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The U.S. Food and Drug Administration (FDA) has advised individuals who are being treated with Zelnorm to contact their physician to discuss alternative treatments. According to the FDA, patients who use Zelnorm and experience any of the following symptoms should immediately seek emergency care:
If you or a loved one has suffered an adverse Zelnorm side effect, ensure your legal rights are protected by contacting an experienced attorney near you today.
Zelnorm Side Effects Reported in Clinical Trials
In the many clinical trials conducted to examine the benefits and risks of Zelnorm treatment for irritable bowel syndrome (IBS), the following side effects occurred more often among the patients treated with Zelnorm than among those who received a placebo:
Other Zelnorm side effects include:
Further Recommendations by the FDA
The FDA pulled Zelnorm from the market in March 2007 after Novartis Pharmaceuticals, the drug's maker, submitted analyses linking Zelnorm to severe side effects such as heart attack and stroke. According to the FDA, Zelnorm treatment should be discontinued in people who develop hypotension or syncope, and Zelnorm treatment should not be used for patients who frequently have or are presently experiencing diarrhea. The FDA also advised that Zelnorm treatment be stopped in patients who develop any symptoms of ischemic colitis, such as bloody diarrhea, rectal bleeding, and the onset or worsening of abdominal pain.
The FDA concluded that for most patients, the benefits of Zelnorm do not outweigh its risks.
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