Originally published March 1 2005
History tells us that the reintroduction of Vioxx into the market may not be as easy as many believe
by Mike Adams, the Health Ranger, NaturalNews Editor
While the FDA approved the reintroduction of Vioxx into the marketplace, it may not occur after all. The only other drug to make such a comeback was Lotronex, a medication used to treat irritable bowel syndrome, and it was reintroduced to a very small market. Vioxx may face similar problems, as the black box warning labels and other regulations may make it difficult to find patients willing to take the drug.
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Among drugs approved by the Food and Drug Administration since 1990, 14 have been withdrawn from the U.S. market for safety reasons, says consumer watchdog group Public Citizen.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.
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.
The drug was pulled from the market in 2000, less than a year after it got FDA approval, by maker Glaxo Welcome because of reports of severe gastrointestinal side affects.
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.
Last week's FDA panel indicated a preference for all three painkillers to carry labels detailing their heart risk and for a ban on consumer advertising.
A handful of members suggested patient consent forms be required, and several recommended limiting Vioxx to patients for whom other drugs don't work.
The Vioxx vote, though largely split, might help Merck's defense against hundreds of lawsuits alleging that it knew long before it pulled Vioxx of its risks --- an allegation it denies.
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