Recommendations include:
• Implementation of a new pregnancy prevention programme for all women of childbearing potential treated with oral acitretin, alitretinoin and isotretinoin (not considered necessary for bexarotene and oral tretinoin in light of the target population and an oncological indication subject to specialist care in the hospital setting).
• Contraindication of use of topical retinoids (adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin) in pregnant women and in women planning a pregnancy, as a precaution (although systemic absorption is negligible following topical application of retinoids).
• Inclusion of a warning about a possible risk of neuropsychiatric disorders in the product information for oral retinoids. Patients treated with oral retinoids should be monitored for signs and symptoms of depression and referred for appropriate treatment, if necessary.
The CHMP has now endorsed the PRAC recommendations and adopted the Agency’s final opinion. The CHMP opinion will be sent to the European Commission, which will take a final legally binding decision valid across the EU.
Further information will be available at national level in due course as the recommendations are implemented.