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  • FDA Date: 01/12/2011

    Lantus (insulin glargine) FDA Drug Safety Communication

    Update to Ongoing Safety Review of Lantus (insulin glargine) and Possible Risk of Cancer

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    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. 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.

    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.

    At this time, FDA has not concluded that Lantus increases the risk of cancer. Our review is ongoing, including review of information from a current clinical trial, and the Agency will update the public when it has additional information.

    - Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Lantus.

    - Patients should continue taking Lantus unless told otherwise by their healthcare professional.

    This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs.

    View the full FDA Drug Safety Communication on FDA.gov