Zelnorm recalled after high rate of heart attacks and strokes

One patient on Zelnorm died from heart problems

On March 30, 2007, at the request of the United States Food and Drug Administration (FDA), pharmaceutical manufacturer Novartis AG announced a recall of the anti-constipation drug Zelnorm (generic name tegaserod). The FDA’s request came after studies indicated a high risk of heart attack or stroke for patients on the drug. John Jenkins, director of the FDA’s Office of New Drugs, said in a statement that the FDA believed “the risk versus benefit profile for Zelnorm was no longer favorable.”

An analysis of 11,600 patients involved in 29 clinical studies of Zelnorm showed a higher rate of heart attacks, strokes, and related heart problems while on the drug. Thirteen patients in the studies had serious cardiovascular side effects while on Zelnorm, including:

• Four patients who suffered heart attacks,
• Three patients who suffered strokes,
• Six patients who had angina, or severe chest pain which can quickly progress to cardiac arrest, or heart attack, and
• One patient who died while on the medication.

When Zelnorm was approved for sale in the United States in 2002, Novartis AG reported a “small (but not statistically significant) imbalance in cases of angina pectoris,” or acute chest pain, in patients treated with Zelnorm that was added to the drug’s safety label. All the patients in these studies had pre-existing cardiovascular disease. Patients taking placebos had an unexpectedly low rate of heart attacks.

In a press release announcing its compliance with the FDA’s request, Novartis AG included a statement from Dr. Jeffrey L. Anderson, professor of internal medicine at the University of Utah and associate chief of Cardiology at LDS Hospital in Salt Lake City. “My review of the data suggests a causal relationship is unlikely between tegaserod and the rare cardiovascular ischemic events observed in clinical trials,” Anderson said.

According to Novartis AG the rate of cardiac events associated with Zelnorm “corresponds approximately with the expected rates for such events in the general population.”

Zelnorm has failed to win approval for marketing in the European Union and was rejected for a second time in March 2006. The European Medicines Agency committee reviewing Zelnorm said “Zelnorm’s benefits are not greater than its risks.”

Sources: Eva von Schaper, “Novartis Stops Zelnorm Marketing, Sales on Heart Risk,” Bloomberg.com, March 30, 2007; Jennifer Corbett-Dooren and Goran Mijuk, “Novartis to Suspend U.S. Sales of Zelnorm on FDA Request,” Wall Street Journal, March 30, 2007; “Novartis Suspends US Marketing and Sales of Zelnorm in Response to Request from FDA,” Novartis Pharmaceuticals Corporation, March 30, 2007.