§ Mr. John Morrisasked the Secretary of State for Social Services (1) whether any measures have been taken to warn physicians and surgeons who may have cause to prescribe sodium valproate in any of its forms of its possible adverse effects; and if he is satisfied with these measures;
(2) whether the drug sodium valproate is at present being prescribed as an approved National Health Service drug; if so, whether its approval is in the same terms as it was one and two years ago, respectively; and whether he will set out the terms of such approval;
(3) what recent evaluation has been carried out by the Committee on Safety of Medicines on the use of sodium valproate; and whether he will publish its findings.
§ Dr. Vaughan[pursuant to the reply, 20 July 1981]: Doctors employed within the National Health Service are free to prescribe any medicinal product, including sodium valproate, they consider most appropriate for their patients' treatment. Sodium valproate—epilim—is licensed under the Medicines Act 1968 for the treatment of epilepsy. The approved indications for use, dosage and administration, which have not changed in the past two years, are included in the manufacturer's data sheet which provides advice to all medical practitioners. Between 1979 and 1980 a few minor changes were made in the section of the data sheet for epilim concerning adverse reactions. These included additional information about possible liver dysfunction.
Following published reports of adverse reactions the Committee on Safety of Medicines has reviewed scientific evidence concerning the safety of sodium valproate. In the light of its advice, the licensing authority has recently approved a variation to the approved data sheet to include additional warnings regarding blood disorders, liver failure, hyperammonaemia and acute pancreatitis. The revised data sheet is being made available to doctors by the company and doctors' attention has been drawn to the changes in "Current Problems", No. 6, published recently by the CSM and distributed to all doctors. A copy of "Current Problems" is available in the Library of the House.