Acitretin is, marketed in France under the name Soriatane, has been a retinoid (derivative of vitamin A) since 1988. It is indicated in severe forms of psoriasis as a single treatment or in combination with puvatherapy. Its prescription is very limited to protect women from malformations during their pregnancy.
Heavy treatment
Like all systemic retinoids, acitretin is a powerful teratogen (which can create malformations in children) requiring special prevention measures.
The ANSM reminds that healthcare professionals must inform themselves and ensure that their patients are on effective contraception throughout the duration of treatment and for 2 years after stopping it.
They must also prescribe them for a pregnancy test within 3 days before each monthly prescription, then 2 months after stopping treatment and during the 2 years following this stopping on the dates they have agreed.
The ANSM also confirms that pharmacists cannot deliver this treatment without mentioning the negative pregnancy test entered in the health record, compulsory for each consultation and for each purchase.
Patients should not consume alcohol during treatment and for 2 months after stopping it.
An alarming record
However, a study carried out between 2007 and 2012 among 7,663 women aged 15 to 49 years in the initiation of treatment with acitretin reveals an alarming record of compliance with safety measures.
Indeed, the realization of the pregnancy test was observed in only 11% of cases. During treatment, almost two-thirds of women (65%) did not have a pregnancy test; after stopping treatment, 4 out of 5 women (77%) did not have a pregnancy test within two years of stopping treatment.
In addition, 357 pregnancies were observed during treatment or within two years of discontinuation, of which nearly 40% were terminated (medical termination of pregnancy, voluntary termination of pregnancy or spontaneous miscarriage). For 53 of these pregnancies, the delivery of acitretin occurred during the pregnancy.
In this context, the ANSM recalls “the importance of properly informing any woman of childbearing age that a processing by Soriatane is incompatible with pregnancy, throughout the duration of treatment as well as during the 2 years following this treatment, because of the risk of storage in the fats of a teratogenic metabolite, the formation of which is favored by the consumption of alcohol ”and put in place new measures. The initial prescription will be reserved for dermatologists and can only be renewed for one year, after which only this specialist will be able to issue a prescription again.