Health Canada brushes off reports of serious side effects

A Bolton teen hanged himself from a tree four days after he started taking Cipralex, an antidepressant. His mother went online and filed a side-effect report to Health Canada.

A pediatrician, troubled by the spate of side effects he was seeing in kids taking a generic version of an ADHD medication, faxed 25 reports to Health Canada over two months.

After a 49-year-old York Region man killed himself while taking smoking-cessation drug Champix, his sister called in a side-effect report to Health Canada.

All three say their reports were ignored.

The Star has found Health Canada is not investigating individual reports of serious side effects.

While the regulator periodically reviews the often-scant information in some reports, the Stars research shows it is not digging deeper to learn about troubling cases. We found no evidence that Health Canada, after receiving these reports, is doing any formal case investigations that would help the regulator better monitor drug safety.

The mothers report went into cyberspace without a response. The sister received an impersonal form-letter thanking her for making the report about her dead brother. The doctor, who expected his faxed reports to alarm Health Canada and send its investigators digging for more information, would be disappointed.

I thought alarm bells would have been going off given that I said somebody died, said Nancy McCartney, whose 18-year-old son Brennan killed himself while on Cipralex. There was absolutely no acknowledgement that anybody has read this, let alone investigated.

A serious report involves patients who either went to hospital, suffered a disability or life-threatening condition, or died.

McCartney wrote in her report to Health Canada: (Brennan) was provided with a sample package (of) Cipralex He did not have a diagnosis of depression. He took one tablet a day on Nov. 5, 6, 7 and 8. He completed suicide on November 8, 2010, and was found 24 hours later. He had no history of mental health issues went to the doctor for a chest cold and came home with an SSRI (antidepressant).

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Health Canada brushes off reports of serious side effects