Health Canada released Friday a review of Diane-35, a drug used to treat acne and also prescribed as birth control. The agency found out that the benefits of using the drug as temporary treatment for acne outweighs the risks when used as prescribed.
The drug is approved in Canada as treatment for severe acne in women who do not respond to other available medicines. This case of severe acne often involves oily skin, excessive hair on the body, and a high level of male hormones.
Health Canada announced that it will perform the review back in January after France decided to withdraw sales of Diane-35 following four deaths over the last two decades. The regulatory body explained that blood clots are known side effects of birth control drugs and hormonal products but occur rarely. It also took note that the drug literature warns of the possible adverse effects of these medicines.
The same conclusion was also reached on Friday by the European Medicines Agency. It declared that Diane-35 and any of its generics has more benefits compared to the risks when precautions are taken to lower the risk of blood clot formations in arteries and veins.
The Society of Obstetricians and Gynecologists in Canada conducted a study last February and concluded that the risk of thromboembolism with the use of Diane-35 is quite low. The organization reiterated that the findings are just comparable to other hormonal contraceptives taken by women.
Health Canada advises the public not to take Diane-35 if the patient has a medical history that will up the risks of blood clot formation. These cases include being overweight, smoking or other relevant conditions within one's family.
The regulator also warned the public before about the use of Diane-35 as a birth control drug comparing it to the blood clot formation risks when using other contraceptive drugs.
Individuals who might be experiencing symptoms of blood clotting should seek medical advice immediately. Patients are reminded to tell their doctors about any medication that they are taking, including Diane-35. Some symptoms of blood clotting include leg pain, leg swelling, difficulty breathing or chest pain.
Back in 2003, a report came out about thousands of women in Canada taking Diane-35 as a birth control drug without knowing the risks that comes with it.
