Cisapride did not play “significant” role in Ontario deaths, coroner says

A coroner's investigation has determined there is “no conclusive evidence” that the antireflux drug cisapride played a significant role in the deaths of 7 patients at an Ontario hospital, but the pharmacist who reported the deaths to Health Canada remains unsatisfied.

Sana Sukkari, who works at Joseph Brant Memorial Hospital in Burlington, Ont., says she never expected conclusive evidence to emerge from the investigation, but she did expect it to recognize that the drug cisapride (Prepulsid) had been contraindicated for the patients and may have shortened their lives.

Although the results of coroner investigations are not released, families of the patients involved do receive a copy.

Dr. Ben Carruthers, the chief of staff at Joseph Brant, said the investigation hasn't resulted in any policy changes at the hospital. Existing safety mechanisms include having a pharmacist available for all patient care units, and computer programs that flag drug–drug interactions. Carruthers said cisapride use was standard practice at the time of the deaths.

Cisapride was also at the centre of a coroner's inquest into the death of Vanessa Young, 15, of Oakville, Ont., in March 2000 (CMAJ 2001;165[1]:1370). The drug, which was withdrawn from the market in August 2000, had been contraindicated for bulimic patients like Young, and for patients with heart disorders. The drug was linked to 80 deaths in Canada and the US.

According to the reports Sukkari filed with Health Canada, the 7 patients at Joseph Brant ranged in age from 54 to 84. Some were taking cisapride and cardiac medications that had been identified as having potentially dangerous interactions. All of the patients were extremely ill and receiving treatment in the hospital's intensive care unit. Sukkari remains convinced that the use of cisapride was “at least contributory in the outcomes of these 7 patients.”

Terrence Young, Vanessa Young's father and an outspoken advocate for reform of Canada's drug-approval system, supports that view. “The bottom line is that the drug was given when it shouldn't have been,” he said. — Barbara Sibbald, CMAJ