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Isotretinoin: too many pregnancies still at risk

Despite a series of measures, unborn children are still being exposed to isotretinoin during pregnancy, with a risk of serious malformations and/or neuropsychiatric disorders.

Isotretinoin is used in acne, either by topical application or by oral administration. It is a retinoid vitamin A derivative and is highly teratogenic. One-quarter of children whose mothers were exposed during pregnancy develop multiple malformations (craniofacial, cardiac, and nervous system abnormalities). Since the 1990s, neuropsychiatric developmental disorders have also been reported in children exposed in utero to isotretinoin, without any visible malformations at birth.

This risk has been pointed out in official drug information documents in the United States since 2010. In early 2021, the French Health Products Agency (ANSM) issued an alert relating to this risk. However, despite a prevention programme (involving patient information packs, restriction of initial prescribing to dermatologists, compulsory pregnancy tests, etc.), the number of pregnancies exposed to isotretinoin is not falling in France and is still around 175 per year. Since mid-2021, the ANSM has therefore recommended that oral isotretinoin (Procuta° or other brands) be prescribed following two spaced consultations, to allow time for the patient to reflect, and that reimbursable emergency contraception and male contraceptives be provided for women on oral contraceptives.

In addition, taking isotretinoin exposes women and men to adverse effects on mental health, with a risk of suicide particularly during the first months of treatment and for the first months after stopping treatment. ANSM recommends monthly follow-up to monitor these risks.

Emergency contraception is also warranted after expulsion of an intra-uterine device if sexual intercourse has taken place within a few days prior to expulsion, and it is wise to extend follow-up for at least one month after stopping isotretinoin.

All these measures should also apply for topical isotretinoin and to other oral retinoids: acitretin (Soriatane°), alitretinoin (Toctino° or other brands), bexarotene (Targretin°) and tretinoin (Vesanoid°).

©Prescrire 1 April 2022

Source: "Isotretinoin: developmental neuropsychiatric disorders, without visible malformations at birth" Prescrire International 2022; 31 (236): 103-104. Subscribers only.

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See also:

"Topical retinoids:
contraindicated in
pregnant women"
Prescrire Int 2019;
28 (202): 73.
Pdf, subscribers only
"Oral isotretinoin: patient
information to prevent risks"
(April 2020)
Free

"Pregnancy: drugs to avoid"
(August 2013)
Free

"Too many pregnant
women are exposed to
contraindicated drugs"
(February 2010)
Free


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