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Isotretinoin and acne: prevent major risks
to the foetus

The use of isotretinoin is heavily circumscribed, so as to limit the major risk of foetal malformation.

Retinoids, derived from vitamin A, can cause serious foetal malformation when taken orally by a pregnant woman, but also when applied topically. One retinoid, oral isotretinoin is marketed as a treatment for some forms of acne, particularly severe and persistent acne. Acne is generally a benign disorder and does not warrant putting the foetus at risk.

In France, on the first prescription, the practitioner must assess the patient's level of understanding of the risk to the foetus and the need for contraception if she is of reproductive age. The patient must have been using at least one method of contraception for no less than a month, and must sign a care and contraception agreement. A pregnancy test must have been carried out around 3 weeks after she last had unprotected sexual relations, and another must be carried out at the time of prescription or during the 3 days before. The practitioner must state the date of this second test on the prescription. The duration of the treatment prescribed is limited to one month.

The pharmacist must check all the above on the prescription. The treatment must be dispensed within 7 days of the date of prescription. Every 28 days, the doctor must re-assess the need for a pregnancy test, and note any observations on the prescription, for the pharmacist's information. Contraception must be continued for at least one month after treatment stops, and a pregnancy test must be carried out 5 weeks afterwards.

©Prescrire June 2006

Source: "Isotrétinoïne orale : prescription et dispensation en 2006" Rev Prescrire 2006 ; 26 (272) : 334.

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