2077 - Sodium Valproate (Answered)

Kate Green
To ask the Secretary of State for Health, what information he holds on what knowledge his Department had of the emergence of risks associated with sodium valproate within the first five years following first prescription of that drug.

George Freeman

Sodium valproate was licensed in the United Kingdom in 1972 as a treatment for epilepsy and was marketed in 1974 for general prescription. The risks known to be associated with sodium valproate at that time were described in the data sheet first published in 1975 in the Association of British Pharmaceutical Industry (ABPI) Data Sheet Compendium. A copy is attached.

The safety of sodium valproate was monitored after licensing using data from the Yellow Card Scheme, which was set up in 1964 to collect reports of suspected adverse reactions to medicines. The data sheet published in the 1980-81 ABPI Data Sheet Compendium reflects the safety profile of sodium valproate following five years of availability on general prescription. A copy is attached.