The Agency has announced that Diane 35 and its generics are subject to a “specific analysis“Diane 35 is a drug to fight against acne, marketed since 1987. Its composition with synthetic hormones (estrogen and a derivative of progesterone) has a contraceptive effect for women.
“Diane 35 is an acne treatment that induces ovulation blockage. We have several investigations in progress which show that this off-label use is important“, explained the director of the ANSM, Dominique Maraninchi, during an update on the risks of the 3rd and 4th generation pills, deeming” abnormal “the misuse of this anti-acne treatment. The National Security Agency drug and health products (ANSM) reveals four deaths over the past 25 years “due to venous thrombosis linked to Diane 35“, a treatment from Bayer laboratories against acne but for misuse as an oral contraceptive.
The agency said on Sunday that it would return “its conclusions on the benefit / risk analysis of Diane 35 and its generics next week“and take” the appropriate measures “.
The Bayer laboratory commented on this information by recalling that the risk of a clot forming in the blood, linked to taking its acne medication Diane 35, was “known and clearly indicated in the patient information leaflet”, and that Diane 35 should only be prescribed against acne and not as a contraceptive.
The Diane 35 finds itself at the forefront of the medical scene in an unfavorable context. Indeed, 3rd and 4th generation contraceptive pills, widely prescribed in France, are the subject of criticism and lawsuits because of the increased risk of thrombosis they present compared to 2nd generation pills.
