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U.S. Department of Health and Human Services

Safety

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Lantus (insulin glargine)

Audience - Diabetes healthcare professionals, patients

[UPDATED 01/12/2011] FDA has reviewed studies and 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 ability to attribute the observed cancer risk to Lantus.

At this time, FDA has not concluded that Lantus increases the risk of cancer. FDA's 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.
For more information on FDA's review, please refer to the January 12 2011 Drug Safety Communication.

 

[Posted 07/01/2009] FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.

FDA is currently reviewing many sources of safety data for Lantus, including these newly 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 use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.

The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program.

 

[01/12/2011 - Drug Safety Communication - FDA]
[07/01/2009 - Early Communication About Safety of Lantus (insulin glargine) - FDA]