# \[e-drug\] Cisapride is being withdrawn in Canada **URL:** \ **Category:** e-drug\ **Created:** [June 5, 2000, 10:43am UTC](https://talk.edrugplus.org/t/e-drug-cisapride-is-being-withdrawn-in-canada/8326 "2000-06-05T10:43:53Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![e-drug2](https://avatars.discourse-cdn.com/v4/letter/e/8dc957/32.png) [@e-drug2](https://talk.edrugplus.org/u/e-drug2)\ **Post date:** [June 5, 2000, 10:43am UTC](https://talk.edrugplus.org/t/e-drug-cisapride-is-being-withdrawn-in-canada/8326/1 "2000-06-05T10:43:53Z")
E-DRUG: Cisapride is being withdrawn in Canada ----------------------------------------------------------------------- May 31, 2000 Warning PREPULSID� to be withdrawn as a result of cardiac complications OTTAWA - Health Canada is warning consumers who are using the drug, PREPULSID� (cisapride), of the possibility of rare,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. -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.