ZELNORM AND HEART ATTACKS AND STROKES

Zelnorm, a widely prescribed drug for severe constipation, is being taken off the market after it was linked to a risk of heart attacks and strokes, the FDA said Friday, March 30, 2007.

The Food and Drug Administration asked for the withdrawal of Zelnorm after an analysis of 29 studies involving more than 18,000 patients found that those who took the medication had significantly higher rates of cardiac problems than those who were given a sugar pill.

John Jenkins, head of the FDA's office of new drugs, said the differences between patients on Zelnorm and those given a sugar pill were significant. He said 13 Zelnorm patients suffered heart attacks, chest pain or strokes, and one died. Of those on sugar pills, one had symptoms of a stroke that went away. None died.  He stated: "We concluded that the benefits of this drug no longer outweighed the risks."

Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.

What is Zelnorm (tegaserod maleate)?

Zelnorm is a medicine used for the short-term treatment of women who have irritable bowel syndrome with constipation (IBS-C) as their main bowel problem. IBS is a disorder that interferes with the normal functions of the large intestine (colon). Symptoms may include cramps, abdominal pain, bloating, constipation, and/or diarrhea. The cause of IBS is not known. Zelnorm works by increasing the movement of stools through the bowels.

What is Zelnorm approved for?

Zelnorm was approved on July 24, 2002, for short term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.  Novartis knew as early as 2002 that Zelnorm caused angina pain , yet the company failed to warn consumers.
 

What should I do if I am currently taking Zelnorm?

The FDA encourages those people who are taking Zelnorm to contact their doctor and discuss appropriate alternative treatments.

Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.

If you have suffered a heart attack, stroke or angina pain and you took Zelnorm, please contact us today to protect your interests.

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