lantus and cancer

On July 1, the U.S. Food and Drug Administration released an Early Communication regarding the safety of Lantus (insulin glargine), a manufactured insulin used to treat people with Type 1 and Type 2 diabetes. Four recent studies conducted in Europe indicate an increased risk of cancer for patients treated with Lantus.

According to the FDA communication, the four observational studies evaluated large patient databases and all reported some level of association between the use of insulin glargine, and other insulin products, and various types of cancer.

Similar to human insulin, insulin glargine is used to control blood sugar in people with Type 1 and Type 2 diabetes. Insulin glargine, however, is a modified version of human insulin (an insulin analogue) that allows for the control of blood sugar for extended periods of time (a long-acting insulin). Insulin glargine is approved for once-a-day dosage by subcutaneous injection (injection under the skin).

However, despite the results of the European study, at this time the FDA is recommending that patients taking Lantus do not stop use of the product, as there is concern that uncontrolled blood sugar levels that can result from stopping diabetes treatment can have both immediate and long-term serious adverse effects.

Patients are advised to consult with their health care provider as soon as possible to discuss concerns.

According to the FDA communication, “FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus.

“Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed.”