Zelnorm Recall

Staff Writer
Contributor
Posted by Staff WriterMarch 31, 2007 5:55 PM

The popular drug used to treat irritable bowel syndrome, Zelnorm, was pulled from the market Friday by Novartis, the drug's manufacturer. Zelnorm has been linked to an increased risk of heart attack and stroke, and the FDA recommended Novartis recall the drug.

It was the second drug recall in two days. Pergolide, a Parkinson's medicine originally sold by Eli Lilly as Permax and now in generic form, was withdrawn Thursday be cause of links to heart valve problems.

Zelnorm was approved in 2002 for short-term treatment of women who suffer from irritable bowel syndrome with constipation, and in 2004 for men and women younger than 65 with chronic constipation. In 2004, a new warning label was added about side effects including diarrhea and colitis.

The FDA said doctors who prescribe Zelnorm should work with their patients and transition them to other therapies. An estimated 12 million Americans suffer from the painful and disruptive symptoms of irritable bowel syndrome with constipation.

Zelnorm had about $500 million in sales in 2006.

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