Novartis restricts Zelnorm to emergencies

Goodbye cruel world. Novartis is pulling the irritable bowel med Zelnorm off the market almost completely, saying it will supply the drug only for emergency use. And even in emergencies, Zelnorm will only be available to patients who don't smoke, and don't have high blood pressure or diabetes or eight other preexisting conditions. And docs who want it must ask the FDA for authorization.

Talk about going out with a whimper. Zelnorm racked up $560 million in sales in 2006, then was withdrawn in March 2007 after it was shown to boost the risk of heart attck, strokes, and chest pain. Novartis eventually made a deal with the FDA to supply Zelnorm to a limited number of patients because it was the only remedy approved for irritable bowel treatment. Eight months later, bye-bye. FDA says the withdrawal was voluntary; we'll have to wait and see whether Novartis offers an explanation.

- see the FDA's press release
- read the Pharmalot item

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