Zelnorm

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Zelnorm was approved for sale in the United States in 2002 to treat severe, chronic, irritable bowel syndrome (IBS) in women who have constipation as their main bowel problem (constipation-predominant). Zelnorm increases the action of serotonin in the intestines which speeds the movement of stools through the bowels.

Common side effects observed in patients using Zelnorm include:

• Headache
• Abdominal pain
• Diarrhea
• Nausea
• Dizziness

On March 30, 2007, at the request of the United States Food and Drug Administration (FDA), pharmaceutical manufacturer Novartis AG announced a recall of Zelnorm. The FDA’s request came after studies indicated a high risk of heart attack or stroke for patients on the drug.

John Jenkins, director of the FDA’s Office of New Drugs, said in a statement that the FDA believed “the risk versus benefit profile for Zelnorm was no longer favorable.”

An analysis of 11,600 patients involved in 29 clinical studies of Zelnorm showed a higher rate of heart attacks, strokes, and related heart problems while on the drug. Thirteen patients in the studies had serious cardiovascular side effects while on Zelnorm, including:

• Four patients who suffered heart attacks,
• Three patients who suffered strokes,
• Six patients who had angina, or severe chest pain which can quickly progress to cardiac arrest, or heart attack, and
• One patient who died while on the medication.

Sources: Eva von Schaper, “Novartis Stops Zelnorm Marketing, Sales on Heart Risk,” Bloomberg.com, March 30, 2007; Jennifer Corbett-Dooren and Goran Mijuk, “Novartis to Suspend U.S. Sales of Zelnorm on FDA Request,” Wall Street Journal, March 30, 2007; “Questions and Answers on Zelnorm,” Food and Drug Administration, April 2, 2007.

Zelnorm recall warns of heart problems

On March 30, 2007, Novartis AG recalled Zelnorm at the request of the U.S. Food and Drug Administration. The FDA’s request came after studies indicated a high risk of heart attack or stroke. John Jenkins, director of the FDA’s Office of New Drugs, said in a statement that the FDA believed “the risk versus benefit profile for Zelnorm was no longer favorable.”

Sources: Eva von Schaper, “Novartis Stops Zelnorm Marketing, Sales on Heart Risk,” Bloomberg.com, March 30, 2007; Jennifer Corbett-Dooren and Goran Mijuk, “Novartis to Suspend U.S. Sales of Zelnorm on FDA Request,” Wall Street Journal, March 30, 2007; “Novartis Suspends US Marketing and Sales of Zelnorm in Response to Request from FDA,” Novartis Pharmaceuticals Corporation, March 30, 2007.

What should Zelnorm patients do now?

Zelnorm was approved in 2002 for the short-term treatment of irritable bowel syndrome with constipation, or IBS-C. In 2004, FDA approved the marketing of Zelnorm for chronic idiopathic constipation. Patients who have taken Zelnorm and experience any of the following side effects should get emergency medical treatment right away, as they may indicate the onset of heart attack and stroke:

• Severe chest pain, sometimes radiating down the arm;
• Shortness of breath;
• Dizziness;
• Sudden onset of weakness;
• Difficulty walking; or
• Difficulty talking.

Call a Zelnorm Lawyer Today – Free Call, No Obligation

If you or someone you love has been taking Zelnorm to treat constipation and have experienced angina or severe chest pain, congestive heart failure, heart attack, or other adverse cardiovascular events, the FDA and Novartis have issued a recall. Contact our personal injury law firm today.

A consultation with a product liability lawyer may be in your best interest. If Novartis knew the risks of taking Zelnorm were more dangerous than it originally claimed, you may be entitled to compensation for the injuries you may have suffered as a result. Our lawyers are investigating the circumstances of this case. Your information will be reviewed by a lawyer who may be able to help you gain compensation from a Zelnorm lawsuit.