Health Canada’s safety ‘report’ on acne drug Diane-35 says benefit outweighs blood-clot risk

Health Canada has made good on a pledge to release is drug-safety review of the controversial acne medication Diane-35, albeit six months after Health Minister Rona Ambrose promised to do it, the Toronto Star reports.

The drug, which has also been used widely as an "off-label" contraceptive, was implicated in the deaths of 13 young women in Canada, the Star said. But the safety review concludes the benefits of the drug outweigh the risk of developing potentially fatal blood clots.

Media reports last year on Diane-35's problems prompted calls for Ottawa to release its report on the drug but Health Canada initially refused, arguing the report contained "classified business information," the Star said.

Ambrose changed her mind but it's taken until now for the government to follow through, and even then it's a fraction of the information contained in the review. This release, the first in what Ambrose says is a new process to provide transparency, is only a summary of the review.

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"Once a drug is on the Canadian market, Health Canada continues to monitor the safety of health products to identify and assess potential harms," the department said in a news release Tuesday.

"As a result, departmental safety reviews are conducted when a safety issue is identified for a product on the Canadian market.

"The posting of summary safety reviews will provide Canadians with plain-language descriptions of Health Canada's findings and decisions, so patients can make informed decisions and continue to have confidence in the health products they use.

"The full reports will be made available through a link on Health Canada's website; however they are subject to redactions of personal and confidential information."

The Diane-35 safety review summary said the drug and its generic equivalents are to be used only after other acne treatments have not worked, and should be stopped after the acne has cleared. It warns Diane-35 should not be used by those at risk of developing blood clots, which is already spelled out in prescribing information for the drug.

Health Canada concluded the benefits of the drug still outweigh the risks if it's used as intended. It noted that between 35 and 40 per cent or prescriptions for Diane-35 were as a means of birth control, which is considered an unapproved use.

The report also challenged Diane-35's role in the reported deaths connected to the drug since it was introduced in Canada in 1998.

In 10 out of the 12 cases reviewed, the drug was considered the least likely cause of death, with the other two cases not containing enough information to make a determination. In nine of the 10 cases, patients taking the drug had other risk factors for developing blood clots, such as obesity, smoking, previous trauma and decreased mobility, the review said.

"The case reports do not indicate a change in the known safety profile of Diane-35 for blood clots in Canada," it said.

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The Health Canada review was sparked by a decision from France's drug regulator to suspend marketing of the drug following reports of blood-clot deaths.

Ambrose said in her department's release that patient safety was a government priority.

"Greater access to easy to understand (sic) and credible information about the potential risks and appropriate use of health products is one of the most valuable safety tools we can provide Canadians and healthcare professionals," the minister said.