Sodium Valproate

Mr. Syms
To ask the Secretary of State for Health (1) what medical evidence there is of any negative side effects of Epilim (sodium valproate) on (a) embryos and (b) those under the age of 18 years;

(2) how many compensation payments have been made for medical problems resulting from the prescribing of Epilim (sodium valproate) in the NHS;

(3) what advice is given in the NHS on the prescribing of Epilim (sodium valproate) to pregnant women.

Mr. Mike O'Brien
The safety, efficacy and quality of every medicine is thoroughly evaluated by the Medicines and Healthcare products Regulatory Agency as part of the licensing procedure and its safety is monitored continuously while it is on the market.

Animal studies have shown that Epilim has teratogenic effects. In humans, studies have shown an association between pregnancy exposure and neural tube defects such as myelomeningocele and spina bifida.

The product information which consists of the Summary of Product Characteristics for healthcare professionals and the Patient Information Leaflet contains extensive information to support the appropriate use of the medicine. These documents are available on the internet at www.medicines.org.uk. This information is also reflected in the prescribing advice provided in the British National Formulary, which is sent to all doctors within the NHS.

The product information for Epilim contains detailed advice in relation to the use of Epilim during pregnancy. It is currently advised that women of childbearing potential should not be started on Epilim without specialist neurological advice and the benefits of Epilim use should be weighed against the risks to the foetus.

Information on possible side effects which may occur during treatment with Epilim are also outlined in the product information. These side effects may have been reported during clinical trials or since Epilim has been marketed and have been assessed as either having a causal association or a strong suspicion of an association. Of the known side effects it is recognised that children who are treated with Epilim are at particular risk of developing liver damage and pancreatitis.

The NHS Litigation Authority (NHSLA) handles negligence claims against National Health Service bodies in England. However, due to the way that data are organised on the NHSLA's database, this answer could be provided only at disproportionate cost.