Drug Recall: Zelnorm Production Suspended by FDA

On March 30, 2007 marketing of the recently popular drug, Zelnorm, came to a screeching halt. The FDA announced the Novartis Pharmaceuticals Corporation had put a stop to the marketing of the drug after studies showed an apparent increase in the risk of heart attack and stroke.

Zelnorm (generic name: tegaserod) was approved by the FDA in July 2002 for the short-term treatment of women suffering from Irritable Bowel Syndrome with a main symptom being constipation. The product also has been shown to provide significant relief from the symptoms of abdominal pain and bloating associated with IBS. After much success with this indication, the FDA allowed an additional use. In August 2004, the drug became indicated for use in both men and women under the age of 65 for the treatment chronic constipation. After only 4 years on the market, more than 500,000 patients in the United States are currently using the product. The drug is being marketed in over 50 countries and is known as Zelmac in many of those countries.

Patients being treated with this product are encouraged to contact their healthcare provider to discuss their options regarding use of this drug. Also, if they experience any form of chest pain, shortness of breath, dizziness, trouble speaking or walking, weakness, or any other sign of a heart attack or stroke, they should receive emergency treatment right away.

Healthcare providers should attempt to discuss this issue with patients currently taking Zelnorm and switch them to other medications if needed for their individual situation. There may be patients that have no other effective treatment alternatives. In these patients, the chance of these side effects is outweighed by the potential benefit of this treatment. The FDA will work with Novartis Pharmaceuticals Corporation to examine the potential of setting up a program specifically for these patients so that better monitoring can take place. Also, if a certain patient population is identified in which the benefit of Zelnorm outweighs any risk, the FDA may consider limited re-introduction of this product to these patients only. These options will occur only after much further study.

At this time, Novartis is offering a refund to patients in exchange for any unused tablets. The company can be contacted for full details at the Customer Interaction Center at (888) 669-6682 to obtain the Zelnorm Consumer Product Return Form and a postage paid envelope. Patients must return this form along with their unused and unexpired tablets and prescription receipt by September 30, 2007. Refunds will be received 4-6 weeks after all information is received.