This medication is prescribed in more than half of cases as a contraceptive while the marketing indication is as anti-acne.
On the agenda the technical committee of the 31 pharmacovigilance centers which meets today at the initiative of the National Medicines Agency (Ansm), oral contraceptives. And more particularly, the fate that should be reserved for Diane 35. This drug, which obtained its Amm, like anti-acne, is prescribed in the majority of the cases (60%) like contraceptive. The Ansm reports four deaths attributable to venous thrombosis linked to Diane® 35 since 1987. Prescriptions diverted, contraindications not respected, will this drug be withdrawn from the market, suspended or be the subject of reinforced controls from the health authorities. The director of the Ansm says that we must “stop” using Diane 35 as a contraceptive. While waiting for the conclusions of the experts, a few reminders.
Indications
Diane 35 was marketed in France in July 1987 as part of the treatment of acne. Its effectiveness is considered moderate by the National Medicines Safety Agency. This drug is authorized in 135 countries and marketed in 116. In the majority of cases, it has received an indication for prescription for acne, but sometimes oral contraception is associated.
Uses
About 315,000 women, according to the Ansm, are treated in France by Diane 35. In 60% of cases (189,000 women), it is used as a contraceptive, that is to say outside of the Marketing Authorization indications.
Who prescribes Diane 35?
The drug is prescribed mostly by general practitioners (60%), then by gynecologists (37%) and finally by dermatologists (3%). According to Ansm data reported by Le Monde, gynecologists prescribe it as an anti-acne in only 7% of cases.
Contraindications
The history of arterial or venous thrombosis, as well as the presence of cardiovascular risk factors, is given in the package leaflet and in the Summary of Product Characteristics.
The risks
Diane 35 increases the risk of venous thrombosis in the first year by 6.68 compared to women not taking oral contraception.
Pharmacovigilance data
In a press release issued last weekend on the basis of pharmacovigilance declarations, Ansm reports four deaths attributable to venous thrombosis linked to Diane® 35 since 1987 “For three other cases, the cause of death is linked to underlying pathologies of the patients concerned ”.
In addition, 125 other cases of thrombosis (venous or arterial) were notified during the same period. Of the 40 cases for which the indication was specified, 22 prescriptions were of a contraceptive nature.
