Zelnorm

Zelnorm Withdrawn from Market

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals discontinue sales of Zelnorm due to serious side effects such as heart attack and stroke. The manufacturer will be allowed to continue use of the drug for investigational purposes only.

What is Zelnorm?

Zelnorm is the brand name for tegaserod maleate, a prescription drug used to treat Irritable Bowl Syndrome (IBS) and chronic constipation. Zelnorm was approved by the FDA to treat IBS in women in 2002, and constipation for both men and women in 2004.

Possible Side Effects of Taking Zelnorm

Angina
Diarrhea
Heart Attack
Intestinal Inflammation
Stroke
In some serious cases, death

Overview of Zelnorm

During the initial marketing of Zelnorm from August 2002 until March 2004, nearly 50 cases of serious complication were reported. These reports showed serious side effects such as severe diarrhea, ischemic colitis (intestinal inflammation), and intestinal ischemia (restriction of blood flow to the digestive organs).

The FDA’s approval of Zelnorm was expanded in August 2004 from treating women with IBS to providing relief for both men and women suffering from constipation. But the FDA does not consider Zelnorm a cure for IBS, and they have found no evidence that it works to treat IBS in men.

In early 2007, Novartis reported the results of several short-term clinical trials to the FDA. Serious risks such as heart attack and stroke occurred more frequently in patients taking Zelnorm than in patients taking a placebo. Based upon these findings, the FDA suggested that the drug be withdrawn from the market.

Our Lawyers Understand Dangerous Drug Cases

If you, or someone you care about, were hurt because of taking Zelnorm, you need to act quickly. When our law firm gets involved with your case, we immediately get to work investigating the cause of your drug reaction and fighting for your legal rights to fair compensation.

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