The controversial acne medication Diane-35 was a “possible” cause of 10 deaths in Canada since 1998, according to a summary of a safety review released as part of Ottawa’s efforts to be less secretive about how pharmaceuticals are monitored in this country.
The four-page synopsis of Health Canada’s 2013 safety review of Diane-35 and its generic equivalents was the first of safety reviews to be made public on a new website unveiled Tuesday by Health Minister Rona Ambrose.
“With this initiative, Canada is now a world-leader in the posting of drug-safety reviews and post-market access to this information, ahead of the U.S. and the [European Union,]” she said.
Drug-safety experts called the new website a step in the right direction, but they warned it does not go far enough to fulfill Ottawa’s promise of a more transparent federal drug regulator.
“They’re cracking open the blinds a little bit,” said David Juurlink, a physician and drug-safety researcher at Sunnybrook Health Sciences Centre in Toronto. “It would be nice if they would just open the window.”
Health Canada is not planning at this point, for example, to post any of the other drug safety reviews completed by the department last year, nor will it publish periodic safety updates or risk management reports prepared by drug makers.
Instead, Health Canada will post only brief, plain-language, synopses of future drug safety reviews – reviews which can be triggered by anything from reports of adverse reactions to a medication to fresh scientific evidence to red flags raised in another country, as happened in the case of Diane-35.
Future complete reviews, which can be hundreds of pages long, will now be available by request.
“It’s better than nothing. Having said that, that’s about what Health Canada has done up to this point – nothing,” said Joel Lexchin, a professor in the school of Health Policy and Management at York University and an emergency room doctor at Toronto’s University Health Network.
Ms. Ambrose said she would be open to releasing summaries of some past safety reviews if the public demands it.
“[If] there is overwhelming interest to have a drug safety review looked at, or a summary developed, we can do that,” Ms. Ambrose said. “But to commit to go back and redo thousands of them I think would be a little overwhelming for the department.”
Ms. Ambrose said releasing the Diane-35 safety review was a priority because “the message has not been getting out” that the drug should be used only on a short-term basis and as a last-ditch treatment for severe acne, not as a long-term method of birth control.
France announced on Jan. 30, 2013 that it was suspending sales of Diane-35 while its regulator investigated reports of serious blood clots linked to the hormonal drug, which is frequently used off-label as a contraceptive because it halts ovulation.
Health Canada launched its own probe shortly afterward. In May of last year it released its conclusion that Diane-35’s “benefits continue to outweigh the risks, when used as authorized,” but Health Canada kept the review itself secret.
The synopsis of that review released Tuesday showed that between 1998, when Diane-35 became available in Canada, and May 1, 2013, there were 95 adverse reactions to the medication, including 12 deaths, voluntarily reported to a Health Canada database.
About 40,000 women in Canada use Diane-35 every year, and 35 to 40 per cent of those take the drug off-label as birth control.
After investigating the dozen deaths, Health Canada concluded that in 10 of the cases, “the likelihood of the drug causing the death was considered to be at least possible.”
In nine of those instances, the patients had additional risk factors that would predispose them to blood clots, such as “obesity, smoking, previous trauma and decreased mobility.”
In the final two cases, there was not enough information to draw a conclusion, the summary said.
Bayer, the drug company that makes Diane-35, pointed out that the safety review does not say the medication directly caused any of the deaths.
“Blood clots are a rare but well-known side effect associated with the use of hormonal products containing progestins and estrogens, such as Diane-35. These risks are clearly referenced in the Product Monograph. In more than 20 years and millions of women using the product, fatalities related to Diane-35 have been extremely rare,” the company said in a statement.
Bruce McKenzie figures his daughter, Marit, was one of the two patients for which Health Canada did not have enough information to make a finding.
The petite 18-year-old University of Calgary student did not have any other risk factors for blood clots when she began taking Diane-35 for minor acne 11 months before her death on Jan. 28, 2013 – just two days before France temporarily suspended sales of the drug. (Diane-35 was reinstated in France in January of this year.)
Mr. McKenzie and his family have been fighting to see Health Canada’s safety review for months, part of their campaign to warn other women of the potential dangers of a drug they believe led to the death of their “angel,” a loss that has devastated the family, particularly her mother.
“It’s about bloody time. I’ve been chasing [Health Canada] for six months trying to get information out of them and they don’t return my e-mails or my phone calls. It’s disgusting,” Mr. McKenzie said in an interview.
However, he said he was pleased the summary safety review has now been made public.
“This was a very special young lady,” he said, his voice cracking. “When you ask how are we doing, I think we’re doing pretty good. But it’ll never be the same.”Report Typo/Error
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