Prepulsid jury wants drug-warning reforms
Last Updated: Wednesday, April 25, 2001 | 10:50 AM ET
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It is estimated that every year about 10,000 Canadians die from the side effects of prescription drugs.
Vanessa Young was one of those victims. Last year, the 15-year-old Oakville teenager died suddenly after taking a stomach pill called Prepulsid. She was on the medication to treat an eating disorder.
Prepulsid was not supposed to be given to people with eating disorders because it can cause severe, and sometimes fatal, heart disturbances.
The jury wants the major players responsible for drug safety in Canada to spend the next year working together to study reforms. In particular, the jury says that Health Canada, provincial health ministries, drug companies, doctors and pharmacists must all do a better job of getting safety information to consumers.
That information, says the jury, should be given to patients more quickly, and in language they can understand.
"We do know that Prepulsid is safe and effective when it is used according to its approved labelling," said Wendy Arnott who speaks for Janssen-Ortho, the company that distributed Prepulsid.
She was asked to comment on the recommendations that called on companies like hers to issue clearer and swifter safety warnings. She refused to answer the question directly.
For its part, Health Canada was asked to comment on what Vanessa Young's family considers another key recommendation: that physicians and pharmacists be forced to tell Health Canada when drugs are harming or killing people.
Andre Chamberland is the government lawyer who represented Health Canada during the inquest. He says mandatory reporting is a great idea. "The problem is that Health Canada does not have the jurisdiction to tell doctors to report adverse drug reactions. That is something the provincial bodies have to do," he said.
The inquest heard a lot of evidence that pointed to major weakness in the drug approval and monitoring system. For instance, three weeks before Vanessa Young died, Health Canada and the drug company failed to ensure that an important safety warning received any publicity.
And there were questions about how quickly Health Canada acted to demand that the company pull the drug from the market, which eventually happened last summer.
As far as Gary Will is concerned, these are still questions that demand answers. That's why the lawyer for the Young family wants a general inquiry into the country's drug approval process. "It's not just Vanessa Young. There were hundreds of people that were affected in Canada. Thousands worldwide. And this wasn't the only drug. There are lots of drugs that are causing people to die."
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