Soriatane, prescribed in severe psoriasis, carries the risk of fetal malformations. However, only 11% of women take a pregnancy test when treatment is started.
Treatment with Soriatane is incompatible with pregnancy. This is the message that the Medicines Safety Agency (ANSM) wants to send to women who take this medicine. Acitretin (Soriatane) is indicated in particular in severe forms of psoriasis, in the event of failure of the usual therapies. But it is a powerful teratogen, that is, it can cause fetal malformations if a pregnant woman is treated.
A pregnancy test performed only in 11% of cases
However, according to a study carried out between 2007 and 2012 among 7,663 women aged 15 to 49 years, a pregnancy test was only carried out in the three days preceding the delivery of Soriatane in 11% of cases. This study by the ANSM and the National Health Insurance Fund for Salaried Workers (CNAMTS) also shows that nearly two-thirds of women did not take any pregnancy test during treatment.
A total of 357 pregnancies occurred during treatment or within two years of discontinuation, of which nearly 40% were terminated (by medical, voluntary or spontaneous miscarriage). For 53 of these pregnancies, the delivery of acittretin occurred during pregnancy.
The Medicines Agency has decided to reserve the initial prescription for dermatologists. She also reminds pharmacists that no dispensing should be carried out if the negative result of the pregnancy test is not mentioned in the patient’s health record.
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