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FDA is investigating the possibility that Lantus (insulin glargine) may be associated with an increased risk of cancer. Three of four observational studies published recently in the journal Diabetologia suggested an increased cancer risk associated with Lantus. All of the studies had drawbacks or inconsistencies that preclude drawing any firm conclusions about whether the drug is actually associated with an increased risk of cancer. FDA is reviewing many sources of safety data for Lantus, including these four newly published studies, to better understand whether this drug poses a cancer risk. The agency is also deciding whether any additional safety studies will be needed. FDA will keep practitioners and patients informed as new information becomes available. In the meantime, FDA is cautioning patients not to stop taking their insulin without consulting a physician, since uncontrolled blood sugar levels can have serious immediate and long-term effects.