No Cancer Risk With Insulin Glargine, Says EMA


May 31, 2013

The European Medicines Agency (EMA) has concluded that insulin-glargine–containing medicines (Lantus, Optisulin, Sanofi) for diabetes do not show an increased risk of cancer, so the balance of the medicine’s benefits and risks remains unchanged.

Concern arose after the publication of 4 registry studies some years ago, which highlighted a potential link between insulin-glargine products, which are long-acting, and malignancies, particularly breast cancer. However, in July 2009, the EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that some limitations in the way these studies were conducted meant a link between insulin glargine and cancer could not be confirmed or excluded from the results.

The CHMP therefore requested that Sanofi provide further data; the company subsequently carried out further studies and submitted the results to the CHMP for review.

The new data include results from 2 cohort studies. The first collected information from around 175,000 patients in northern Europe treated with insulin glargine, human insulin, or combined insulin, while the other obtained data from approximately 140,000 patients in the United States. Both looked at the occurrence of breast, colorectal, and prostate cancer with various insulins.

Also included in the review were results from a case-control study conducted in Canada, France, and the United Kingdom, comparing 775 patients with diabetes who had breast cancer with a control group of patients who had diabetes but did not have breast cancer, comparing insulin glargine with human insulin and other types of insulin.

And a thorough search of studies in the scientific literature was performed, and data from these were considered, too, the EMA notes.

"Based on the assessment of the population-based studies, the CHMP concluded that overall the data did not indicate an increased risk of cancer with insulin glargine," says the EMA. It notes also that "there is no known mechanism by which insulin glargine would cause cancer and that a cancer risk has not been seen in laboratory studies."


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