An EU review of all available data on safety and efficacy for retinoid medicines concluded that balance between benefits and risks for retinoids remains favourable. Review recommended that educational materials for patients and healthcare professionals about pregnancy prevention measures should be simplified and made consistent and warnings about neuropsychiatric disorders harmonised across oral retinoid medicines.
Women and girls of childbearing potential taking oral retinoids to treat dermatological conditions must be supported by a Pregnancy Prevention Programme. The retinoid medicines that have a Pregnancy Prevention Programme as a condition of the licence are oral isotretinoin for severe acne, oral acitretin for severe psoriasis, and oral alitretinoin for chronic severe hand eczema.
Educational materials to support healthcare professionals and female patients using acitretin, alitretinoin, and isotretinoin have been simplified and are now consistent, irrespective of which brand of medicine a patient receives. The educational materials are:
- prescriber checklist – to be used by the dermatologist, specialist dermatology nurse, or a prescribing GP with a special interest in dermatology to record discussion of risks with patient. A copy should be provided to patient
- patient card – to be given by dermatologist, specialist dermatology nurses, or prescribing GP to reinforce key safety messages around risks
- pharmacist checklist – to be used as an aid memoir by pharmacists when dispensing oral retinoid medicines.
Systemic exposure is thought to be negligible following application of topical retinoids during pregnancy. However, since risk cannot be excluded, use of topical retinoids is contraindicated during pregnancy. Women and girls should be advised not to use topical retinoids if they are planning a pregnancy and to use effective contraception to minimise risk of accidental exposure in pregnancy if they are of childbearing potential.
MHRA has monitored reports closely and since 2015 advice has been present in Patient Information Leaflet for isotretinoin that patients should discuss any history of mental illness with their doctor before taking isotretinoin.
Cases of newly diagnosed depression, worsening of existing depression, and anxiety reported with oral retinoids. The limitations of available data did not allow review to establish a clear causal association between risk of neuropsychiatric disorders and use of oral retinoids. However, patients with severe skin conditions may be more likely to develop neuropsychiatric disorders due to nature of disease. The review therefore concluded that prescribing information for oral retinoids should include a warning to ensure patients are informed about possible risk and what to do if symptoms occur.
Therefore, advice about monitoring for neuropsychiatric disorders has been made consistent for alitretinoin and isotretinoin products, and added to product information for acitretin, tretinoin and bexarotene. Advice about monitoring for neuropsychiatric disorders. All patients treated with an oral retinoid should be monitored for signs of depression or suicidal ideation and refer for appropriate treatment, if necessary. Particular care needs to be taken in patients with history of depression. Healthcare professionals should discuss with patients taking an oral retinoid that they may experience changes in their mood or behaviour and to talk to their doctor if their mood is affected. Patients should also be encouraged to let family and friends know they are taking an oral retinoid so they can look out for any change in mood.
For topical retinoids, review concluded that data show systemic exposure is negligible following topical application and is unlikely to be associated with an increased risk of neuropsychiatric disorders .
Healthcare professionals are advised to report suspected ADRs associated with retinoid medicines via the Yellow Card Scheme.