EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of retinoid 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 recommendation will now be sent to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s opinion. Further details including advice for patients and healthcare professionals will be published at the time of the CHMP opinion.
The press release is available by clicking here and includes a summary of the PRAC recommendations.
For more information on the European regulatory system for medicines, please consult our brochure.
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