For citizens

For companies

For medical specialists

PRAC recommends updating measures for pregnancy prevention during retinoid use Warning on possible risk of neuropsychiatric disorders also to be included for all oral retinoids

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.

More information

The PRAC recommendations are summarised below:

Retinoid-containing medicinal products

Copyright © 2017 Bulgarian Drug Agency.
All Rights Reserved.