Zelnorm^® is a drug used in the treatment of irritable bowel syndrome (“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 risk of serious cardiovascular adverse events associated with Zelnorm^® to be higher than with placebo treatment.  13 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 experience 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.

If you or a loved one has experienced any of the above injuries or symptoms, or have legal concerns related to this drug, please contact us for a Free Claim Evaluation, by calling us at (866) 495-5189 or via this Contact Us link.  You may be legally entitled to recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment.  For persons who have died, their surviving spouse or other family members often can bring a wrongful death action.

Milberg LLP
One Pennsylvania Plaza, 49th Fl.
New York, NY, 10119-0165
Phone number: (866) 495-5189
Email: contactus@milberg.com
Website: http://www.milberg.com

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