Zelnorm Risks:
March 30, 2007 – the Food and Drug Administration (FDA) issued a public health advisory warning the public regarding recent findings that Zelnorm (generic: Tegaserod) significantly increases the risk of adverse cardiac events such as heart attack and stroke. As a result of the increased risk of a Zelnorm heart attack or Zelnorm stroke the FDA requested that Novartis Pharmaceuticals stop marketing Zelnorm. The FDA is currently advising patients who are using Zelnorm to get in touch with their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care 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.
What is Zelnorm?
Zelnorm is a prescription drug approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation.
Zelnorm Safety Trials:
Safety data from 29 clinical trials involving over 18,000 patients showed that cardiovascular ischemic events occurred in 13 out of 11,614 patients treated with Zelnorm (0.11%), compared with one case in 7,031(0.01%) patients treated with a sugar pill they thought was Zelnorm. All patients affected had pre-existing cardiovascular disease and/or cardiovascular risk factors.
The sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm.
In its Public Health Advisory, the FDA made the following announcements, effective immediately:
- 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.
If you are currently taking Zelnorm and have concerns about its safety, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Zelnorm, without first consulting with your doctor.
If you or a loved one have experienced Zelnorm side effects such as severe chest pain, heart attack, or stroke you may be entitled to compensation. Contact the Zelnorm attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and attorneys are standing by to answer any questions you may have regarding Zelnorm side effects, a possible Zelnorm class action lawsuit, or any other type of Zelnorm litigation.
