OTTAWA - Health Canada has completed a safety review of the anti-acne medication Diane-35 and determined the drug’s benefits outweigh its risks when appropriately used.
In Canada, Diane-35 is approved for the temporary treatment of severe acne in women who are unresponsive to other treatments.
The federal agency says it should not be used in patients with a history that puts them at risk for blood clots nor as an oral contraceptive.
Diane-35 has been widely prescribed "off label" as an oral contraceptive because it halts ovulation.
Health Canada began its safety review in February after France banned Diane-35 following the deaths of four women over 25 years from blood clots linked to the drug.
Blood clots are a rare side-effect of hormonal products such as Diane-35, and smoking, being overweight or having a family history of blood clots increases the risk.
The European Medicines Agency has also been evaluating the safety of Diane-35, which is made by Bayer and licensed in 135 countries. On Friday, an EMA committee studying the drug's safety proposed an update to its authorized use in Europe similar to that in Canada.
Patients who believe they have symptoms of a blood clot should seek immediate medical attention and mention any medications they may be taking, including Diane-35, Health Canada said. Those symptoms may include persistent leg swelling, leg pain or tenderness, chest pain, or sudden shortness of breath or difficulty breathing.
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