More precautions. This is what the National Medicines Safety Agency recommends on May 5 (ANSM) for any medication for severe acne containing isotretinoin. First marketed under the Roaccutane brand until 2010, this molecule is now used in several generics: Curacné, Procuta and Acnétrait.
This molecule exposes to a very high risk (25 to 30%) of fetal malformations in the event of pregnancy and psychiatric risks for the person treated.
This is why its use during pregnancy is an absolute contraindication. And the use of a method of contraception “effective even in the absence of sexual activity“was already a condition.”In case of oral contraception“(pill), the agency now recommends to prescribe in addition”systematic emergency contraception and condoms“, in order to minimize the risk of pregnancy.
Clearly, the contraception recommended in the context of treatment with isotretinoin is either an IUD or a progestogen implant, or two other complementary methods of contraception (for example pill plus condom), recalls the ANSM.
Read also: Isotretinoin: a dangerous treatment for pregnant women
Two consultations before the prescription
Then, the ANSM now recommends “a time for reflection “ before starting treatment. Two consultations will be necessary before any initiation of treatment: “an information consultation, followed by a prescription consultation“, details the agency.
The initial prescription was already very framed and reserved for dermatologists. It cannot be done only in the event of failure of conventional treatments, for a period limited to six months.
The health authority finally recommends “monthly medical monitoring of all patients“,”including men“. This is already the case today, but only for patients of childbearing age, with the performance of a test to verify “the absence of any pregnancy“.
This regular follow-up should allow doctors to “ensure the patient’s mental health“, and patients and their relatives must”be attentive to the appearance of signs of a psychological / psychiatric nature, in particular a depressive syndrome“.
Reinforce patient information
These recommendations “are based on the proposals of a committee“experts set up in March 2021 to improve the safety of this drug.
This committee also formulated other proposals, such as “the framework of the initial prescription to avoid unjustified uses” or “more educational tools“and more accessible to improve patient information. ANSM specifies that it has committed to these points”work with the stakeholders concerned“.