At this time, the FDA has concluded that Lantus (insulin glargine [recombinant], from sanofi-aventis) does not increase the risk of cancer. Since July 2009, the FDA has reviewed clinical trial data and determined that the evidence presented in the studies are inconclusive, due to limitations in how the studies were designed and carried out and in the data available for analysis. These limitations prevent ability to attribute the observed cancer risk to Lantus.
The FDA will continue to review data as it becomes available and provide updates. Healthcare professionals should continue to follow the recommendations on the drug label.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm.