§ The Countess of Marasked Her Majesty's Government:
When the anti-epileptic drug acid Epilim was first licensed for use in children in the United Kingdom; how many adverse drug reactions relating to hepatic and psychoneurological effects following use of this drug in children have been reported; how many deaths in children have been reported; and what measures are in force to ensure adequate surveillance. [HL2567]
86WA
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)Epilim, the anticonvulsant sodium valproate, was first licensed for use in children in 1976.
As with all medicines, the safety of Epilim is continually monitored by the Medicines Control Agency (MCA) and the independent advisory body, the Committee on Safety of Medicines (CSM) through the Yellow Card Scheme for spontaneous reporting of suspected adverse drug reactions (ADRs).
Forty-three suspected liver-related and 71 suspected neuropsychiatric reactions associated with the drug Epilim have been reported to the MCA/CSM on 88 children (aged less than 13 years) in the UK, to date. Fatal reactions were reported in 18 children. Reporting of a suspected adverse reaction does not necessarily mean that the medicine caused the reaction.
As well as spontaneous reports, the MCA reviews a number of other data sources in order to identify or confirm drug safety issues, including published articles in scientific journals, periodic safety update reports, epidemiological studies, other databases and information received from other regulatory authorities around the world. The Committee on Safety of Medicines has considered the safety of Epilim on a number of occasions with subsequent publication of advice to prescribers in the bulletin Current Problems in Pharmacovigilance.