Posted by Kate Murphy on April 2nd, 2007
Novartis has agreed with the FDA to a voluntary withdrawal of Zelnorm® from the market. New information has shown an increased risk of serious cardiovascular events including heart attack, chest pain, and stroke in patients using Zelnorm.
After reviewing data from a pooled analysis of nearly 30 short-term randomized clinical trials comparing Zelnorm (tegaserod) to placebo, the FDA decided that its risks outweighed its benefits and asked Novartis to voluntarily withdraw the drug on March 30, 2007.
Over 18,000 patients were involved in the trials, 11,000 on Zelnorm and 7,000 on placebo. Although the risk for adverse cardiovascular events was small, it was significantly higher in those patients who were taking Zelnorm.
The FDA is telling patients and doctors:
Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
Patients who are taking Zelnorm should seek emergency medical care right away 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.
Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.
Zelnorm was approved by the FDA for women with constipation associated with irritable bowel syndrome (IBS). Irritable bowel syndrome causes lower abdominal pain, cramps, bloating, and constipation or diarrhea. Zelnorm was not appropriate for IBS-associated diarrhea, and there was no evidence that it was effective in men.
In 2004, the FDA warned about severe diarrhea, dehydration, and ischemic colitis associated with Zelnorm use and changed labeling to include warnings about its use in patients who already were experiencing diarrhea. Changes to the patient information told them to stop the use of Zelnorm and contact their doctors if they experienced worsening stomach pain, rectal bleeding, or bloody diarrhea — all symptoms of ischemic colitis.
The FDA will work with Novartis to allow access to Zelnorm as an investigational drug in cases where there is no other option for treating IBS with constipation and where the benefits may outweigh the risks.
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