Cisapride and the Vanessa Young inquest

A recent CMAJ editorial is misinformed in its statement that Vanessa Young's death was “undoubtedly caused by the drug cisapride.”1 We acknowledge CMAJ's right to express an opinion about this matter, but readers should be given accurate, factual information, including the following.

On April 24, 2001, a coroner's jury concluded that Vanessa Young's arrhythmia and cardiac arrest resulted “from the effects of bulimia nervosa in conjunction with cisapride toxicity and possibly an unknown cofactor such as congenital cardiac defect.” Significant evidence presented at the inquest from a variety of health care professionals indicated that it was highly probable that Vanessa Young had risk factors for cardiac rhythm problems that could have caused her death independently of any medication she may have been taking.

Distribution of cisapride was stopped in Canada on May 29, 2000, whereas in the United States it was stopped on July 14 and inventory remained in pharmacies until mid- August. Pharmacies stopped selling the drug in Canada on August 2.

Cisapride was clearly contraindicated for people at risk of electrolyte imbalances, including those with bulimia, and this information had been included in the prescribing information for the drug for a number of years before it was prescribed to Vanessa Young. As early as 1995, Janssen-Ortho, Inc., began to send letters to physicians and pharmacists in Canada describing the occurrence of serious cardiac rhythm disturbances in certain patients who had taken the drug and highlighting changes to the prescribing information. This new information was also made available to physicians and pharmacists in the Compendium of Pharmaceuticals and Specialties. Physicians and pharmacists rely on prescribing information approved by Health Canada (which is published and updated in the Compendium of Pharmaceuticals and Specialties annually, among other places), not on patient leaflets, to safely and appropriately prescribe and dispense pharmaceutical products.

Consistent with our commitment to patient safety, we will continue to work closely with Health Canada and medical professionals to examine ways to optimize communication of new clinical findings and prescribing information.