EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of retinoid1 medicines and has recommended updating the measures for pregnancy prevention and including a warning on the possible risk of neuropsychiatric disorders (such as depression, anxiety and mood changes).
During its review, the PRAC assessed the available data including published literature and post-marketing reports of side effects, and also sought the views of patients and healthcare professionals in a dedicated stakeholder meeting and a successive written consultation.
The PRAC recommendations are summarised below: