Zelnorm Recall
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Zelnorm Recall
Zelnorm was introduced to the market in 2002 as a treatment for irritable bowel syndrome (IBS) in women. It was targeted principally at IBS symptoms of constipation and the resultant bloating. At the time of its introduction, the product was known to produce side effects in some users that included diarrhea and dizziness. The FDA signed off on the product introduction with label warnings about the side effects and limited its use to women.
Zelnorm began its market history with a list of potential side effects, as most drugs do. However prior to Zelnorm’s recall evidence surfaced of additional potential side effects, some potential life threatening. In 2004, prior to the Zelnorm recall, the FDA required an additional product warning on the label and in medical literature citing the prospect of ischemic colitis as a Zelnorm-induced IBS problem. Ischemic colitis occurs as the result of restricted blood flow to the intestine and manifests itself as an elevated attack of IBS that may include bloody diarrhea and increased abdominal pain.
The FDA mandated the Zelnorm recall in March of 2007. The Agency cited studies of patient data that indicated the potential for increased cardiovascular incidents among Zelnorm users. At that time, the drug’s manufacturer – Novartis Pharmaceuticals – maintained that the number of patients in the study that suffered cardiovascular difficulties was small and that each patient had a history of cardiovascular health problems.
The Zelnorm recall has led to a number of product liability suits from patients who have suffered one or more of the drug’s many side effects. If you feel you may have a similar case, let one of our professionals in the medical/legal field give you a thorough analysis of your case, free of charge.
