Health Canada has 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. In February, the Society of Obstetricians and Gynecologists of Canada concluded that the risk of venous thromboembolism in Diane-35 users is very low and comparable to that other combined hormonal contraceptives. Blood clot risksĪlso on Friday, a committee at the European Medicines Agency concluded that the benefits of Diane-35 and its generics outweigh the risks when measures are taken to minimize the risk of thromboembolism - formation of blood clots in the veins and arteries. Health Canada announced the review in January, following France's decision to withdraw sales of the medication in response to the deaths of four women over the last 25 years.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 said at the time, noting that the product monograph for the drug contains clear warnings about this potential adverse effect. The regulator said Friday that its review of the safety of Diane-35 concluded its benefits continue to outweigh the risks, when used as authorized. The drug is often prescribed "off-label" as a contraceptive.
Health Canada says its safety review of Diane-35 supports current labelling and use.
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