Patients Advised to Stop Taking Zelnorm If They Experience Certain Symptoms

FDA Updates Zelnorm Labeling with New Risk Information

WASHINGTON, D.C. — June 18, 2004 — Novartis Pharmaceuticals must add new warnings to the labeling for its drug Zelnorm (tegaserod maleate), which is used to treat a form of irritable–bowel syndrome in women that results in stomach bloating and constipation. Some patients taking Zelnorm developed severe diarrhea and required hospitalization, according to the Food and Drug Administration (FDA). Others developed intestinal problems such as ischemic colitis, an inflammation caused by interference with the blood flow to the large intestine.

The FDA has told Novartis to add new Zelnorm labeling information for both doctors and patients. Patients will be told to stop taking Zelnorm and to consult their doctors if they get new or worse stomach bloating. They should also stop the medication and see their doctors as soon as possible if they develop diarrhea and become dizzy, light–headed, and faint.

From the time of Zelnorm’s initial marketing in the United States in August 2002 until March 2004, the FDA received reports about patients who experienced serious health problems after taking the drug. These included 21 patients taking Zelnorm who suffered severe diarrhea and dehydration, 20 patients who developed ischemic colitis, and 3 patients diagnosed with other types of intestinal diseases. Some had to undergo surgery, and some died.

The FDA says that it is updating the labeling to inform patients and doctors of new risk information, although it has not yet definitively established that Zelnorm causes ischemic colitis. The agency does state that Zelnorm can cause severe diarrhea that can lead to hospitalization. The agency notes that “a determination by FDA that a drug is safe and effective does not mean that the drug is risk free. FDA will approve a drug if it determines that the benefits of the drug exceed the risks for the approved use as directed by the labeling”.

At Brayton Purcell, we have found that although the FDA oversees the drug manufacturing process, the agency’s approval of a specific drug does not always guarantee that it is safe. In fact, the FDA may pull a harmful drug off the market after it has already caused significant damage to patients. If you feel that your health has been effected by an unsafe drug and have questions about your legal rights, please feel free to contact us. We have been representing injured consumers and their families for over 20 years and are very knowledgeable in the medical/legal area.