[e-drug] Popular heartburn drug to be withdrawn in the U.S.

[AHMADS@cder.fda.gov]

E-drug: Popular heartburn drug to be withdrawn in the U.S.
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Dear E-druggers,

A popular heartburn drug cisapride is being withdrawn in the U.S. I
would be interested to know the status of this drug in other countries
especially if there is any similar announcement about the withdrawal.

Thanks,

Rizwan

Syed Rizwanuddin Ahmad,MD, MPH
Medical Epidemiologist
Division of Drug Risk Evaluation 
Office of Postmarketing Drug Risk Assessment
Center for Drug Evaluation and Research
Food and Drug Administration
HFD-430, Rm 15B-08
5600 Fishers Lane
Rockville, MD 20857, USA
Email: ahmads@cder.fda.gov


FDA Talk Paper

March 23, 2000                       

JANSSEN PHARMACEUTICA STOPS MARKETING CISAPRIDE IN THE US

Janssen Pharmaceutica Inc., of Titusville, N.J., USA, has announced that
it has decided to stop marketing cisapride (Propulsid) in the United States
as of July 14, 2000. The effective date of the voluntary action is
intended to provide adequate time for patients and physicians to make
alternative treatment decisions.

Cisapride is a prescription drug treatment approved only for severe
nighttime heartburn experienced by adult patients with gastroesophageal
reflux disease (GERD) that does not adequately respond to other
therapies.

As of December 31, 1999, use of cisapride has been associated with 341
reports of heart rhythm abnormalities including 80 reports of deaths.
Most of these adverse events occurred in patients who were taking other
medications or suffering from underlying conditions known to increase
risk of cardiac arrhythmia associated with cisapride.

Patients who are currently prescribed cisapride are urged to promptly
contact their health care providers to discuss alternative treatments.

Physicians who are treating patients with severely debilitating
conditions for whom they believe the benefits of the cisapride may still
outweigh its risks are encouraged to contact Janssen at 1-800-JANSSEN.
The company will continue to make the drug available to patients who
meet specific clinical eligibility criteria for a limited-access
protocol.

Since the drug's approval in 1993, Cisapride's labeling has been revised
several times (most recently in January 2000, see FDA Talk Paper T00-6
www.fda.gov) to inform health care professionals and patients about the
drug's risks. Despite these risk management efforts, the firm decided in
consultation with the Food and Drug Administration that continued
general US prescription access to the drug poses unacceptable risks.

A public advisory committee meeting, previously scheduled for April 12
to discuss ways to reduce the occurrence of adverse events associated
with cisapride, has been cancelled.

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