Diane-35: Reconsidering the risks

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Publication Date: 
Thu, 2013-08-01

By Holly Grigg-Spall

A young woman admires her flawless skin in her bathroom mirror; smiling to herself she is pleased with what she sees in the reflection. Then, she climbs through the mirror and into a better life, one filled with friends, dancing, fashion, fitness regimes, transparent umbrellas—she’s got nothing to hide—and a good-looking, happy boyfriend. As the young woman jumps back into her bathroom seemingly thrilled with the lifestyle her clear skin has provided, a brightly colored packet of pills that closely resemble oral contraceptives appears in the foreground. “Diane 35: Ask your doctor or dermatologist” is the accompanying message.

Diane-35 is comprised of synthetic anti-androgen cyproterone acetate and synthetic estrogen ethinyl estradiol, making it as effective at preventing pregnancy as all birth control pills, although it has never been approved as a contraceptive. Since its release in Canada in 1998, Diane-35 has only been approved by Health Canada for cases of severe acne with a stipulation that women take the drug for just a few months and only if other possible treatments have been tried and failed.

‘Was a problem waiting to happen’

Prior to the widespread distribution of the commercial campaign described above, Health Canada had issued two warnings informing women and their doctors that Diane-35 held a risk of causing blood clots four times higher than the risk associated with other birth control pills. A number of women’s groups collaborated to register a complaint with Health Canada about the nature of the advertisements that were shown in movie theatres, on television, on billboards and in public washrooms. This was in the same year that CBC aired its investigation of the potential dangers, A Hard Pill To Swallow.


Since its release in Canada in 1998, Diane-35 has only been approved by Health Canada for cases of severe acne with a stipulation that women take the drug for just a few months and only if other possible treatments have been tried and failed. See the Globe & Mail article April 8, 2014 about the recent review of Diane-35.

“The CBC documentary showed that the pharmaceutical company actively pursued prescription of this drug as a form of birth control, and so for extended use by women,” says Dr. Barbara Mintzes, a drug policy researcher and assistant professor at the University of British Columbia. “Diane-35 is an example of regulatory failure. This was a problem waiting to happen.” 

Mintzes was among those associated with the women’s health groups, including Women and Health Protection in Canada, that protested the marketing campaign used to promote Diane-35. “There isn’t good evidence that this is something anyone needs. Evidence suggests all birth control pills have some effect against acne and there isn’t a clear advantage to this one,” she says. “This drug has never actually been tested within the population it is approved for—those suffering severe acne. Diane-35 was one of the first medications to be marketed to the public in Canada aggressively and illegally.”

Off-label prescription of the drug by doctors for birth control combined with the marketing strategy by Berlex, now Bayer, saw 800,000 women prescribed Diane-35 in 2002, the majority of whom were using it for birth control and so taking the drug for long periods of time despite the warnings from Health Canada. Although the CBC documentary may be credited with lowering the number of users for a short time, prescriptions for Diane-35 continued to grow from 2003 onwards for women in their teens through menopause.

Health Canada review

In February 2013, Health Canada undertook a review of the drug, prompted by the decision by the regulatory body in France, ANSM, to stop sales of Diane-35. ANSM made this decision while conducting its own review into four reported deaths of young women in France that were linked to Diane-35. Health Canada, faced with 11 reported deaths of otherwise healthy women related to Diane-35 since its release in Canada in 1998, had little choice but to reconsider the risks. Three months later, with little discussion of the process that occurred in the interim, Health Canada announced its conclusion that the benefits of Diane-35 outweigh the risks within the boundaries of its approved use. The European Medicines Agency—the Europe-wide regulatory body—echoed this statement, but the ANSM in France (at the time of writing this article) has maintained the suspension of Diane-35 prescriptions, although the decision is under review.

For some, Health Canada’s decision is questionable considering that the widespread off-label prescribing of Diane-35 as a contraceptive and the flouting of recommended restrictions is what brought the agency to this point of review. 

The benefit of this drug, according to Health Canada’s description, is the alleviation of a non-life-threatening but quality-of-life threatening issue: severe acne. The risk of this drug is a life-threatening blood clot (venous thromboembolism).  Health Canada, nonetheless chose to allow continued use, as stated in this warning from the agency: 

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