§ Mr. Ashleyasked the Secretary of State for Social Services whether the increased effect of Opren dosage upon plasma levels according to the age of the patient was known to the Committee on Safety of Medicines; from what research sources; and what assessment was made by them of it.
§ Mr. Kenneth ClarkeThree studies relating to the measurement of levels of the drug in the blood plasma of elderly people were made available to the Committee on Safety of Medicines by Lilly Industries Ltd. in October 1981. These were by Hamdy et al, Kamal and Koch and a preliminary report of a study in Indianapolis and Basingstoke. These studies presented no evidence of harm to the elderly patients, but did suggest that the drug might accumulate in elderly people. The evidence from Basingstoke and Indianapolis was, however, conflicting, and the committee decided that it would wish to see further evidence before deciding if any dosage change was necessary for elderly patients. This evidence was received in August 1982 after the licence for Opren had been suspended.