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Celebrex, Bextra, Vioxx can stay
FDA panel says the painkillers should stay on the market despite risks; Vioxx draws a split vote.
February 18, 2005: 4:48 PM EST

WASHINGTON (CNN) - While the painkillers Celebrex, Bextra, and Vioxx significantly increase the risk of cardiovascular problems, the danger is not great enough to justify taking the drugs off the market, according to an advisory committee of the Food and Drug Administration.

The advisory committee voted on whether to stop sales of the drugs Friday during a third and final day of considering the risks associated with taking Cox II selective non-steroidal anti-inflammatory drugs (NSAIDs).

The votes are non-binding.

The 32-member panel unanimously agreed that each drug "significantly increases the risk of cardiovascular events."

But in a 31-1 vote, the panel decided the overall risk posed by Celebrex is not enough to require removing the drug from the U.S. market.

The votes on Bextra and Vioxx were much closer.

When considering Bextra -- which many experts say has not been tested as thoroughly -- 17 members agreed the drug should stay on the market, 13 voted against the measure, and the remaining two abstained.

The panel voted 17-15 in favor of continuing sales of Vioxx, which was voluntarily taken off the market in September.

When explaining their votes to keep Vioxx on the market, the panel members suggested the FDA issue a stronger "black box" warning label detailing the risks of hypertension and cardiovascular side effects, as well as restrict higher doses of the drug. Other suggestions included monitoring blood pressure in all patients, eliminate the 50 milligram dosage, as well as require informed consent from adult patients

Pharmaceutical manufacturer Merck & Co. (Research), which manufactures Vioxx, said in a statement released in reaction to the vote: "Merck has appreciated the opportunity to present data at this advisory committee meeting. We look forward to discussions with the FDA."

The committee recommended the FDA take certain actions to warn consumers about Celebrex, including a ban on direct marketing to consumers, a patient guide the drug, and a black box warning -- the highest level of warning that can go on a label -- which will address the cardiovascular risks of taking the medication.

"Obviously, drug companies don't like to have these (black box warnings) on their products because it would make a physician think twice or more than that before prescribing it," CNN Medical Correspondent Elizabeth Cohen said.  Top of page


Merck & Co.
Food and Drug Administration (FDA)
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