§ Miss Richardson
asked the Secretary of State for Social Services, (1) when the Committee on Safety of Medicines last evaluated the use of the drug Epilim, valproic acid; and what were its findings;
(2) whether there have been any changes in the section of the data for Epilim, valproic acid, since 1980;
(3) how many deaths have been reported for each of the last five years of persons suffering from epilepsy who have been prescribed the drug Epilim, valproic acid;
(4) whether the Committee on Safety of Medicines has had consultations with the United States Committee on Drugs concerning the use of the drug Epilim, valproic acid; and what were the results;
(5) whether he will instigate a public inquiry into the use of the drug Epilim valproic acid.
§ Mr. Geoffrey Finsberg
[pursuant to his reply, 18 April 1983 c. 43–4]: I refer the hon. Member to my reply to the hon. Member for Swansea, West (Mr. Williams) on 9 March 1983—[Official Report, Vol. 38 c. 412]. In January this year the Committee on Safety of Medicines advised doctors about the specific question of possible hazard to the foetus when the drug is used in pregnancy. In "Current Problems" No. 9 it advised that there was no clear evidence that any of the group of drugs, of which Epilim is one, was safer or more dangerous in this respect than any other.
The United States Food and Drug Administration has considered the safety of sodium valproate in pregnancy and has taken similar action.
The CSM has registered, to 15 April 1983, a total of 19 reports of adverse reactions associated with sodium valproate in which the patient had died and death was thought to have been due to the suspected reaction. I must emphasise that these reports do not necessarily indicate a causal relationship in all cases. The number of such reports for the last five years is as follows:403W
Number 1978 1 1979 2 1980 3 1981 4 1982 4 1983 0
I am not aware of any scientific evidence to suggest that further action is required and do not consider that a public inquiry is necessary.