Oral isotretinoin is a vitamin A derivative commercialised for the treatment of severe acne.

Isotretinoin can harm the development of the unborn child: it causes cranofacial, cardiac and central nervous system damage in around 25% of babies exposed during pregnancy. Patients are also at risk of developing psychological disorders such as depression and suicidal behaviour.

To provide more comprehensive patient information on these severe adverse effects, at the beginning of 2012, the French Health Products Agency (ANSM, formerly Afssaps) posted a “patient leaflet” on its website entitled “What you need to know before beginning treatment with oral isotretinoin”.

This document is designed to be printed out and given by doctors to patients before commencing treatment with oral isotretinoin. It seeks to make women patients of reproductive age aware of the risk of serious birth defects in the unborn child associated with taking oral isotretinoin during pregnancy and of the preventive measures before and after treatment, which include signature of a treatment and contraception agreement; use of an effective method of contraception; carrying out a monthly pregnancy test during treatment and another one 5 weeks after the treatment ends; bringing a “patient record” to each consultation and showing it to the pharmacist on collecting each prescription, and returning any unused capsules to the pharmacy.

This leaflet also draws attention to the adverse psychological effects of oral isotretinoin and the need for patients and their families to be on the alert for behavioural changes.

This is a welcome initiative: let us hope that it will boost the application of preventive measures already in place but which have not proved very effective so far.

©Prescrire 1 September 2012

Source: "Isotrétinoïne orale. Un "feuillet patient" pour renforcer la prévention de certains risques" Rev Prescrire 2012; 32 (344): 419.