Health Canada says it will conduct a review of all available safety information about a controversial acne medication that is often prescribed to young women as birth control.
The move comes after France temporarily banned the prescription of Diane-35 and following media reports that the drug may have played a role in the deaths of 11 young women in Canada.
But Health Canada said in a statement late Thursday that it will not take any action until the review is complete.
Diane-35 has a long, tortuous history but nevertheless remains a popular product, especially with teenage girls concerned about acne.
The drug is supposed to be prescribed only as a treatment of last resort for young women with severe acne. But it is often prescribed off-label as an oral contraceptive.
Diane-35 is even packaged like birth-control pills, in a 28-pill holder and taken to coincide with a woman’s menstrual cycle, ostensibly because in young women acne breakouts are often related to menstrual cycles.
Most birth-control pills help clear up acne because they stabilize hormone levels.
One of the ingredients in Diane-35, cyproterone acetate, is seen as particularly potent. However, it is more likely to cause blood clots, which is why the drug should not be used as an oral contraceptive.
Earlier this week, the Toronto Star reported that there were 195 reports of severe adverse effects among users of Diane-35. That number included 11 women who died, among them four teenagers.
Diane-35 was introduced into Canada in the 1990s with a flashy billboard advertising campaign in which it was touted as “The Acne Solution.” The manufacturer, Berlex Canada, clashed with regulators about the legality of those ads. (Berlex was taken over by Bayer Inc., which sells the drug in Canada.)
Over the years, Health Canada has issued repeated warnings about Diane-35.
Bayer said in a statement Thursday that the product is safe when used properly and it was “not aware of any new scientific evidence leading to a change in the positive benefit-risk assessment of Diane-35.”
Europe’s drug regulator, the European Medicines Agency (EMA), issued a statement late on Wednesday saying France had indicated its intention to ask for a European-led safety review of the medicine, but had not yet done so.
It said once France made a formal request, its risk-assessment committee would “evaluate all evidence on the benefits and risks of these medicines and give a recommendation on whether their marketing authorizations should be varied, suspended or revoked.”
With a report from Reuters