04 | 9 | 2007 Posted By George L. Garrow, Jr., of The Garrow Law Firm, DC

Studies Suggest that Zelnorm May Cause Heart Attack, Stroke and Other Serious Injuries

The FDA issued a public health advisory on March 30 to inform patients and others that Norvartis, sponsor of Zelnorm (tegaserod maleate), has agreed to stop selling the drug. As noted in Garrow & Evans’ earlier blog (see Zelnorm (Tegaserod), Causing Injury, Is Pulled From the Market, April 3, 2007), Zelnorm has been removed from the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a placebo (sugar pill) they thought was Zelnorm.

What advice does the FDA give consumers who once relied (or still rely) on this drug for constipation?

  1. Seek emergency medical care if experiencing severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking, talking or other symptoms of a heart attack or stroke.
  2. Consult with you doctor as soon as possible, even if you have no symptoms, to discuss other treatment options.
  3. Ask your doctor to monitor the health of your heart over the coming months --- just to be sure.