Isotretinoin is highly teratogenic. There is a greatly increased risk of severe and life-threatening birth defects if the patient becomes pregnant while taking products containing isotretinoin, regardless of the dosage and period of use.
Isotretinoin and teratogenicity
Incident data |
Description |
|---|---|
Case: 2023-13654 Age group: term newborn infants Gender: male Medicinal products: unknown Active substance(s): isotretinoin Indication: acne ADRs: dysmorphic facial features, microcephaly, developmental delays, muscle tone regulation disorders, retinal detachment on both sides Outcome: not recovered |
The child’s mother took a product containing isotretinoin once a day up to the 7th week of pregnancy. In the first days and weeks after the birth, the newborn baby exhibited a serious developmental delay with muscle tone regulation disorder, athetoid movement pattern, microcephaly, abnormal facies and subsequent retinal detachment on both sides. In a differential diagnosis, the treating physicians assumed that these were teratogenic symptoms in the context of the mother’s treatment with isotretinoin during early pregnancy. |
Summary and recommendation
Isotretinoin is a highly teratogenic medicinal product. Its use during organogenesis increases the risk of miscarriage and can cause the characteristic retinoid syndrome: malformation of the ears (outer ear malformations such as anotia or microtia, agenesis or stenosis of the auditory canal), face and palate development disorders, micrognathia, cardiovascular anomalies (conotruncal heart defects), thymic anomalies, as well as CNS anomalies, ranging from neurological damage involving the eyes and inner ear up to hydrocephalus. Intelligence deficits have also been observed in children without noticeable malformations. The risk of malformation following exposure in the first trimester is up to 20%.
Unlike oral isotretinoin it is assumed that when used correctly, topical retinoids only result in low systemic exposure, as they are minimally absorbed through the skin. However, individual factors (e.g. skin lesions, excessive use) can increase systemic exposure. Therefore, both oral and topical administration are contraindicated for women planning pregnancy, unless all the conditions of the pregnancy prevention programme are complied with (including that the patient has severe acne, understands the teratogenic risk and the danger to the unborn child should she become pregnant during treatment and for one month afterwards).
If a patient becomes pregnant during the treatment, the treating physicians and the patient should discuss whether it is advisable to continue with the pregnancy. If a decision is made to continue, it is recommended to continually monitor the heart, facial bones and central nervous system.
Statutory duty of healthcare professionals to report adverse drug reactions (ADRs)
In Switzerland, healthcare professionals who are authorised to dispense or administer medicinal products are obligated to report severe and/or previously unknown side effects. Reports to Swissmedic can be entered and sent in the Electronic Vigilance Reporting Portal “ElViS” (ElViS login).
Supplementary information
(1) Medicinal product information for Curakne®, Roaccutan®, Tretinac®:
Information for healthcare professionals
(2) (1) Fetal retinoid syndrome. https://rarediseases.org/rare-diseases/fetal-retinoid-syndrome/
(3) Risk information
Reporting adverse drug reactions
Electronic reports via the ElVis portal