Zelnorm Recall – FDA Recall Issued for Zelnorm (Tegaserod Maleate)

The safety of Zelnorm has recently come into question as a result of a series of clinical studies conducted to measure the efficacy of the drug. Of the 11,614 patients involved in the trials who were treated with Zelnorm, 13 experienced serious side effects. 

The serotonin agonist went through initial clinical trial testing prior to receiving FDA approval in 2002 for the treatment of a number of GI tract abnormalities, such as irritable bowel syndrome (IBS) and constipation predominant. The latest clinical trials (of which there were approximately 29) were designed to measure the effectiveness of the drug to provide treatment for various gastrointestinal conditions. It was determined that use of the drug may lead to an increased likelihood of heart attack, stroke and chronic chest pain. Safety of the drug was therefore called into question.

Zelnorm FDA Recall

The Food and Drug Administration responded to the discovery of serious Zelnorm side effects by issuing a recall request to Novartis AG, the Swiss pharmaceutical company responsible for development of the prescription medication. Although the serotonin agonist had previously been approved for public consumption, it was decided that the risks associated with use no longer outweigh the benefits. As such, a Zelnorm recall was requested.

The FDA advises Zelnorm users to consult with their physician to determine the best course of action in terms of treating their underlying GI tract condition in a safe and effective manner. There are a number of alternative drugs that may be recommended by physicians. Zelnorm users who experience signs of chest pain, dizziness, or shortness of breath, are advised to seek out medical assistance immediately.

Zelnorm Recall Lawsuits

Drug manufacturers are required to ensure the safety and efficacy of their products prior to marketing them to the public. Failure to adequately measure the risks associated with use of a drug is considered negligent and can be grounds for personal injury litigation. Zelnorm patients who have been injured as a result of using the drug are advised to consult with a personal injury lawyer to determine eligibility for filing a lawsuit. The law offices of Aylstock, Witkin, Kreis & Overholtz boast some of the most experienced personal injury attorneys Pensacola, Florida has to offer. Contact them today at 877 810 4808 to get more information.