Zelnorm was used to treat severe, chronic irritable bowel syndrome (IBS) in women who were found to have constipation as their main bowel problem. Unfortunately, Zelnorm was found to have serious side effects and was withdrawn from the US market on March 30, 2007. Zelnorm may still be used in limited emergency situations.
At the time it was removed from the market, Zelnorm was one of the 200 most prescribed brand-name medications in the United States, with over 2.6 million prescriptions written during 2006 alone. Sales were $561 million worldwide in 2006.
Side Effects of Zelnorm
Zelnorm has serious side effects. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience:
- Severe Chest Pain
- Shortness of breath
- Sudden onset of weakness
- Difficulty walking or talking
- Rectal bleeding
- Bloody diarrhea
- Abdominal Pain
These side effects could lead to angina, heart attack, stroke or intestinal ischemia (supply of blood and oxygen to the intestines are compromised) and should be taken seriously.
History of Zelnorm
March 2001 - Public Citizen, a consumer watchdog group, files a petition to have Zelnorm's FDA approval blocked.
July 2002 - Zelnorm approved by the FDA for use by women who suffer from IBS Constipation.
April 2004 - FDA Updates Zelnorm's labeling information to include a warning about the risk and consequences of severe diarrhea, including loss of consciousness, dehydration, and decreased blood pressure. At this time, a new precaution was added to the labeling about the risk of ischemic colitis (inflammation of the colon caused by decreased blood flow to the intestines).
August 2004 - The FDA grants Zelnorm a supplemental indication for the treatment of chronic idiopathic constipation in male and female patients less than 65 years of age.
December 2005 - The European Union refused to accept Zelnorm as a medication for Irritable Bowel Syndrome.
March 2006 - The European Medicines Agency rejected approval of the 6 mg Zelnorm tablet for a second time, concluding that, "Zelnorm's benefits are not greater than its risks."
March 30, 2007 - Novartis Pharmaceuticals agreed to the US FDA and Health Canada's request to voluntarily discontinue marketing and sales of Zelnorm. The request was based on an analysis of 11,600 patients treated with Zelnorm. About 1 in 1,000 of these users experienced serious cardiovascular adverse events. These heart problems occurred about 7 times more often than those who took just a placebo.