Subaqua Sternal Rubs

I know I've been slacking on this Vioxx thing, but in case you haven't heard:

Last week, an FDA advisory panel decided that painkillers Vioxx, Celebrex and Bextra carry cardiovascular risks but recommended that the FDA support their being marketed. Merck suggested it would consider putting Vioxx back on the market if the FDA approved and if competing drugs stayed on the market.

If Merck puts painkiller Vioxx back on the market after removing it because of safety concerns, it would be an unusual but not unprecedented event.

Among drugs approved by the Food and Drug Administration since 1990, 14 have been withdrawn from the U.S. market for safety reasons, says consumer watchdog group Public Citizen. Only Lotronex, approved to treat irritable bowel syndrome in women, has so far been reintroduced.

That happened in 2002, two years after Lotronex went off the market and only after the FDA restricted its use. Merck might likewise face restrictions on Vioxx, and that might make a re-launch unattractive, says Winton Gibbons, health care industry analyst with investment bank William Blair.

"It may not be economically advantageous," he says.

What happened to Lotronex might dampen enthusiasm. The drug was pulled from the market in 2000, less than a year after it got FDA approval, by maker Glaxo Wellcome because of reports of severe gastrointestinal side affects. Glaxo and the FDA also couldn't agree on how to manage the risk.

The drug's removal caused an outcry from consumers. They lobbied the FDA, saying they would accept the drug's risk to get the benefit. An FDA advisory panel recommended it be returned to market with restrictions, which the FDA did in 2002. It restricted the drug to women with severe symptoms and for whom other treatments failed. Among other things, patients have to sign consent forms indicating they're aware of potential risks. Doctors must enroll in a program to assure they understand them.

GlaxoSmithKline, formed from a merger, doesn't break out Lotronex revenue because it's not one of the company's biggest-selling drugs. But its universe of users has shrunk.

From March 2000 to the following December, 534,000 Lotronex prescriptions were written for 275,000 patients, Glaxo says. From November 2002, after its return, to February 2004, only 35,000 prescriptions had been written for 10,000 patients.

Source: USA Today

Will the fate of Vioxx be similar? Most likely as doctors will likely shy away from prescribing a medication that is the subject of a mass advertising campaign by the nation's bloodsucking malpractice legal professionals.

Inspiration: GruntDoc

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