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BY OUR PHARMA CORRESPONDENT 24
April,2007:
A commonly used drug to treat irritable bowel
syndrome has been recalled in US following reports
on serious heart problems. The drug in question,
Zelnorm produced by the Swiss drug giant Novartis,
is a prescription medicine approved in July 2002
for short-term treatment of women with irritable
bowel syndrome (IBS) whose primary symptom is
constipation.
Subsequently Zelnorm got approved in for
treatment of chronic constipation for men and
women under age 65 in August 2004.Currently
Zelnorm is marketed in 55 countries across the
world.
The drug which contains tegaserod as active
agent has been implicated to an increased risk of
serious cardiovascular adverse events associated
with its use by a study. The federal drug watchdog
the Food and Drug Administration (FDA) has
requested that Novartis Pharmaceuticals
Corporation of East Hanover, New Jersey,
voluntarily discontinue marketing. "Here, a
potential risk of very serious harm to patients
who have this non-life-threatening condition was
recently identified, making this action
necessary," said Dr. Douglas Throckmorton, Deputy
Director for the Center for Drug Evaluation and
Research. Novartis has agreed to voluntarily
suspend marketing of the drug in theUnited States.
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.
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.
An estimated 12 million Americans suffer from
the painful and disruptive symptoms of IBS with
constipation. Many have symptoms for five to 10
years, which trigger missed work-days and often
prevent them from participating in everyday
activities with their family and friends.
Novartis markets the therapy under the
trademark Zelnorm (tegaserod maleate) in the US,
Canada, Philippines and South Africa; and as
Zelmac (tegaserod) in Switzerland, Latin America
and the Asia-Pacific region.
BY OUR PHARMA CORRESPONDENT |
