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EMEA investigates Lantus safety claims

Following the recent publicity over questions of safety of insulin analogues, the EMEA is looking into four recently published registry studies

Following the recent publicity over questions of safety of insulin analogues, the European Medicines Agency (EMEA) is looking into four recently published registry studies. The studies investigate a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer and were published on the Diabetologia website on June 26, 2009. 

Insulin glargine is a long-acting insulin analogue, marketed in the EU by sanofi-aventis as Lantus and Optisulin, for the treatment of adults, adolescents and children aged six years or above with diabetes, when treatment with insulin is required. 

The results of four studies submitted to Diabetologia were inconsistent. The first was led by the Institute for Quality and Efficiency in Health Care (IQWiG), using data from a German health insurance database. It suggested a dose dependent link between insulin glargine and malignancies. Swedish researchers then found an association with breast cancer in a group of patients using insulin glargine as monotherapy but not in another group using the drug together with other types of insulin. A paper from the Scottish Diabetes Research Network Epidemiology Group (SDRN) showed a small, non-significant increased risk for breast cancer associated with insulin glargine and researchers from Cardiff and Bristol found no association between cancer and use of the drug.

On the basis of the currently available data, a relationship between insulin glargine and cancer has not been established, but the concerns raised by these studies require in-depth evaluation, state the EMEA.

Sanofi-aventis' chief medical officer, Jean-Pierre Lehner, said: "Given the extensive clinical evidence covering over 70,000 patients and the results of post-marketing surveillance arising from 24 million patient-years of experience, sanofi-aventis stands behind the safety of Lantus. We consider that the results of these patient registries are not conclusive."

The company added that patient safety was a primary concern and that it would monitor the safety of Lantus "in close collaboration with regulatory agencies and scientific experts".

The EMEA's Committee for Medicinal Products for Human Use (CHMP) will perform a detailed assessment of the studies' results and any other relevant information. This review will also address issues, such as dose-response effects, the implications of the relatively short duration of the studies and influence of other factors on the risk of breast cancer and other cancers. 

The EMEA advises patients being treated with insulin glargine to continue treatment as normal, and will provide further information once the CHMP review is complete.

1st July 2009

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