FDA Asks Novartis to Suspend Marketing of GI Drug Zelnorm

The U.S. Food and Drug Administration (FDA) notified Novartis Pharmaceuticals Corporation that the company must cease its marketing of Zelnorm (tegaserod), a prescription drug used in the treatment of constipation and irritable bowel syndrome (IBS). According to the FDA, Zelmorm has been associated with an “increased risk of serious cardiovascular adverse events (heart problems).” Novartis has agreed to voluntarily suspend its marketing of Zelnorm.

Zelnorm was first approved by the FDA in 2002 to treat constipated women with IBS, and the approval was expanded two years later to treat chronic constipation in both men and women younger than 65. However, recent randomized trials conducted by Novartis have called into question the drug’s safety, and the FDA now says that “for most patients the benefits of this drug no longer outweigh the risks.” According to the data, “the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment.”

“This decision reflects the FDA’s commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits,” said Dr. Douglas Throckmorton, deputy director for the Center for Drug Evaluation and Research. “Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary.”

The FDA recommends that Zelnorm patients who experience severe chest pain, shortness of breath, dizziness, difficulty walking or talking, or other symptoms of a heart attack or stroke should contact their doctors immediately.

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