Constipation Drug Causes Heart Attacks, FDA Halts Sales
The pharmaceutical company Novartis has agreed to halt sales of Zelnorm® at the FDA’s request, after it was linked to a higher chance of heart attack, stroke and worsening chest pain that can become a heart attack.
Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation, the agency said. Zelnorm is marketed in 55 countries.
The FDA is advising patients using Zelnorm to discuss treatment alternatives with their doctors. The agency advised patients taking Zelnorm to seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.
Throughout February and March 2007, Novartis reported to the FDA the results of a new analysis of 29 short-term clinical trials of Zelnorm. Based on the data for most patients, the benefits of this drug no longer outweigh the risks, the agency said.
The analysis included more than 11,600 patients treated with Zelnorm and over 7,000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm are higher than with placebo treatment.
Public Citizen, a consumer advocacy group, said that there were 2.13 million prescriptions issued for Zelnorm in 2005 alone, making it one of the top 200 drugs in the country. The organization also said that it had warned the FDA in 2001 not to approve the drug for safety reasons.
“Once again, the FDA has approved a drug with marginal effectiveness in the face of serious questions about its safety – putting at risk the millions of people who have already used it,” said Dr. Sidney Wolfe, director of Public Citizen’s health research group.
There are other medicines available by prescription, and alternative therapies such as Chiropractic adjustments and Acupuncture; both have proven effective for some patients.