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FDA panel narrowly allows Vioxx sales to resume Regulator imposes strict warnings and patients must sign consent forms

Regulator imposes strict warnings and patients must sign consent forms

A special advisory panel to the U.S. Food and Drug Administration voted yesterday to allow the possible return of the painkiller Vioxx under strict conditions that would see patients sign consent forms acknowledging the medication increases the risk of heart attack and stroke.

Merck & Co. withdrew the anti-inflammatory drug from the market last year after Vioxx showed a twofold increase in serious cardiovascular events. The move prompted regulators to investigate further the heart risks of all other medications in the Vioxx pain-reliever class known as cox-2 inhibitors.

The panel said yesterday that all cox-2 drugs should carry black-boxed warnings about their heart risks -- the strongest precaution available. This would apply to Pfizer drugs Celebrex and Bextra, and Vioxx, if Merck brings it back. The FDA is not bound to follow the recommendations.

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 Vioxx decision.

Federal Health Minister Ujjal Dosanjh said Canada will make its own decision about Vioxx. Health Canada spokeswoman Catherine Saunders said Merck would have to resubmit an application to resume sales.

A Globe investigation into events that preceded the withdrawal of Vioxx has found safety issues related to the drug were lost in a volatile mix of marketing and medicine. Documents show drug regulators had serious concerns about its heart risks for five years, yet could not force the company to investigate them fully.

Merck, meanwhile, turned Vioxx into a blockbuster drug, battling concerns from academic scientists and clinging to the prospect that a heart-attack risk first uncovered by a Canadian scientist-led study could be otherwise explained.

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