Prescription GI drug taken off market
NEWS IN BRIEF — Posted April 23, 2007
At the request of the Food and Drug Administration, Novartis Pharmaceuticals has stopped marketing Zelnorm (tegaserod maleate) because of an increased risk of heart problems associated with its use.
This drug was approved in July 2002 for the short-term treatment of women with irritable bowel syndrome whose main symptom was constipation. In August 2004, it was also given the nod to treat chronic constipation in patients of both sexes who were younger than 65.
"A potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary," said Douglas Throckmorton, MD, deputy director of for the FDA's Center for Drug Evaluation and Research.
The company questioned the link between the drug and cardiovascular events, and the drug will continue to be available on an investigational basis for patients with no other treatment options where the benefits may outweigh the risks.
The door has also been left open for a limited reintroduction.
"Although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients," said James Shannon, MD, global head of development at Novartis.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/04/23/hlbf0423.htm.