PRAC holds its first public hearing for review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age.

There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that European Union (EU)-wide risk minimisation measures currently in place do not seem to be sufficiently effective.

During its September meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) Patients, carers, doctors, pharmacists and academia shared their experience with valproate – a medicine that treats epilepsy, bipolar disorder and migraine.

EU referral procedures for safety reasons – urgent EU procedures:

• Newly triggered procedures – None

• Ongoing procedures – None

• Procedures for Finalisation – None

• Planned public hearings

First PRAC public hearing

EU referral procedures for safety reasons – other EU referral procedures

• Newly triggered procedures

• Ongoing procedures

• Procedures for Finalisation

• Planned public hearings

• Article 5(3) of Regulation (EC) No 726/2004: PRAC advice on CHMP request

EU referral procedures for safety reasons – other EU referral procedures

• Newly triggered procedures: None

• Ongoing procedures: The PRAC adopted a list of outstanding issues to be addressed by the marketing authorisation holders for the following referrals
Article 20 Referral: Daclizumab – ZINBRYTA – EMEA/ H/A-20/1456
Article 31 Referral: Fluoroquinolones for systemic and inhalation use: ciprofloxacin; enoxacin; flumequin; levofloxacin – QUINSAIR, lomefloxacin; moxifloxacin; norfloxacin; ofloxacin; pefloxacin; prulifloxacin; rufloxacin
Article 31 Referral: Quinolones for systemic and inhalation use: cinoxacin; nalidixic acid; pipemidic acid – EMEA/H/A-31/1452
Article 31 Referral: Valproate and related substances: sodium valproate, valproic acid, valproate semisodium, valpromide

• Procedures for finalisation: None • Re-examination procedures: Article 31 Referral: Paracetamol, tramadol – Review of the benefit-risk balance of paracetamol modified release following notification by Sweden