§ Lord Morris of Manchester
asked Her Majesty's Government:
How many adverse incidents relating to the use of Factor VIII and Factor IX blood products used for haemophilia treatment were reported in each year from 1970 to 1987 in England. [HL2508]
§ Baroness Andrews
Reports of adverse drug reactions to medicines are collated by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM) through the spontaneous reporting scheme, the Yellow Card Scheme.
During the period 1970–87 no reports of suspected adverse drug reactions were reported to the MHRA/ CSM, associated with Factor IX in the United Kingdom.113WA
In the UK, a total of 89 reports of suspected adverse drug reactions were reported to be associated with Factor VIII during the period 1970–87. The following table lists the number of reports received by year:
Year Number of reports received 1970 0 1971 0 1972 0 1973 0 1974 3 1975 0 1976 2 1977 8 1978 10 1979 20 1980 7 1981 17 1982 2 1983 3 1984 1 1985 7 1986 7 1987 2 Total 89
The figures provided relate to the number of reports received. Some reports may contain more than one reaction.
The reporting of a reaction does not necessarily mean that it has been caused by the drug. Many factors have to be taken into account when assessing causal relationships including temporal relationship, the possible contribution of concomitant medication, and the underlying disease.