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FDA Panel Gives Vioxx a Yellow Light

February 18, 2005
A federal advisory panel has given Merck a yellow light to bring painkiller Vioxx back onto the market, provided it carries a black box warning that it raises the risk of heart attack and stroke.

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The Food and Drug Administration advisory panel's finding also applies to other COX-2 painkillers, including Bextra and Celebrex. The FDA is not bound by the advisory panel's finding, but usually follows expert panels' recommendations.

The FDA said it would announce its decision within the next few weeks.

The panel strongly recommended that Vioxx and the other COX-2 drugs should not be promoted directly to consumers, warning that upbeat TV and print ads build demand for the medication among patients who might do well on less potent drugs.

Merck withdrew the anti-inflammatory drug from the market last year after Vioxx showed a twofold increase in serious cardiovascular events. Lawsuits rained down on the company and its stock price plummeted.

FDA scientist David Graham, who believes the drug caused more than 80,000 heart attacks and strokes in the United States since its 1999 launch, said he was disappointed with the panel's decision.

The FDA panel's recommendation was welcomed by millions of chronic pain sufferers who say the powerful COX-2 drugs are the only ones that give them any lasting pain relief. But medical experts say doctors will now be reluctant to prescribe the drugs in all but the most compelling cases.

Although multiple studies have found that the COX-2 drugs raise the risk of heart attack and stroke, other pain relief medications also carry risks. Aspirin and its derivatives can cause bleeding and narcotic-based drugs reduce alertness and can be habituating.

Several of the panel members recommended said that patients first try naproxen, sold as Aleve by Bayer, before taking any of the COX-2 drugs.

The vote recommending Vioxx be made available to consumers was close, 17-15. The advisory panel voted 31-1 to keep Celebrex on the market and 17-13 for Bextra.

"The data are very compelling; Vioxx is substantially worse than the others," said Alistair Wood of Vanderbilt University School of Medicine, the chairman of the FDA panel.

Wood also said physicians should be "more thoughtful" when prescribing Vioxx and the other COX-2 inhibitors.

Massachusetts Lawasuit

In Massacusetts, healthcare activists in Massachusetts sued Merck and Pfizer, charging their marketing campaigns misled consumers by advertising benefits of the drugs while not disclosing the full range of risks and shortcomings.

The suits were filed in Massachusetts state court Thursday, the day before President Bush signed a new law requiring such cases to be filed in federal courts.

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