The FDA has notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine [recombinant], from Sanofi-aventis) and a possible risk for cancer in patients with diabetes. Three of these studies suggest an increased risk for cancer associated with Lantus therapy. The FDA is currently reviewing safety data for Lantus, including the four 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 Lantus therapy. Discussions between the FDA and Sanofi-aventis are ongoing to determine if additional safety and efficacy studies of Lantus will need to be performed. Based on currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting their healthcare professional.

Lantus is indicated in the treatment of type 1 diabetes (in adults and children) and type 2 diabetes (in adults) when basal (long-acting) insulin is needed.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm.