Zelnorm ® – A Dangerous Drug?

As a Georgia injury lawyer, I am always reading about dangerous drugs. One such drug is Zelnorm ® , a drug used in the treatment of Irritable Bowel Syndrom (“IBS”) and chronic constipation in individuals under 65 years of age.
On March 30, 2007, the FDA requested that Novartis Pharmaceuticals Corporation (“Novartis”), the manufacturer of Zelnorm, voluntarily remove the drug from the market. The recall is based on findings of an increased risk of heart attacks and strokes associated with the drug from clinical trials recently reported by Novartis.
Novartis reported to the FDA the results of a new analysis of 29 short term randomized, controlled clinical trials of Zelnorm. The analysis included more than 11, 000 patients treated with Zelnorm and over 700 patients treated with Placebo. The data showed the serious risk of cardiovascular adverse events associated with Zelnorm to be higher than the Placebo treatment. Thirteen patients treated with Zelnorm had confirmed cardiovascular ischemic events and only 1 Placebo treated patient experienced a cardiovascular event.
The FDA has advised patients using Zelnorm to seek immediate medical care if they experienced severe chest pain, shortness of breath, dizziness or other symptoms of heart attack or stroke. Zelnorm has also been linked to serious cases of diarrhea, ischemic colitis and death. This prompted Novartis to amend its label in March 2004 to warn against these serious risks.