Zelnorm Recall
March 30, 2007Zelnorm withdrawn by Novartis
Novartis Pharmaceuticals has withdrawn its popular irritable bowel syndrome drug Zelnorm at the request of the Food and Drug Administration. The agency asked Novartis to stop sales and marketing of Zelnorm after studies revealed that it could lead to an increased risk of cardiovascular problems.
Zelnorm was approved by the FDA in 2002 for the short-term treatment of women with constipation caused by irritable bowel syndrome. Although studies have indicated that Zelnorm loses its effectiveness after three months of therapy, it was approved to treat both men and women with chronic constipation two years later.
In February of this year, Novartis informed the FDA of the results of 29 studies it had conducted on Zelnorm. These studies revealed that patients taking the drug were roughly eight times as likely to suffer heart attack, stroke or other cardiovascular problems as patients who were given a placebo. After reviewing this information on the risk of Zelnorm side effects, the FDA asked Novartis to take the drug off the market.
Dr. Douglas Throckmorton of the FDA says the agency decided that the risk of Zelnorm side effects outweighed the potential therapeutic benefits of the drug. “Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary.”
The FDA says that doctors should prescribe alternative treatments to patients who had previously been taking Zelnorm. Patients who were taking Zelnorm and who experience chest pain, dizziness, shortness of breath, sudden weakness or difficulty speaking or walking should seek medical attention immediately.