Novartis Voluntarily complies with FDA Recall of Zelnorm

Silver Spring, MDA drug prescribed to treat certain aspects of Irritable Bowel Syndrome has been pulled from U.S. shelves over concerns regarding increased risk of heart attack and stroke in patients taking the drug. A recent study, together with a death in Portland, prompted the United States Food and Drug Administration (FDA) to act.

Zelnorm has been linked to the death of an otherwise healthy 56-year-old woman with no known heart problems in her own prior medical, or family history.

Approved by the FDA in 2002 and marketed by Novartis Pharmaceuticals, a Swiss-based manufacturer, Zelnorm is the trade name for tegaserod maleate, a drug prescribed to ease the suffering of patients with irritable bowel syndrome - and specifically, the severe constipation side of the disease. Zelnorm, intended for use only by women, eases the passage of stools through the colon.

Irritable bowel syndrome is a disease affecting mostly women. Little is known about its causes. To the millions of Americans who suffer from this debilitating disease, however, relief from the often intense abdominal pain and stool complications (diarrhea or constipation - or both) has been hard to come by. Zelnorm had been considered a welcome therapy, until studies by the manufacturer and voluntarily submitted to the FDA, revealed serious cardiovascular side effects in 13 study patients.

In Oregon, a woman who had been taking Zelnorm regularly since 2003 went into sudden cardiac arrest, and doctors in Portland could not stabilize her. She passed away on what would have been her 56th birthday.

In complying with FDA recommendation to halt sales of the drug in the United States, Novartis Pharmaceuticals is taking a U.S. $488 million dollar hit, which represents American sales of Zelnorm in 2006. While the FDA ruling has no jurisdiction within some 55 other counties selling the drug, a handful are following the U.S. lead and are pulling Zelnorm: among them Australia, Canada, Singapore and Barbados.

Patients currently taking Zelnorm have been urged to contact their doctor for the next step, which may or may not include transition to a different medication. Users of Zelnorm who experience severe chest pain or other cardiovascular irregularities should seek emergency treatment immediately.

As for the husband of the woman who died after taking Zelnorm for three years, he says his wife had been to see her doctor just a few days before suffering the heart attack, and all was well. There was no sign of pending cardiovascular complication.

The manufacturer, while voluntarily complying with the FDA recall, stands behind its product.