§ Mr. Ashleyasked the Secretary of State for Social Services when he expects the Committee on Safety of Medicines to have completed its review of products containing phenylbutazone and oxyphenbutazone; what form the review is taking; and who is involved in it.
§ Mr. Kenneth ClarkeThe Committee on Safety of Medicines will complete its review of the safety of products containing phenylbutazone and oxyphenbutazone very shortly. This review is being undertaken by a full committee in accordance with the procedures laid down in the Medicines Act 1968.
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§ Mr. Ashleyasked the Secretary of State for Social Services (1) if he will express the number of deaths reported in the last five years to the Committee on Safety of Medicines as being associated with products containing phenylbutazone and oxyphenbutazone in terms of the number per million prescriptions issued; and how this compares with average risk of death from the prescribing of all non-steroidal drugs;
(2) pursuant to his reply of 13 December, Official Report, c. 443–44, if he will give the number of reports made to the Committee on Safety of Medicines which associated a death with (a) phenylbutazone and (b) oxyphenbutazone in each of the last five years; and whether the incidence of such reports rose or fell after the product sheets relating to these drugs were amended following the review of them by the committee on the use of medicines in the late 1970s.
§ Mr. Kenneth ClarkeThe number of deaths reported as suspected adverse reactions associated with the use of products containing phenylbutazone and oxyphenbutazone in each of the last five years was:
Phenylbutazone Oxyphenbutazone 1979 16 3 1980 6 2 1981 5 2 1982 6 1 1983 4 0 The incidence of reported deaths per million prescriptions for these products up to 1982, the latest year for which full prescription figures are available, was as follows:
Phenylbutazone Oxyphenbutazone 1979 7.1 9.6 1980 3.9 6.1 1981 4.2 8.2 1982 6.1 4.4 The Committee on Review of Medicines reviewed products containing phenylbutazone and oxyphenbutazone in 1977. However, it is not possible to say whether the review of these products by the committee affected this incidence.
The incidence of deaths reported as suspected adverse reactions associated with the use of all non-steroidal anti-inflammatory drugs in the five years up to the end of 1982, per million prescriptions issued for those products was:
Year Number 1979 4.1 1980 3.5 1981 5.2 1982 6.9 It is important to note that a report does not necessarily indicate a causal link between death and the drug.
§ Mr. Ashleyasked the Secretary of State for Social Services how many reports of mental side effects associated with products containing phenylbutazone or oxyphenbutazone have been reported to the Committee on Safety of Medicines; and in what years the reports were made.
§ Mr. Kenneth ClarkeThe Committee on Safety of Medicines has received a total of 26 reports of psychiatric effects associated with the drugs phenylbutazone and oxyphenbutazone in the years 1965–83 as follows:236W
Phenylbutazone Oxyphenbutazone 1965 3 — 1966 — 1 1967 1 — 1968 1 1 1970 2 — 1971 1 — 1972 1 — 1975 2 — 1976 3 — 1977 3 — 1978 1 — 1979 1 — 1980 4 — 1983 — 1 TOTAL 23 3
§ Mr. Ashleyasked the Secretary of State for Social Services, pursuant to his reply of 13 December 1983, Official Report, c. 443–444, whether the 442 and 131 reports to the Committee on Safety of Medicines of deaths associated with products containing phenylbutazone and oxyphenbutazone, respectively, included any of the 1,182 deaths associated with both drugs that were referred to in Ciba-Geigy's own internal assessment of the drugs dated September 1982.
§ Mr. Kenneth ClarkeI shall let the right hon. Member have a reply as soon as possible.