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FOR IMMEDIATE RELEASE
P07-55
March 30, 2007
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Media
Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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FDA
Announces Discontinued Marketing of GI Drug, Zelnorm, for
Safety Reasons
The Food and Drug Administration (FDA) has requested that
Novartis Pharmaceuticals Corporation of East Hanover, New
Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod)
based on the recently identified finding of an increased risk
of serious cardiovascular adverse events (heart problems)
associated with use of the drug. Novartis has agreed to
voluntarily suspend marketing of the drug in the United
States.
Zelnorm is a prescription medicine approved in July 2002
for short-term treatment of women with irritable bowel
syndrome whose primary symptom is constipation. It was
subsequently approved in August 2004 for treatment of chronic
constipation for men and women under age 65. Zelnorm is
marketed in 55 countries.
FDA is currently advising patients who are using Zelnorm to
contact their health care providers to discuss treatment
alternatives. Patients who are taking Zelnorm should seek
emergency medical care 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.
"This decision reflects the FDA's commitment to
continuously monitor approved drugs throughout their marketing
life, and take action when we believe the risks exceed the
benefits," said Dr. Douglas Throckmorton, Deputy Director for
the Center for Drug Evaluation and Research. "Here, a
potential risk of very serious harm to patients who have this
non-life-threatening condition was recently identified, making
this action necessary."
Throughout February and March 2007, Novartis reported to
FDA the results of a new analysis of 29 short-term (1 - 3
months) randomized, controlled clinical trials of Zelnorm. FDA
has concluded, based on these data that for most patients the
benefits of this drug no longer outweigh the risks.
The analysis included more than 11,600 patients treated
with Zelnorm and over 7000 patients treated with placebo. The
data showed that the risk of serious cardiovascular adverse
events (e.g., angina, heart attacks, and strokes) associated
with use of Zelnorm is higher than with placebo treatment.
Thirteen Zelnorm-treated patients (or 0.1%) had confirmed
cardiovascular ischemic events, and only 1 placebo-treated
patient (or 0.01%) with an event.
FDA will work with Novartis to allow access to Zelnorm as
an investigational drug for patients with no other treatment
options where the benefits may outweigh the risks. FDA has
also indicated to Novartis the possibility of considering
limited re-introduction of Zelnorm at a later date if a
population of patients can be identified in which the benefits
of the drug outweigh the risks. Any such proposal would be the
subject of a public advisory committee meeting before an FDA
decision.
For more information, visit
http://www.fda.gov/cder/drug/advisory/tegaserod.htm
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