Zelnorm being pulled

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FDA: Zelnorm Being Pulled From Market

ROCKVILLE, MD -- March 30, 2007 -- FDA is issuing this public health

advisory to inform patients and health care professionals that the

sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals

Corporation, has agreed to stop selling Zelnorm. Zelnorm is being taken

off the market because a new safety analysis has found a higher chance

of heart attack, stroke, and worsening heart chest pain that can become

a heart attack in patients treated with Zelnorm compared to those

treated with a sugar pill they thought was Zelnorm.

FDA announces the following, effective immediately:

· At FDA's request, Novartis Pharmaceuticals Corporation has agreed

to stop selling Zelnorm.

· Patients being treated with Zelnorm should contact their physician

to discuss alternative treatments for their condition.

· Patients who are taking Zelnorm should seek emergency medical care

right away if they experience severe chest pain, shortness of breath,

dizziness, sudden onset of weakness or difficulty walking or talking or

other symptoms of a heart attack or stroke.

· Physicians who prescribe Zelnorm should work with their patients

and transition them to other therapies as appropriate to their symptoms

and need.

Zelnorm is a prescription medication approved for short term treatment

of women with irritable bowel syndrome with constipation and for

patients younger than 65 years with chronic constipation. In late

February and early March 2007, Novartis Pharmaceuticals gave FDA the

results of new analyses of 29 clinical studies of Zelnorm for treatment

of a variety of gastrointestinal tract conditions; the data from all the

studies were combined to assess the chance of side effects on the heart

and blood vessels. In each study, patients were assigned at random to

either Zelnorm or a sugar pill they thought was Zelnorm. These 29

studies included 11,614 patients treated with Zelnorm and 7,031 treated

with a sugar pill. The average age of patients in these studies was 43

years and most patients -- 88% -- were women.

The number of patients who suffered a heart attack, stroke or severe

heart chest pain that can turn into a heart attack was small. However,

patients treated with Zelnorm had a higher chance of having any of these

serious and life-threatening side effects than did those who were

treated with a sugar pill. Thirteen patients treated with Zelnorm (0.1%)

had serious and life-threatening cardiovascular side effects; among

these, four patients had a heart attack (one died), six had a type of

severe heart chest pain which can quickly turn into a heart attack, and

three had a stroke. Among the patients taking the sugar pill, only one

(or 0.01%) had symptoms suggesting the beginning of a stroke that went

away without complication.

There may be patients for whom no other treatment options are available

and in whom the benefits of Zelnorm treatment outweigh the chance of

serious side effects. FDA will work with Novartis to allow access to

Zelnorm for those patients through a special program.

FDA has also indicated to Novartis a willingness to consider limited

re-introduction 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 FDA makes a decision about limited re-introduction, any

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

SOURCE: FDA