Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids
The European Medicines Agency (EMA) has completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur will be included in the prescribing information for oral retinoids (those taken by mouth).
Retinoids include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin. They are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including severe acne and psoriasis. Some retinoids are also used to treat certain forms of cancer.
The review confirmed that oral retinoids can harm the unborn child and must not be used during pregnancy. In addition, the oral retinoids acitretin, alitretinoin and isotretinoin, which are used to treat conditions mainly affecting the skin, must be used in accordance with the conditions of a new pregnancy prevention programme by women able to have children.
Topical retinoids (those applied to the skin) must also not be used during pregnancy, and by women planning to have a baby.
Regarding the risk of neuropsychiatric disorders, the limitations of the available data did not allow to clearly establish whether this risk was due to the use of retinoids. However, considering that patients with severe skin conditions may be more vulnerable to neuropsychiatric disorders due to the nature of the disease, the prescribing information for oral retinoids will be updated to include a warning about this possible risk. Available data suggest that topical retinoids do not carry a risk of neuropsychiatric side effects, and therefore no additional warnings need to be added to the prescribing information.
The review of retinoids was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which assessed the available data including published literature, post-marketing reports of side effects and additional information collected from stakeholder meetings and written submissions.
The EMA’s Committee for Medicinal Products for Human use (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.