Drug Safety and Availability FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer

FDA PRESS RELEASE
-Drugs@FDA Data Files


The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. Lantus is a long-acting modified version of human insulin (insulin analog) used to control blood sugar in patients with Type 1 and Type 2 diabetes.

In July 2009, FDA issued an Early Communication About Safety of Lantus (insulin glargine) to inform the public that it was reviewing four published observational studies, three of which suggested an increased risk of cancer associated with the use of Lantus.1-4 FDA has reviewed the four studies and has determined that the evidence presented in the studies is inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis. These limitations prevent our ability to attribute the observed cancer risk to Lantus (see Data Summary below).

FDA has also reviewed results from a five-year randomized clinical trial, Evaluation of Diabetic Retinopathy Progression in Subjects with Type 2 Diabetes Mellitus Treated with Oral Agents Plus Insulin, which compared Lantus to Neutral Protamine Hagedorn (NPH) insulin in individuals with Type 2 diabetes. The results did not show an increased risk of cancer in subjects treated with Lantus compared to those treated with NPH insulin; however, this study was not specifically designed to evaluate cancer outcomes.

FDA is continuing to work with the manufacturer of Lantus and the U.S. Department of Veterans Affairs (VA) to further evaluate the long-term risk, if any, for cancer associated with the use of Lantus.

For more information, please visit: Lantus
Drug Safety and Availability FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer