The FDA will allow some patients to receive Novartis' irritable bowel syndrome drug, Zelnorm (tegaserod), under a restricted access programme. Novartis said the company and the US agency are "moving forward with this programme because of requests from physicians and patients" after the drug was withdrawn over safety concerns.
Under the programme, the drug will be available to women under 55 years of age who have IBS with constipation or chronic idiopathic constipation, and whose doctors decide that the treatment is necessary. "These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug. Zelnorm will remain off the market for general use," explained Steven Galson, the director of the FDA's Center for Drug Evaluation and Research.
The US regulator requested that Zelnorm be withdrawn from the market in March, after a safety analysis revealed an increased risk of cardiovascular events in patients taking the drug. In 2006, the compound had global sales of $561 million.
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