FDA Permits Restricted Use of Zelnorm for Qualifying Patients
Originally suspended for being linked to increased risks of heart attack, stroke, and angina, Zelnorm (tegaserod malete) has been approved by the FDA to be used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55.
Irritable bowel syndrome is a gastro-intestinal disorder characterized by bloating, constipation, abdominal pain, and diarrhea. While IBS causes discomfort, it is not known to cause permanent harm nor lead to disease. For many sufferers, however, IBS can be disabling.
Under age and gender restrictions, Zelnorm may be marketed as relieving the symptoms associated with IBS.
On March 30, 2007, Novartis, the manufacturer of Zelnorm, was asked by the FDA to suspend its U.S. marketing and sales because of health risks found to be associated with Zelnorm, including stroke, heart attack, and angina (chest pain).
Despite this allowance for restricted use, the Zelnorm lawyers of AWKO remain committed to seeking justice for those who have been injured by Zelnorm, including handling cases for Zelnorm heart attack and Zelnorm stroke.
Zelnorm Side Effects – Recall Lawsuits
Swiss pharmaceutical juggernaut Novartis AG has issued a voluntary recall of Zelnorm (tegaserod maleate) in compliance with a request by the Food and Drug Administration (FDA). The serotonin agonist was first approved by the FDA back in 2002 after undergoing clinical trial testing engineered to measure drug efficacy.
Zelnorm is a prescription drug designed to counter the bothersome effects associated with constipation. The drug has also been prescribed to some women for the short-term treatment of irritable bowel syndrome and for patients under the age of 65 suffering from chronic constipation. Although the FDA has been quick to admit that the risk of serious side effects is extremely rare, they believe that the benefits of treatment with the drug no longer outweigh the risks.
Zelnorm Side Effects – Heart Attacks and Strokes
The FDA decision to issue a Zelnorm recall request followed the results of approximately 29 clinical studies conducted to measure the efficacy of Zelnorm in treating a series of GI tract conditions. There were 18,645 patients involved in the study, 11,614 of which were treated with Zelnorm. The remaining patients were separated into a control group and issued a placebo.
Of the 11,614 patients treated with Zelnorm, 13 experienced serious side effects. These patients were victimized by a variety of cardiovascular side effects, including:
- Heart attack, and
- Worsening chest pain capable of resulting in heart attack
Only one of the patients issued a placebo suffered any such cardiovascular problem.
The risks associated with Zelnorm concerned the FDA to the extent that it worked in conjunction with Novartis AG to pull the widely-advertised drug from the marketplace on March 30, 2007. The FDA has communicated to Novartis that Zelnorm may possibly be reintroduced to the marketplace if further clinical testing concludes that the benefits of Zelnorm use outweigh the risks for certain populations.
Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for public consumption. Failure to do so is considered negligent and grounds for pharmaceutical litigation. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. They have successfully represented and obtained substantial compensation for a number of patients who have been harmed by drugs. Contact AWKO law today at (844) 794-7402 to get more information about your rights as a Zelnorm injury victim.
More information > Zelnorm Recall – FDA Recall Issued for Zelnorm (Tegaserod Maleate)
On May 3rd, Neil Overholtz attended and served as a faculty member at the Mealey’s Emerging Drug and Medical Device Litigation Conference in San Diego, California, where he presented the Plaintiff’s perspective on the Permax valve disease cases, including providing an educational presentation on the science and liability issues in the case. Mr. Overholtz also presented initial information on the emerging litigation involving Zelnorm heart attack and Zelnorm stroke cases. Mr. Overholtz is co-chairing the upcoming Mealey’s teleconference on the Zelnorm lawsuits on May 17th.