english.prescrire.org > Spotlight > Archives : 2010 > Acne: new measures concerning isotretinoin

Spotlight: Archives

Every month, the subjects in Prescrire’s Spotlight.

2010 : 1 | 30 | 60 | 90

Acne: new measures concerning isotretinoin

In view of the major risk of fetal malformation, new measures have been introduced in France concerning the prescription of isotretinoin for women.

Isotretinoin is marketed as a treatment for some forms of severe acne. Due to its teratogenicity (risk of malformation in newborns if taken during pregnancy), its prescription and dispensation are strictly regulated so as to avoid this drug being taken during pregnancy.

Despite these measures, each year a worrying number of pregnant women are exposed to isotretinoin. And so at the end of 2009, Afssaps, the French Health Products Safety Agency, put in place the "patient booklet", a patient-healthcare professional liaison resource which summarises all the necessary information and tests for the prescription and dispensation of oral isotretinoin. Each prescription carries the signature and stamp of the doctor and the pharmacist each time the drug is prescribed or dispensed.

These new provisions are welcome, but it is a pity that this resource is distributed solely by pharmaceutical companies and only to dermatologists. General practitioners have to request it specifically from drug companies.

Furthermore, 3 of the 4 drugs based on isotretinoin have a brand name that is not very informative as it does not mention the international nonproprietary name isotretinoin. Afssaps and pharmaceutical companies are urged to remedy this quickly.

©Prescrire April 2010

Source: "Isotrétinoïne orale. Un carnet de suivi pour chaque patiente traitée" Rev Prescrire 2010; 30 (317): 182.