Mr. Dunne: To ask the Secretary of State for Health how many fatalities of diabetes patients there have been since January 2004 where the long-acting insulin analogue, Lantus, has been suspected to be a cause or contributory factor; and what steps have been taken to assess its safety. [56921]
Jane Kennedy: Clinical trials submitted at the time of licensing have examined the safety and efficacy of the Lantus (insulin glargine) in diabetic patients treated for up to 12 months. Generally, the side effects observed with Lantus were similar to those seen with human insulins, with the most commonly observed side effects being hypoglycaemia, visual disturbance and injection site reactions.
The Medicines and Healthcare products Regulatory Agency (MHRA) receives reports of suspected adverse drug reactions (ADRs) via the United Kingdom yellow card scheme. A total of 229 reports of suspected ADRs have been received in association with Lantus since January 2004 and of these, 12 had a fatal outcome. Where cause of death was reported there is no particular pattern. It is important to appreciate that the reporting of a reaction does not necessarily mean it was caused by the drug and may relate to other factors such as underlying illnesses or other medicines taken concurrently.
The longer term safety of the use of human insulin analogues, including Lantus, in routine clinical practice is closely monitored by the MHRA. Any possible new safety issue to emerge is evaluated and, if necessary appropriate action will be taken and the product information for prescribers and patients updated.
