Zelnorm Side Effects
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Zelnorm Side Effects
Zelnorm was brought to market by Novartis Pharmaceuticals in 2002. The drug is designed to provide short term relief to women who suffer from irritable bowel syndrome (IBS) and are have difficulties with constipation and bloating. Since its introduction Zelnorm’s list of side effects has grown steadily longer.
In 2004, the FDA insisted that (along with severe diarrhea) an additional Zelnorm side effect be added to the warning on the packaging: that is ischemic colitis. Ischemia generally means the restriction of blood flow to a particular area of the body. The warning for Zelnorm-induced ischemic colitis stated that patients should immediately stop taking the drug if they develop rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. These are symptoms of intestinal ischemia in which the supply of blood and oxygen to the intestines are compromised.
In March of 2007, the FDA asked Novartis to cease marketing the product and remove it from the marketplace. The Zelnorm side effect that prompted this decision was an increase in “cardiovascular incidents” which meant strokes, angina or heart attacks. The evidence was taken from a review of 18,000 patients who participated in clinical trials for the drug. While the evidence of increased cardiovascular incidents among Zelnorm users was a very low number of patients, it was an additional indication that Zelnorm side effects may include reduced blood flow to areas of the body in addition to the intestine.
Zelnorm’s severe side effects have resulted in a number of product liability suits. If you have used the drug and feel you may have a case, let us provide you with a free, in-depth analysis.
