FDAnews Drug Daily Bulletin

EMA’s Safety Committee to Hold First Public Hearing in September

July 19, 2017

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee scheduled its first-ever public hearing for Sept. 26 in London, and is asking citizens to share their experiences with valproate, a treatment for epilepsy, bipolar disorder and migraines.

Also known as Depacon, Depakote and Stavzor, valproate has been used as a drug since 1962, and is on the World Health Organization’s list of essential medicines.

The EMA is currently conducting a safety review in pregnant women and women of childbearing age, at the request of the French national drug regulator, ANSM. Speakers at the public meeting will address the risks of valproate during pregnancy, measures in place to reduce the risks, and what other measures should be taken.

View today's stories