E-DRUG: Cisapride is being withdrawn in Canada
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May 31, 2000
Warning
PREPULSID� to be withdrawn as a result of cardiac complications
OTTAWA - Health Canada is warning consumers who are using the
drug, PREPULSID� (cisapride), of the possibility of rare, but
serious, heart complications, including arrhythmias (irregular
heartbeat rhythms) and sudden death. Consumers using the drug
are advised to contact their physicians as soon as possible to
discuss alternative treatments.
PREPULSID� is used to treat gastro-esophageal reflux
(heartburn), gastroparesis (inability of the stomach to empty
properly), and other disorders of gastrointestinal movement.
PREPULSID� is a prescription drug, marketed by Janssen-Ortho
Inc. Health Canada is requiring that Janssen-Ortho Inc. stop sale of
this product. Effective August 7, 2000, the product will no longer be
available from pharmacies. The manufacturer has also announced
its intention to discontinue marketing of the drug in the United
States.
To date, Health Canada has received at least 44 reports of potential
heart rhythm abnormalities associated with this drug, including 10
deaths in Canada. Most of the patients affected had underlying
medical conditions or were taking drugs known to interact with
PREPULSID�.
In most cases, alternative therapies are available to treat the
gastrointestinal disorders for which PREPULSID� is used.
Availability of PREPULSID� through Health Canada�s Special
Access Programme may be an option for patients who do not
respond to alternative therapies. In accordance with the
requirements of the Special Access Programme, the prescribing
physician has the responsibility for providing an acceptable
rationale for the use of the drug in patients for whom alternative
therapies have failed, are unsuitable, or are unavailable. Health
Canada will then authorize Janssen-Ortho to supply the drug.
Janssen-Ortho has indicated that it will limit the availability of
PREPULSID� to those patients who have little or no alternative to
the drug as a treatment for their debilitating and possibly life-
threatening conditions.
Health Canada will evaluate new safety information as it becomes
available through the Special Access Programme and international
safety reports.
Health Canada has sent a letter to Canadian health care
professionals informing them that PREPULSID� will be withdrawn
from sale. Physicians who would like to obtain further information
on the status of PREPULSID� may contact Health Canada at 1-
800-267-1238.
Health Canada has established a toll-free line for consumers of the
product or the general public interested in this Warning.
Consumers should be directed to 1-800-267-9675.
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