§ Mr. LoveTo ask the Secretary of State for Health (1) what assessment he has made of(a) the side-effects of the drug Epilim, (b) the circumstances in which it should not be prescribed to children, (c) the number of cases since 1995 in which children who have been given Epilim have 863W developed (i) fits and (ii) other adverse reactions, (d) the number of cases since 1995 where Epilim has been given to pregnant women and (e) the number of cases since 1995 of pregnant women who have been treated with Epilim and who have then given birth to babies with birth defects; [107571]
(2) what is the stated recommended dose of the drug Epilim when administering it to (a) adults and (b) children. [107570]
§ Ms StuartAs with all medicines, the safety of Epilim, the anticonvulsant sodium valproate, 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). A number of articles have been published in the bulletin 'Current Problems in Pharmacovigilance' to draw ADRs associated with Epilim to the attention of health professionals.
23 suspected ADRs associated with the drug Epilim, all involving children between the ages of 2-11, have been reported to the MCA/CSM from the beginning of 1995 to date. Two of these cases had fits. Reporting of a suspected adverse reaction is not necessarily evidence that the medicine caused the reaction.
In the same period in the United Kingdom, 22 cases of birth defects for women exposed to the drug Epilim during pregnancy were reported to the MCA/CSM. The product information for Epilim contains detailed advice about use in pregnancy and the prescribing physician should weigh up the risks and benefits in the individual woman's case. The number of cases since 1995 where Epilim has been given to pregnant women is not available.
Epilim is contraindicated in all patients including children where there is allergy to sodium valproate, active liver disease or family history of severe liver disease.
The daily dose of the drug Epilim as stated in the Marketing Authorisation for adults and children over 20 kilograms is gradually increased until control of fits is achieved, usually to within the range 20–30 milligrams/ kilograms body weight per day. For children under 20kg, the daily dose of 20 mg/kg of body weight per day may be exceeded in severe cases when plasma levels can be closely monitored. Full guidance on prescribing and monitoring is in the summary of product characteristics published in the Association of the British Pharmaceutical Industry Compendium of Data Sheets and Summaries of Product Characteristics.