Zelnorm (Tegaserod Maleate) is a prescription medication manufactured by Novartis Pharmaceuticals that until recently was prescribed to treat irritable bowel syndrome and severe constipation. The drug's manufacturer was recently ordered by the FDA to stop marketing Zelnorm based on findings that the medication has been associated with severe and life-threatening cardiovascular side effects.
The results of multiple clinical studies of more then 18,000 patients has shown that users of Zelnorm had a higher chance of heart attack (myocardial infarction), severe chest pain (angina) and stroke. Following the release of these results and a request by the FDA to stop selling the drug, Novartis Pharmaceuticals immediately pulled Zelnorm from the market. To date, there have been nearly two dozen reports of severe intestinal side effects to the FDA, however the true scope of the danger surrounding the drug is still unknown.
The FDA has requested the following:
- Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
- Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.
- Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.
Early Signs of Severe Side Effects:
On April 29, 2005 the FDA and Novartis Pharmaceuticals notified healthcare professionals of changes to the warnings and precautions sections of labeling for Zelnorm. The warning referred to serious consequences of diarrhea (including hypovolemia, hypotension, and syncope) that occurred both during clinical trials and during marketed use, in some cases requiring hospitalization.
On April 28, 2004 the FDA and the Food and Drug Administration (FDA) announced the addition of serious new risk information to the health professional labeling for Zelnorm. The specific revisions include:
- A new warning about the serious consequences of diarrhea associated with the medication
- A new precaution about ischemic colitis and other forms of intestinal ischemia (reduced blood flow to the intestines)
- Changes to the adverse reactions section describing post-marketing reports
- New information in the "Information for the Patient" leaflet
More about Irritable Bowel Syndrome (IBS)
IBS or "spastic colon" is a common ailment of the bowel (intestines) that affects nearly 15% of the population in the United States. The condition is characterized by abdominal pain and continuous changes in bowel habits. The type of pain felt by the patient is classified as diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) or IBS with alternating stool pattern (IBS-A).
If you or a loved one have experienced any serious side effects from the defective drug Zelnorm, please call us at 1.800.966.4999 or fill out the form to the right of the page for immediate attention to your case.
