BioCentury
ARTICLE | Clinical News

EMA also investigating pancreatic toxicity of antidiabetics

March 27, 2013 12:34 AM UTC

EMA said on Tuesday that it is evaluating the potential pancreatic toxicity of glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors. The announcement comes just days after FDA said it was evaluating the potential pancreatic toxicity of antidiabetics. Both agencies are investigating data published on Friday showing that Type II diabetes therapies may be associated with an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia (see BioCentury Extra, March 14).

EMA noted that the European labels for all GLP-1- and DPP-4-based treatments include warnings of pancreatitis. The agency said the risk management plans for the products also instruct marketing authorization holders to "closely monitor for adverse effects on the pancreas." ...