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drug_recall zelnormZelnorm—the Novartis drug used to manage the symptoms of constipation and irritable bowel syndrome, or IBS—was recalled from the United States market on March 30, 2007 after data revealed a link between the drug and a number of serious side effects. According to the Zelnorm recall, the drug may cause heart attack, stroke, severe diarrhea and related complications, ischemic colitis and/or other gastrointestinal effects . Unfortunately, this dangerous product has been used by hundreds of thousands of Americans since its initial approval in 2002.
Individuals who have taken Zelnorm and suffered a serious adverse health effect may be able to hold Novartis liable for damages including medical costs, mental anguish, and more. To find out if you are eligible to recover your losses, please contact us today.
Zelnorm: Before the Recall
Prior to the Zelnorm recall in March 2007, the drug had been the subject of various regulatory actions including multiple labeling changes. In April 2004, the label was revised to warn patients of the risk of severe diarrhea and ischemic colitis. Then, several weeks before the Zelnorm recall, the drug's label was updated to include another potential adverse reaction—liver function changes.
A large-scale analysis of the medical records of more than 18,000 Zelnorm users prompted the final regulatory action, the recall, which was initiated by Novartis at the urging of FDA officials. The analysis specifically showed that the benefits of Zelnorm do not outweigh the risks, which include:
Patients who have experienced any of these adverse effects as a result of taking Zelnorm are urged to seek immediate medical attention and file a report with the FDA.
Protect Your Legal Rights
If you or someone you love has suffered serious injury or death because of Zelnorm, you need to ensure your legal rights are fully protected. You may be entitled to compensation for your losses and suffering. Please contact us today for a FREE, no obligation case evaluation with a qualified product liability attorney near you who can answer your questions and help you maximize your legal rights and options.