§ Mr. Gareth Wardellasked the Secretary of State for Social Services if 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 associated with (a) emotional upset, (b) psychosis, (c) hyperactivity, (d) aggression and (e) behavioural problems.
§ Mr. Kenneth ClarkeNo, but as I mentioned in my reply to the hon. Member on 29 January at columns167–8 changes to the data sheet for Epilim (sodium valproate) to include information for prescribers on psychiatric adverse reactions associated with the product are being considered by the licence holder in consultation with the licensing authority. A revised data sheet should be issued soon.
§ Mr. Gareth Wardellasked the Secretary of State for Social Services what recent evaluation has been carried out by the Committee on Safety of Medicines on the use of sodium valproate; and if he will publish its latest findings.
§ Mr. Kenneth ClarkeThe Committee on Safety of Medicines constantly monitors reports of adverse reactions associated with sodium valproate and assesses whether action on its safety is required. The latest information from the committee on the safety of this drug was contained in the January 1983 edition of "Current Problems" which was issued by the Committee to doctors and pharmacists in the United Kingdom. A copy has been placed in the Library.