IBS Drug Zelnorm Taken Off U.S. Market

FDA: Voluntary Withdrawal Due to Risk of Heart Attack, Stroke, Chest Pain

A popular drug for irritable bowel syndrome and constipation was pulled from the U.S. market Friday amid new evidence that it raises the risk of heart attacks and strokes. Novartis, the manufacturer of Zelnorm, confirmed that Food and Drug Administration officials asked for the drug’s withdrawal.

Agency officials said they based their decision on a Swiss government analysis of 29 Zelnorm studies that showed a higher chance of cardiovascular events, such as heart attack, stroke, or severe heart-related chest pain in patients treated with Zelnorm compared with those given a placebo. The analysis turned up 13 cases of heart attack, stroke, or angina (chest pain related to heart disease) in about 11,600 patients who took the drug. One of the 13 died, the agency said. This was compared with just one nonfatal event in more than 7,000 patients who took the placebo. John Jenkins, MD, head of the FDA’s Office of New Drugs, described the overall number of dangerous events as “quite small.” But he said the rate of cardiovascular events -- about 10 times higher in patients taking Zelnorm -- raised alerts about the drug.

Bonnie - this drug was very controversial because it was heavily marketed to women by showing pictures of tight, bare-midrift tummies, implying that you could look like that if you take Zelnorm.