Zelnorm for IBS

[Guest guest]

IBS Drug Zelnorm Taken Off U.S. Market

FDA: Voluntary Withdrawal Due to Risk of Heart Attack, Stroke, Chest Pain

By _Todd Zwillich_ (http://www.webmd.com/Todd-Zwillich)

WebMD Medical News

Reviewed by _Louise Chang, MD_ (http://www.webmd.com/Louise-Chang)

March 30, 2007 -- A popular drug for irritable bowel syndrome and

constipation was pulled from the U.S. market Friday amid new evidence that it

raises

the risk of heart attacks and strokes.

Novartis, the manufacturer of Zelnorm, confirmed that Food and Drug

Administration officials asked for the drug’s withdrawal.

Agency officials said they based their decision on a Swiss government

analysis of 29 Zelnorm studies that showed a higher chance of cardiovascular

events, such as heart attack, stroke, or severe heart-related chest pain in

patients treated with Zelnorm compared with those given a placebo.

The analysis turned up 13 cases of heart attack, stroke, or angina (chest

pain related to heart disease) in about 11,600 patients who took the drug. One

of the 13 died, the agency said. This was compared with just one nonfatal

event in more than 7,000 patients who took the placebo.

, MD, head of the FDA’s Office of New Drugs, described the

overall number of dangerous events as “quite small.†But he said the rate of

cardiovascular events -- about 10 times higher in patients taking Zelnorm --

raised alerts about the drug.

“Based on our review of the data we believed that the risk vs. benefit

profile for Zelnorm was no longer favorable,†told reporters on a

conference call.

He said patients taking Zelnorm should speak immediately to their doctors.

Special Access to Zelnorm

Though the drug will no longer be widely available, patients who have no

other treatment options could still get access to the drug. The FDA said it is

likely to allow Novartis to continue selling Zelnorm to patients if their

doctors say they have disease that does not respond to any other treatment and

if

the benefits of treatment with Zelnorm outweigh the risks of serious side

effects. Drug access would be done through a special program.

The FDA says it has told Novartis that it's willing to consider limited

reintroduction of Zelnorm at a later date if a population of patients can be

identified in whom the benefits of the drug outweigh the risks.

However, before the FDA makes a decision about limited reintroduction, any

proposed plan would be discussed at a public advisory committee meeting.

In a statement, Novartis maintained that no evidence proves that Zelnorm

caused heart attack or strokes and that event rates were not significantly

different from those in the general population. But the company confirmed it

would

pull Zelnorm from the market.

“Novartis has suspended the marketing, sales, and distribution of Zelnorm in

response to the FDA's request,†the statement read.

Novartis is a WebMD sponsor.

Zelnorm was approved for short-term treatment of women with irritable bowel

syndrome (IBS) with constipation and for patients younger than 65 years with

chronic constipation.

Are you taking Zelnorm? Talk about it _on the WebMD message boards._

(http://boards.webmd.com/webx?THDX@@.89531f86!thdchild=.89531f86)

<

SOURCES: , MD, director, Office of New Drugs, Food and Drug

Administration. Novartis press statement, March 30, 2007. FDA: " Public Health

Advisory: Tegaserod maleate (marketed as Zelnorm). "

************************************** See what's free at http://www.aol.com.