§ Mr. AshleyTo ask the Secretary of State for Health how many deaths and adverse reactions have been reported since the introduction of human insulin; and if he will make a statement.
§ Mr. FreemanSince December 1982 the Committee on Safety of Medicines has received just over 100 reports of adverse reactions which may be associated with human insulin. In four of these cases the patient died. A report of a suspected adverse reaction does not necessarily mean there is a causal relationship with the drug so it does not follow, that human insulin was responsible for the reported deaths.
§ Mr. AshleyTo ask the Secretary of State for Health which companies manufacture human insulin; what warnings they gave to those taking the insulin; whether these were approved by the Committee on Safety of Medicines; and whether the warnings have been changed.
§ Mr. MellorProduct licences for human insulin are held by:
- The Wellcome Foundation
- Lilly Industries
- Fisons Ltd.
- Nordisk UK Ltd.
- Novo Laboratories Ltd.
- Novo Industries
Patient information leaflets for human insulin give a range of warnings covering such subjects as pregnancy, illness, taking other medicines, taking physical exercise and drinking alcohol. All patient information leaflets are approved by the licensing authority. All manufacturers of human insulin agreed to include an additional warning that a few patients who experienced hypoglycaemic reactions after transfer to human insulin have reported that the early warning symptoms were less pronounced or different from those experienced with their previous insulin.