GlaxoSmithKline Drug for Irritable Bowel Syndrome Makes Unprecedented Comeback.

Publication: The News & Observer (Raleigh, North Carolina) (via Knight-Ridder/Tribune Business News)

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COPYRIGHT 2002 The News & Observer

Byline: David Ranii

Jun. 8--Lotronex, the GlaxoSmithKline drug for irritable bowel syndrome that has inspired ardent support from patients who say it changed their lives as well as withering attacks from critics who say it kills people, has made an unprecedented comeback.

Friday, the U.S. Food and Drug Administration approved a restricted marketing program for the drug, the first time the agency has ever permitted a company to sell a drug after it was withdrawn from the market because of safety concerns.

The decision is a victory for sufferers of irritable bowel syndrome who have been lobbying for Lotronex's return ever since GSK pulled it from the market in November 2000. The FDA requested the withdrawal in response to reports of five deaths and dozens of instances...

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