GlaxoSmithKline Drug for Irritable Bowel Syndrome Makes Unprecedented Comeback.

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marketing program for the drug, the first time the agency has ever permitted a company to sell a drug after it was withdrawn from the market because of safety concerns.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 of serious health problems in people who took the drug.

Irritable bowel syndrome, or IBS, affects an estimated 18.5 million Americans. It causes lower abdominal pain and irregular bowel habits, including constipation and diarrhea so severe that it can disrupt every aspect of a person's life.

"I'm just thrilled that people will be able to get on with their lives," said Maria A. Zargo, an IBS patient in Brookfield, Conn. After Lotronex was pulled from the market, she had to quit her job as a human resources administrator because she couldn't make the 45-minute commute to work.

The restricted marketing program approved by the FDA seeks to limit health risks by restricting Lotronex as much as possible to a small subset of IBS patients -- women who have severe symptoms that haven't responded to other treatments and who suffer predominantly from diarrhea. Fewer than 5 percent of IBS cases are considered severe, and only a fraction of those cases are diarrhea-predominant, according to the FDA.