“Diane-35 is not, and has never been, indicated as an oral contraceptive,” Gadbois-St-Cyr writes in an email. In Canada, it is approved only to treat severe acne in women who are unresponsive to other treatments. “Women don’t go on birth control for six months,” says Rochon Ford. And it’s supposed to be used only for short periods. The biggest problem with Diane-35, according to Rochon Ford, is that it became widely used for contraception though it was created and tested to treat severe acne. But in a study of about 100 000 women in the United Kingdom, it was found to be four times as likely to occur in those taking the progestin used in Diane-35, cyproterone, compared to the alternative levonorgestrel ( Contraception 2002 65:187–96). Those women, eight of whom were under age 30, experienced various complications prior to their deaths, including blood clots in their legs, chest pain, bleeding in their brains or blockages in their lungs.Ĭases of venous thromboembolism in women taking combination oral contraceptives date back to the 1960s. The standard timeline for such a review is 60 days, notes Gadbois-St-Cyr, though this one will be conducted in an “expedited manner” and Health Canada will “take appropriate action as necessary once the review is complete.” Since 2000, the deaths of 11 Canadians aged 15–46 have been linked to the drug, according to 200 Health Canada adverse reaction reports recently obtained by the Toronto Star. “When a foreign regulator takes action on a drug, it prompts a new review of the drug by Health Canada to account for any new information that may be available and to review information in the Canadian context with respect to drug indication and use in Canada,” Judith Gadbois-St-Cyr, a media relations officer with Health Canada, writes in an email. Health Canada is also re-examining the drug. Now other countries are reassessing its safety and the European Medicines Agency has initiated a Europe-wide review. ![]() More recently, France issued a three-month advertising ban for Diane-35 and its generic equivalents after reviewing 25 years of data and linking four deaths to the drug. Of course, this has been known for many years. One of its adverse effects is thromboembolism, such as deep venous thrombosis, pulmonary embolism, stroke or myocardial infarction. That product - cyproterone acetate and ethinyl estradiol, commonly known as Diane-35 - is under intense scrutiny in many countries, including Australia and Canada. ![]() “It’s not as popular as in the 1990s,” says Rochon Ford. They are the ones, she figures, who are using it. In 2003, a CBC News investigation revealed that thousands of Canadian women were taking the drug solely for birth control, unaware of the potential risks.When Anne Rochon Ford mentions the potential dangers of a drug sometimes used for birth control to groups of women, she scans the room and watches the faces drop. The department has issued previous warnings about the increased risk of blood clots associated with Diane-35 compared with estrogen/progestogen contraceptives, and has cautioned against using the acne drug for birth control.Ĭonsumers experiencing symptoms of a possible blood clot - including persistent leg swelling, leg pain or tenderness, chest pain, or sudden shortness of breath or difficulty breathing - should seek immediate medical attention.ĭoctors should be told about any medications being taken, including Diane-35, Health Canada said. Health Canada said Diane-35 should not be used in patients with a medical history that puts them at risk for blood clots, including smoking, being overweight or a family history of the condition. However, the drug is often prescribed "off-label" as a contraceptive.īlood clots are a rare but well-known side-effect of oral birth control pills and other hormonal products such as Diane-35, said the federal department, noting that the product monograph for the drug contains clear warnings about this potential adverse effect. Meanwhile, doctors are banned from prescribing the medication.Īvailable since 1998 in Canada, Diane-35 is approved only for the temporary treatment of severe acne in women who are unresponsive to other treatments, Health Canada said Thursday. It has been sold in France since 1987.įrance's National Agency for the Safety of Drugs and Health Products said this week that Diane-35, made by Bayer and licensed in 135 countries, would be withdrawn from sale in three months. The women died of blood clots linked to their use of Diane-35, an acne drug that is also widely prescribed as an oral contraceptive because it halts ovulation. Health Canada says it is reviewing all available safety information on the drug Diane-35 following France's decision to ban the medication in response to the deaths of four women over the last 25 years.
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