[Exposure to isotretinoin during pregnancy in France: 25 years of follow-up].

Because of its teratogenicity, isotretinoin is contraindicated in pregnant women and also among women of childbearing age in the absence of effective contraception. The objective of this work is to summarize the results of studies assessing the effects of regulatory measures successively implemented in France since 1996 to prevent foetal exposure to isotretinoin. The five pharmacovigilance studies have shown persistence of pregnancies exposed to isotretinoin, with an estimated incidence in the latter study, between 0.32 and 0.95 per 1000 treated women of childbearing age. The strengthening of the prevention plan of pregnancies, established in France in March 2010, seems to have resulted in a decrease in the incidence of pregnancies exposed, but this trend needs to be confirmed. However, these pregnancies are almost preventable, because most of them are explained by the non-compliance with the conditions of prescribing and dispensing. Then it seems mandatory to not deliver oral isotretinoin if it is not prescribed in accordance with the prescription laid down by the authorities.