Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer 01-13-2011
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.
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