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FDA Updates Safety Review of Diabetes Drug for Possible Cancer Risk

Posted Jan 25 2011 12:00am

FDA Updates Safety Review of Diabetes Drug for Possible Cancer Risk

Earlier this month, the FDA said there was "inconclusive" evidence to suggest that the common diabetes drug glargine (Lantus) increases cancer risk. This was an update to a safety review the agency initiated in July 2009, after results from four observational studies suggested that users of the drug, a modified form of human insulin, had an increased cancer risk. The FDA noted that firm conclusions about the association cannot be reached at this time, “due to limitations in how the studies were designed and carried out and in the data available for analysis.”

The studies were all published online September 2009 in the journal Diabetologia; none was conducted in the United States. The FDA noted that three of the four studies showed an association between glargine use and cancer risk.

In addition, the FDA reviewed data from a randomized clinical trial of glargine in patients with type 2 diabetes and found no evidence of increased cancer risk. “However, the study was not designed or powered to evaluate cancer outcomes and these outcomes were not verified in medical records or reviewed by cancer experts,” the agency noted.

The safety review is ongoing and also includes an ongoing clinical trial called ORIGIN . An interim analysis of that trial suggested no increased risk of cancer associated with glargine, the agency explained.


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