Ottawa Citizen

Canada's top medical journal to print more timely drug advisories from faster-acting U.S. agency: 'We can't rely on Health Canada': editor

Richard Starnes, with files from Bev Wake The Ottawa Citizen

The nation's leading medical journal says Health Canada is so slow at warning the public about possible dangers from prescription drugs that it is turning to the Americans for information.

"We are now going to report on our pages all Federal Drug Administration warnings on any drug also sold in Canada, because we can't rely on Health Canada to do it," said Dr. John Hoey, editor of the Canadian Medical Association Journal.

Dr. Hoey said Health Canada does publish an adverse drug reaction newsletter four times a year and distributes it through the CMAJ. But he added that the FDA is almost always first with warnings, a fact that in some cases could be a matter of life and death.

The decision is to be published today in the latest issue of the journal, which reaches more than 80 per cent of the country's physicians.

The move was prompted by the death of a 15-year-old Oakville girl who had been taking a prescribed heartburn medication called Prepulsid, also known as Cisapride.

Vanessa Young had been taking the drug to treat heartburn and digestive problems for three months before her death.

She died on March 20, 2000 -- 55 days after the FDA had issued a warning about the drug in the United States, but 73 days before Health Canada issued the same alert.

The FDA took the drug off the market on July 14, but it remained available in Canada until it was pulled on Aug. 7.

"Our question is simple," said Dr. Hoey. "Why the delay?"

Vanessa's father, Terence Young, said last night Health Canada did not serve Canadians well by "dragging its feet" with regards to warning people about Prepulsid.

"With regards to this drug, certainly Canadians would have been much safer if Health Canada didn't exist and there was a small office of two or three people duplicating what the FDA did," he said.

The CMAJ points out in an editorial that Ms. Young's pharmacist testified at her inquest that he was unaware of any particular risk from the drug. He also testified that the information sheet handed out with the drug made no mention of the ventricular arrythmia that, since 1990, had resulted in 80 deaths in Canada and the United States.

The CMAJ suggests that three people need information about drug risks: the patient, the pharmacist and the physician. Pharmacists rely on information provided by manufacturers or packaged by private companies -- information that is sometimes incomplete.

"Who should take responsibility for patient information leaflets?" the editorial asks. "The one available to Vanessa (Young) was falsely reassuring; if she had obtained the drug in the U.S., the information would have told a different story."

In the U.S., information leaflets have to be FDA-approved before being distributed with the drug. This is not the case in Canada.

Health Canada officials would not comment on the CMAJ's decision yesterday.

"We're not going to comment on this article because we have not seen it," spokesman Ryan Baker said. "It's the most responsible thing to do."

The CMAJ says this is not the first time it has watched Health Canada lag dangerously behind the Americans -- "but it is the last time we will merely observe."

From now on, the journal will monitor every FDA advisory on serious drug reactions, take any that is relevant to the Canadian market and publish that warning.

"The information will appear on our Web site immediately and in the next available issue of the magazine," says Dr. Hoey.

The jury probing Vanessa's death at the Hamilton inquest, which ended April 24, said the teen might not have died had she had proper warnings about Prepulsid. The jury made 50 recommendations that would make it easier for people to get drug warnings and would alter the way drugs are labelled and administered.

The jury also recommended that it be mandatory for doctors and pharmacists to report a patient's adverse reactions to a drug to Health Canada within 48 hours. That procedure is now voluntary.

-- Rachel Gibson (rgibson@hotmail.com), May 01, 2001