Doctor’s Guide
News
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.
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
Available online:
http://www.docguide.com/news/content.nsf/news/852571020057
CCF6852572AE0061888F?OpenDocument&id=48DDE4A73E09A969852568880078C
249&c=Angina%20Pectoris%2fMI&count=10
