§ Tim LoughtonTo ask the Secretary of State for Health what the proven side effects are of long-term consumption of analogue human insulin. [187054]
§ Ms Rosie WintertonClinical trials submitted at the time of licensing have examined the safety and efficacy of the human insulin analogues (insulin glargine, insulin aspart and insulin lispro) in diabetic patients treated for up to 12 months. Generally, the side effects observed1360W with the human insulin analogues were similar to those seen with existing human insulins, with the most commonly observed side effects being hypoglycaemia, visual disturbance and injection reactions.
The longer term safety of the use of human insulin analogues in routine clinical practice is closely monitored by the Medicines and Healthcare products Regulatory Agency. Any possible new safety issue to emerge is evaluated and, if necessary, product information for prescribers and patients is updated.
Full guidance on prescribing and use of human insulin analogues, including possible side effects is provided in the summary of product characteristics (the product information for prescribers) and the patient information leaflet. Key prescribing information is also included in the British National Formulary, which is made available by the Department to doctors and pharmacists.