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No Compelling Evidence Linking Incretin Therapies, Pancreatic Cancer

Mar 6, 2014

U.S. and European regulators have found no compelling evidence of a link between the drug class which includes GLP-1 analogs and DPP-4 inhibitors, and pancreas problems or pancreatic cancer…. 

The U.S. Food and Drug Administration (FDA) and its European counterpart started reviews last year of the medications, which came on the market less than a decade ago, after a study suggested a safety concern.

The drugs in question help spur insulin production after meals. Nine are approved in Europe and seven in the U.S., including include Merck’s Januvia and Janumet, Novo Nordisk’s Victoza and Bristol-Myers Squibb’s Byetta and Bydureon.

A study of insurance records had suggested that the incretin-based drugs could double this risk.

In July, the European Medicines Agency said its review had found no new evidence of pancreas problems.

Last Wednesday, the New England Journal of Medicine published a report from scientists in Europe and at the FDA saying reviews of animal and human studies, plus new studies commissioned to look at this risk, had found no treatment-related adverse effects on the pancreas.

Although the review ”provides reassurance,” the agencies ”have not reached a final conclusion” about whether the drugs can cause pancreas problems and will ”continue to investigate this safety signal,” the authors write. Meanwhile, the drugs’ labels appear adequate, the agencies conclude.

NEJM, March 2014