Sometimes when no comparable or satisfactory alternative drug or therapy is available, the FDA will allow patients with a serious or life-threatening disease or condition to be treated with an unapproved drug under very strict guidelines. Both doctor and patient must evaluate whether the benefits outweigh the risks. In the case of Zelnorm, patients will be required to sign consent materials to ensure they are fully informed of the potential risks and benefits.
In 2002, the FDA approved Zelnorm for the short-term treatment of women with IBS-C. Then on March 30, 2007, the drug was withdrawn from the U.S. market following a safety analysis consisting of 29 clinical studies of Zelnorm. In these studies, a total of 11,614 patients were treated with Zelnorm and 7,031 received a placebo. Thirteen of the participants taking Zelnorm (0.1%) had serious, life-threatening cardiovascular side effects, including angina, heart attacks, and stroke. One of the 13 died.
The FM, ME/CFS and IBS Connection
Irritable bowel syndrome is one of the more common comorbid or overlapping conditions that occurs with both fibromyalgia and chronic fatigue syndrome. The symptoms of IBS vary with the individual. Some experience excessive diarrhea; some have severe constipation; and others alternate between the two. Zelnorm is only used to treat the group of IBS patients who have severe constipation that is not improved by any other type of treatment.
Is Zelnorm for you?
If you and your doctor agree that your IBS-C is serious enough that the potential benefits outweigh the risks and you meet the criteria, your physician should contact Novartis at 888-669-6682 or 800-QUI-NTILE. If you do not qualify for the Zelnorm treatment protocol, you may contact FDA's Division for Drug Information about other possible options at 888-463-6332.
Read the FDA News Alert: “FDA Permits Restricted Use of Zelnorm for Qualifying Patients”