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European Health Regulators Investigate Pancreatic Risks with Diabetes Drugs

May 31, 2013

The European Medicines Agency (EMA), Europe’s top drug regulator, is investigating research findings that suggest there is an increased risk of pancreatitis (inflammation of the pancreas) and precancerous cell changes associated with certain Type 2 diabetes drugs.

The drugs involved are the GLP-1-based therapies (glucagon-like-peptide-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors, also known as incretin mimetics. Incretin mimetic drugs include exenatide (Byetta, Bydureon); liraglutide (Victoza); sitagliptin (Januvia and Janumet); and linagliptin (Tradjenta). These drugs mimic the natural hormones that stimulate the release of insulin in response to a meal and are used to help lower blood sugar in adults with Type 2 diabetes.

The study findings are based on an examination of a small number of pancreatic tissue samples obtained from organ donors—with and without diabetes—who died of causes other than diabetes. In March, the U.S. Food and Drug Administration (FDA) launched a probe of incretin mimetics after the study was published online in the journal Diabetes. The researchers from the University of California, Los Angeles medical school found evidence of pancreatic cell damage in those who had taken incretin mimetics.

The European Medicines Agency said that possible effects on the pancreas were identified when incretin mimetics were being evaluated prior to marketing authorization. Warnings about the risks are included in the product information, the agency said, and risk-management plans for these medicines call for close monitoring for adverse effects.

Independent “pharmacovigilance” centers across the European Union are collecting safety data on diabetes medicines. Neither the EMA nor the FDA has yet concluded what, if any, further regulatory action is necessary and, for now, the EMA said, “health care professionals should continue to prescribe these medicines in accordance with the product information,” according to Law360.

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