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Recalled drug could see unprecedented return to market

Increased vigilance would be called for in supervising patients taking Lotronex for irritable bowel syndrome.

By Susan J. Landers, amednews staff. June 3, 2002.

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Washington -- The Food and Drug Administration and the manufacturer of a medication that was touted by many as the only effective treatment for irritable bowel syndrome are discussing whether the drug should be returned to the market after being recalled.

If alosetron hydrochloride, Lotronex, does become available after a safety recall it would be a first, said an FDA spokesman.

In February 2000, the agency initially approved Lotronex for use by women with IBS. (Clinical trials had included too few men to allow approval of the drug for men, but many were prescribed it off-label.)

However, the drug was voluntarily withdrawn by its manufacturer, Glaxo Wellcome, in November 2000, after numerous reports of serious adverse effects, including ischemic colitis and complications from constipation. Lotronex was thought to be the contributing cause in seven deaths, according to the FDA.

The drug's withdrawal prompted a major outcry by those for whom Lotronex had proven very effective, prompting the agency to take another look at the medication.

As of mid-May the FDA was still negotiating with the manufacturer, now known as GlaxoSmithKline, on conditions agreeable to both that would allow for the drug's return to the market.

Following a joint public hearing, the FDA's Drug Safety and Risk Management Subcommittee and Gastrointestinal Drugs Advisory Committee recommended the drug be returned to the market with certain restrictions.

The committees advised prescribing the drug only to patients with the most severe symptoms and requiring that they receive counseling about the drug's potential risks. [...]