Vioxx and said patients have no reason to be concerned.

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