Archived - PREPULSID (cisapride)

Starting date:

May 30, 2000

Posting date:

May 30, 2000

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-1700095

• Affected products

Notice about Health Canada advisories

Therapeutic Products Programme
Holland Cross, Tower "B"
2nd Floor, 1600 Scott Street
Address Locator # 3102D1
OTTAWA, Ontario
K1A 1B6

May 30, 2000

00-020527

Dear Health Care Professional:

Re: PREPULSID (cisapride)

Health Canada would like to advise you that the prokinetic drug, PREPULSID (cisapride), will no longer be available from pharmacies effective August 7, 2000. PREPULSID, marketed by Janssen-Ortho Inc., is a prescription drug indicated for the treatment of gastroparesis, intestinal pseudo-obstruction, and gastroesophageal reflux disease which is refractory to lifestyle modifications, antacids, and gastric acid reducing agents. The decision to withdraw PREPULSID from the market is founded on the association of the drug with serious cardiac arrhythmias (e.g. ventricular tachycardia, torsades de pointes, and ventricular fibrillation) and sudden cardiac deaths. Between its introduction in 1990 and February 2000, Health Canada received at least 44 spontaneous domestic reports of potential cardiac rhythm abnormalities^{Footnote 1} associated with PREPULSID, including at least 10 reports of death. In the United States, the Food and Drug Administration has received 341 reports of cardiac rhythm abnormalities, including 80 fatalities. The continuing occurrence of such adverse events, despite several letters to health care professionals and changes to the Product Monograph, has led to the conclusion that the risks associated with PREPULSID are not manageable in the setting of licensed drug use.

Health Canada advises physicians who currently have patients on PREPULSID (cisapride) to contact these patients as soon as possible and establish whether their conditions can be treated with other therapies (e.g. lifestyle modifications, acid suppression, surgery, etc.). Pharmacists dispensing PREPULSID should advise patients to immediately contact their prescribing physicians to develop an appropriate treatment plan.

Patients with severe gastrointestinal motility disorders, who are refractory to alternative therapeutic modalities, may be eligible for access to the drug through Health Canada's Special Access Programme. In accordance with the requirements of the Special Access Program the prescribing physician has the responsibility to determine if the benefits of treatment outweigh the risk of serious cardiac adverse events. Janssen-Ortho Inc. has indicated to Health Canada that it will limit the availability of PREPULSID to those patients who have little or no alternative to PREPULSID as a treatment for their debilitating and possibly life-threatening conditions. The Special Access Programme is prepared to authorize Janssen- Ortho to release PREPULSID for these patients. Health Canada has been advised that Janssen-Ortho will be announcing further details in the near future.

The Special Access Programme authorization does not constitute an opinion or assurance that a drug is safe, efficacious, or of high quality. The Special Access Programme strongly encourages practitioners treating individuals with drugs obtained through the programme to seek informed consent before initiating treatment. The physician must report adverse events associated with the use of PREPULSID to Health Canada and Janssen-Ortho Inc.

Questions concerning the withdrawal of PREPULSID may be directed to a special Health Canada information centre which has been established to deal with this issue (1-800-267- 1238).

A copy of the February 2000 letter to health care professionals is attached for your information and can also be accessed at the Janssen-Ortho web site at www.janssenortho. com. Further medical information relating to PREPULSID may be obtained from Janssen-Ortho Inc. at 1-877- 506-2752.

Yours sincerely,

Original signed by

Robert G. Peterson, M.D. PhD. MPH
Associate Director General

Affected products