A: 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.
http://www.fda.gov/cder/dr
ug/advisory/tegaserod.htm
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.
http://www.fda.gov/cder/dr
ug/advisory/tegaserod.htm
Tegaserod maleate (marketed as Zelnorm)
FDA announces the following, effective immediately:
What is Zelnorm?
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.
Results of clinical study on Zelnorm
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
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 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.
What is Zelnorm?
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.
Results of clinical study on Zelnorm
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.
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indirectly, of the use and application of any of the contents of this site.
intended to provide helpful and informative material on the subjects
addressed. It is written with the understanding that the author(s) is (are) not
engaged in rendering medical, health, or any other kind of professional
service(s). The reader should consult his or her medical, health or other
competent professional before adopting any of the suggestions. The
author(s) specifically disclaim all responsibility for any liability, loss, or risk,
personal or otherwise, which is incurred as a consequence, directly or
indirectly, of the use and application of any of the contents of this site.
Q: Why is Zelnorm taken off the Market by the FDA?