Friday, March 30, 2007

FDA Requests Novartis' IBS Drug Zelnorm Be Taken Off Market Because of Cardiovascular Risk

Article in the Wall Street Journal -- Novartis to Suspend U.S. Sales Of Zelnorm on FDA Request, by Anna Wilde Mathews and Jeanne Whalen.  Here's an excerpt:

Novartis AG said it will suspend U.S. sales of Zelnorm, a drug for irritable-bowel syndrome, because of an apparent link to risks including angina, heart attacks and strokes.

Zelnorm is the second drug in as many days to come off the market for safety reasons at the request of the Food and Drug Administration, whose handling of drug risks is under close scrutiny from Congress. FDA officials said the timing was coincidental, and the agency's request for the Zelnorm sales halt was based on a finding that the evidence of danger outweighed the benefits. Zelnorm is prescribed for patients with severe constipation from the bowel syndrome or other causes.

"We believe that the risk versus benefit profile for Zelnorm was no longer favorable," said John Jenkins, the head of the agency's office of new drugs. The FDA will work with Novartis on a program that could lead to limited availability of the drug for people with no other treatment options, and might consider allowing it back on the market with restrictions, he said. When Lotronex, an earlier drug for a different type of irritable bowel syndrome, was pulled from the market, patients successfully lobbied for its return.

Here's a link to the article in the Washington Post.

BGS

http://lawprofessors.typepad.com/mass_tort_litigation/2007/03/fda_requests_no.html

FDA | Permalink

TrackBack URL for this entry:

http://www.typepad.com/services/trackback/6a00d8341bfae553ef00d83542ab0d53ef

Listed below are links to weblogs that reference FDA Requests Novartis' IBS Drug Zelnorm Be Taken Off Market Because of Cardiovascular Risk:

Comments

Post a comment