Spread Valporate Warnings Wider, EMA Told in First-Ever Public Hearing

Warnings about the risk of valporate to babies in the womb may not be fully reaching the target audience of pregnant women considering use of the drug, participants said in the first-ever public hearing held by the European Medicines Agency.

Valporate, a treatment for migraine headaches, epilepsy and bipolar disorder, can cause malformations and impede neurological development in babies in the womb. Concerns about the effectiveness of measures to minimize the risk throughout the European Union prompted a review of those efforts by the EMA’s Pharmacovigilance Risk Assessment Committee.

The public hearing, which formed part of the review, was a first for the EMA. The hearing was held in September at the EMA’s London headquarters, and drew an audience of 28 patients and patient representatives, 19 healthcare providers and academics, 11 industry representative and seven members of the media, the EMA said. Of those, 25 spoke at the hearing.

Speakers suggested adding visual reminders of the risks to the packaging of valproate products and conducting regular reviews of the informational campaigns to make sure no woman who takes the medicine is unaware of the risks.