§ Mr. Alan Williams
asked the Secretary of State for Social Services, further to his answer of 9 March, Official Report, c. 412, about sodium valproate, how many reports were received before the consideration of the issue by the Committee on Safety of Medicines in 1980 and how many since; what has been the severity of the reported reactions; and how many deaths have been reported.
§ Mr. Geoffrey Finsberg
[pursuant to his reply, 15 March 1983, c. 149]: The following table shows the number of reports of adverse reaction associated with sodium valproate registered by the Committee on Safety of Medicines when the suspected reaction significantly affected the brain, liver or pancreas. I must emphasise that these reports do not necessarily indicate a causal relationship in all cases. All of these categories of reaction are considered serious and potentially life-threatening.429W
Suspected Reaction Prior to 1 January 1980 January 1981 to 10 February 1983 Number of reports Number of deaths Number of reports Number of deaths 1. Serious reactions affecting the brain (a) encephalopathy 2 — 1 — (b) Hyperanimonaemia 1 1 5 1 2. Serious liver disorders 9 6 14 4 3. Pancreatitis — — 4 2