§ Mr. Ashley
asked the Secretary of State for Social Services, pursuant to his answer, Official Report, 14, July, if he will list the five drugs which have had the largest cumulative number of adverse reaction reports over the last six months; and if he will indicate which of these have resulted in deaths possibly associated with the drug.
§ Mr. Hayhoe
[pursuant to his reply, 23 July 1986]: The five drugs are Fenbufen, Diphtheria/Pertussis/Tetanus Vaccine, Nifedipine, Enalapril Maleate and Piroxicam. In this period, deaths have been reported in association with Fenbufen, Enalapril Maleate and Piroxicam. This information is based on the reports of adverse reactions received by the CSM between 1 January and 30 June 1986; the reports relate to events occurring over a considerably longer period. The heading of Diphtheria/Pertussis/Tetanus vaccine refers to reports associated with all such vaccinations, whether administered singly or in combina tion. I am advised that it is very important to note that a report does not necessarily indicate a causal relationship between a medicinal product and the reported reaction, and that considerable caution should be exercised in interpreting the volume of such reports in the absence of data on prescription volumes and other relevant factors, and over an arbitrary period when special factors may affect the rate of reporting.
§ Mr. Ashley
asked the Secretary of State for Social Services, pursuant to the answer, Official Report, 14, July, 757W column 422, of the eight drugs whose licences or certificates were withdrawn, how many had (a) been on the market for over five years and (b) had at some time over 1 million prescriptions issued for them in one year; and for the drugs falling into either of these two categories, how many months the committee spent in evaluating safety before the decision was taken to revoke the licence or certificate.
§ Mr. Hayhoe
[pursuant to his reply, 23 July 1986]: Of the eight drugs discussed by the Committee of Safety of Medicines in the calendar years 1981 to 1985, whose product licences on clinical trails certificates were revoked on the advice of the committee, four had been on the market for longer than five years, and none had in excess of 1 million prescriptions recorded in any one calendar year. Continuous evaluation of the safety profile of all drugs begins as soon as the licence or certificate is granted.