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European drugs agency clashes with scientists over safety of GLP-1 drugs

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f4838 (Published 30 July 2013) Cite this as: BMJ 2013;347:f4838
  1. Deborah Cohen
  1. 1BMJ

Despite concerns raised by some scientists that a particular class of antidiabetes drugs known as glucagon-like peptide-1 (GLP-1) based drugs may have adverse effects on the pancreas, the European Medicines Agency has said that it had no new concerns about the drugs on the basis of the “presently available data.”

These drugs, which are also called incretin mimetics, are of two types: GLP-1 agonists, such as exenatide, liraglutide, and lixisenatide; and dipeptidyl peptidase-4 (DPP-4) inhibitors, such as sitagliptin and saxagliptin.

A recent BMJ investigation found evidence indicating a potential risk of unwanted effects of the GLP-1 based drugs on the pancreas.1 This evidence included unpublished evidence of increases in size and abnormal changes in animal pancreases, raised pancreatic enzyme concentrations in humans, and pancreatitis in early clinical trials.

The investigation also highlighted safety signals for pancreatic cancer from the adverse reporting database from three different agencies.

However, after its own investigation of “presently available” non-clinical and clinical data, the European drug regulator said that the evidence did “not confirm recent concerns over an increased risk of pancreatic adverse …

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