Irritable Bowel Syndrome

FDA advisers call for return of bowel drug

Published in Medical Letter on the CDC and FDA, May 26th, 2002

A once-popular drug for irritable bowel syndrome appears headed back to the U.S. market with tough new restrictions aimed at mitigating risks that forced the manufacturer to stop selling it 17 months ago.

Heeding pleas from patients desperate to regain what they called a miracle therapy, advisers to the U.S. Food and Drug Administration on April 23, 2002, said the drug Lotronex should be sold again.

But they recommended that it be prescribed only by doctors who have undergone special training to use it, and given only to the sickest patients, who must register in a national database that will track how they fare.

Manufacturer...

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Source: Medical Letter on the CDC and FDA (2002-05-26)

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