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Senior Citizen Alerts
Zelnorm Popular GI Drug Stops Marketing, Says
FDA
Company agrees to voluntary suspension due to
heart risks but hopes for comeback
 March
30, 2007 The Food and Drug Administration (FDA) announced today it has
requested, and Novartis Pharmaceuticals agreed, that marketing of
Zelnorm (tegaserod) should be discontinued. Novartis said it would
suspend marketing of the drug in the U.S. based on the recently
identified finding of an increased risk of serious cardiovascular
adverse events (heart problems) associated with use of the drug.
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Senior Citizen Alerts |
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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."
On its Website, Novartis says, "Patients who are
taking Zelnorm should speak with their doctor about other appropriate
treatment options. Patients can return any unused and unexpired Zelnorm
tablets to Novartis for reimbursement of out-of-pocket costs. More
information can be obtained by calling the Novartis Customer Interaction
Center at 888-NOW-NOVA (888-669-6682).
"Novartis believes that Zelnorm provides important
benefits for appropriate patients with irritable bowel syndrome with
constipation. We will discuss with the FDA the best way to continue to
make this medication available to patients."
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.
The 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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