§ Mr. Ashleyasked the Secretary of State for Social Services if he will list the information he has as to the drug products recommended for babies which sell at or above a level of 10 million doses a year, indicating their use.
§ Mr. Kenneth ClarkeAlthough we know how many prescriptions are issued by general practitioners for individual products, we have no information on the proportion of those prescriptions which is for use in babies; nor do we know the numbers of such products which are sold off-prescription. We therefore cannot say what products sell 10 million doses or more a year for use in babies.
§ Mr Ashleyasked the Secretary of State for Social Services if he will request the Committee on Safety of Medicines to require companies expecting to sell a drug at a level of or above one million doses annually for babies, to provide evidence of safety at a higher level than normal, and such that adverse reactions are no more frequent than one in a thousand babies given the product; and if he will estimate the number of babies that would need to be included in a research study to produce statistically sound evidence of safety at this level.
§ Mr. Kenneth ClarkeSafety data are assessed with reference to the proposed uses of individual drugs. It would not be appropriate to set rigid minimum standards for such data.
§ Mr. Ashleyasked the Secretary of State for Social Services when, and in what context, the Committee on Safety of Medicines considered the safety of products containing dicyclomine apart from those in May 1983 and July 1983 referred to in the answer on 11 March, Official Report, columns 72–73; what was the nature of the 36 adverse reactions reported to the Committee since 1969; and to what factors he attributes the large increase in the number of reports made in 1983 and 1984.
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§ Mr. Kenneth ClarkeThe safety of products containing dicyclomine was considered by the Committee on Safety of Medicines whenever an application for a relevant product licence was referred to them. In addition Debendox, which contained dicyclomine until 1982, was considered by the Committee on eight occasions between June 1978 and February 1983.
The adverse reactions involving babies under six months old reported to the committee as associated with dicyclomine products were: apnoeia; drowsiness; hyper-ventilation; rashes; oculogyric crisis; addiction; floppiness; convulsion; deafness; hyperactivity; syncope; stupor and dyskinetic movement. It is very important to note that a report does not necessarily demonstrate a causal relationship between the reaction and the drug concerned. We do not know why there was an increase in adverse reaction reports for these products in 1983 and 1984.