Issue: March 2011
March 01, 2011
1 min read

FDA: Insulin glargine, cancer risk still under review

Evidence ‘inconclusive’ to link insulin glargine to cancer at this time.

Issue: March 2011
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The FDA released a statement today updating the public about its ongoing safety review of insulin glargine use and a possible increased risk for cancer.

The agency said it has reviewed four previously published observational studies that linked insulin glargine (Lantus, Sanofi-Aventis) with an increased risk for cancer, and has determined that the evidence presented in these studies is inconclusive. The FDA cited limitations in study design, methods and data available for analysis.

“These limitations prevent our ability to attribute the observed cancer risk to Lantus,” agency officials said in the statement.

The FDA issued an early communication about the safety of insulin glargine in July 2009, and informed the public about its review of the published data.

As the review is ongoing, including analysis of data from a current clinical trial, the FDA said it will update the public when additional information is available. Meantime, health care professionals are encouraged to continue to follow recommendations on the insulin glargine drug label and discuss any concerns about use with patients.

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