France Approves The Use Of Acne Medication Diane 35 After Blood Clot Scare
France has become the most recent country to accept the benefits of Bayer acne medication Diane 35 over its possible side effects. This decision comes less than two weeks after the European Medicines Agency (EMA) delivered a proposal to French officials outlining advantages of the drug.
A press release issued by EMA representatives earlier this month stated, "These medicines should be used solely in the treatment of moderate to severe acne... in women of reproductive age. Since Diane-35 and its generics are hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives."
"Based on all available data, the PRAC concluded that Diane-35 and its generics have a place as a treatment option for certain women suffering from the above-mentioned (skin) conditions."
Diane 35 is a prescription acne medication that works by easing hormonal development and has even been known to prevent ovulation. Some doctors have started prescribing it as an oral contraceptive; however, this use is not approved by the EMA, Reuters reported.
Concerns arose after reports of patients developing thromboembolism, blood clot formation in the veins and arteries. In February, Canadian health officials established that the risk of developing blood clots in veins and arteries was minor in Diane 35 compared to other contraceptive medications.
In spite of the EMA's approval, experts still recommend that clearly defined warning labels be developed and that patients fully understand the risks of the medication.