Health Canada's new drug safety summary launches

Health Canada's first safety summary for a medication is now published online on what's they've called a transparency site.

Federal Health Minister Rona Ambrose announced the regulatory transparency and openness program on Tuesday in Ottawa.

The site went live with one safety review for Diane-35, a drug that hasbeenapproved for treating acne, but has been used without approval, or off-label,for birth control.

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Diane-35 has been linked to deadly blood clots. Blood clots are a rare but well-known side-effect of oral birth control pills and other hormonal products such as Diane-35.

"As part of Health Canadas Regulatory Transparency and Openness Framework, the department has committed to providing Canadians with credible and timely information," Health Canada's web site said. "This easy to understand information will allow them to make well-informed decisions concerning their health and that of their families."

Diane-35 is the only drug featured on the site so far, but as more drugs undergo safety reviews, they can be included. Prior reviews will not be included retroactively.

The transparency site depicts an open door. Health Canada said the posting of summary safety reviews is the first in a series of steps towards transparency and openness.

Full technical reviews, which Ambrose said can total up to 1,000 pages, will be available by clicking to submit an email request. Those reports could exclude personal and confidential information.

The site includes achecklistfor physicians and patientswhich Ambrose called an "important, practical tool" to prescribe Diane-35 appropriately.

Dr. David Juurlink, a staff internist and head of clinical pharmacology and toxicology at Toronto's Sunnybrook Health Sciences Centre, said reducing off-label prescribing is more likely to happen with negative press, such as reports of deaths and other serious adverse events.

"I think that Health Canada has for decades been a black box," Juurlink said.

"It's good that the regulator is putting these decisions out. I just think that they're doing it awfully slowly and it's difficult to justify not doing it retroactively. There's a whole group of drugs out there that they have made assessments of, and the idea that they shouldn't cast some light on those decisions is ludicrous. They are depriving doctors and patients of important information when they decide to keep this information under wraps for no good reason."

In 2003, a CBC News investigation revealed that thousands of Canadian women were taking Diane-35 solely for birth control, unaware of the potential risks.