New pregnancy prevention measures for retinoid products

Further restrictions have been announced on the use of retinoid medicines in pregnancy, after a review by the EMA confirmed that all oral retinoids can harm the unborn child.

Oral retinoids can harm the unborn child and must not be used during pregnancy. |
Oral retinoids can harm the unborn child and must not be used during pregnancy. |

Prescribing information for retinoid medicines in MIMS has been updated to reflect strengthened recommendations for pregnancy prevention issued by the EMA, as well as new warnings about possible neuropsychiatric effects.

Pregnancy prevention programmes

The EMA's review confirmed that oral retinoids (acitretin, alitretinoin, bexarotene, isotretinoin and tretinoin) are highly teratogenic and must not be used during pregnancy. Oral acitretin, alitretinoin and isotretinoin must now only be used in women of childbearing potential when all the conditions of a pregnancy prevention programme (PPP) are met.

The PPP conditions include:

  • an assessment of each woman’s potential for becoming pregnant
  • pregnancy tests before starting treatment, during treatment and after treatment
  • the need for at least one effective method of contraception during and after treatment
  • a ‘risk acknowledgement form’ for patients and prescribers to go through and confirm that appropriate advice has been given and understood.

Oral products containing acitretin, alitretinoin or isotretinoin are now subject to additional monitoring so all suspected reactions to these medicines should be reported.

For topical retinoids (adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin), the available data show that systemic absorption is negligible following topical application and that these products are unlikely to cause fetal harm. However, as a precaution, topical retinoids are contraindicated in pregnancy and in women planning a pregnancy.

A PPP was not considered necessary for topical bexarotene or oral tretinoin given their specialist oncological indications.

Neuropsychiatric warning

The EMA review also investigated reports of depression, depression-aggravated anxiety and mood alterations in patients taking oral retinoids.

Owing to conflicting evidence and the limitations of published studies, it was not possible to identify a clear increase in the risk of neuropsychiatric disorders in people who take oral retinoids compared to those who do not. However, since severe skin disorders themselves increase the risk of psychiatric disorders, patients treated with oral retinoids should be monitored for signs and symptoms of depression and advised to report such symptoms. Particular care should be taken in patients with a history of depression.

For topically applied retinoids, systemic absorption is negligible, and unlikely to result in psychiatric disorders.

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