Health Canada is currently conducting a review of all available safety information on the drug Diane-35. Health Canada has been monitoring the safety of Diane-35 on an ongoing basis, as it does for all drugs on the market. The Department is aware of the decision by France to suspend the marketing authorization of Diane-35 within the next three months. In Canada, Diane-35 is approved for the temporary treatment of severe acne in women who are unresponsive to other available treatments.
Blood clots are a rare but well-known side-effect associated with oral birth control pills and other hormonal products such as Diane-35. The current Canadian Product Monograph, including the patient information section, contains clear warnings regarding this issue. Health professionals are reminded that Diane-35 should not be used in patients with a history that puts them at risk for blood clots. Known factors that increase the risk of blood clots include smoking, being overweight (obesity), and a family history of blood clots.
Health Canada has previously communicated with Canadians regarding this product. On December 19, 2002, April 10, 2003 and May 12, 2005, Health Canada issued communications advising of the increased risk of blood clots in users of Diane-35 compared to estrogen/progestogene combinations used for contraception. Health Canada also cautioned against using Diane-35 as an oral contraceptive.
Patients who think they are experiencing symptoms of a blood clot should seek immediate medical attention and mention any medications they may be taking, including Diane-35. Symptoms of a blood clot may include persistent leg swelling, leg pain or tenderness, chest pain, or sudden shortness of breath or difficulty breathing.
Health Canada will take appropriate action as necessary once the review is complete.