Editorials

GLP-1 based agents and acute pancreatitis

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1263 (Published 27 February 2013) Cite this as: BMJ 2013;346:f1263
  1. Edwin A M Gale, emeritus professor of diabetic medicine
  1. 1Department of Diabetes and Metabolism, Southmead Hospital, Bristol BS10 5NB, UK
  1. Edwin.Gale{at}bristol.ac.uk

Drug safety falls victim to the three monkey paradigm

Investment companies knew that the Food and Drug Administration safety database carried a signal for acute pancreatitis with the antidiabetic drug exenatide (a glucagon-like peptide 1 (GLP-1) agonist) in 2006, a year before the agency alerted doctors1—a curious reflection on the way we mix business with medicine. The signal had reached astronomical dimensions (more than 10 times that in control drugs) by 2011 and has accelerated since.2 Furthermore, all GLP-1 based agents that have been on the market for more than two years have also generated a signal for acute pancreatitis, suggesting a class effect.

The regulators asked companies to provide more data, and companies have responded with studies showing that acute pancreatitis is more common in diabetes than previously thought and that clear evidence of an increased risk of pancreatitis with GLP-1 based treatments is lacking.3 Warnings on the label notwithstanding, the industry has been able to maintain that the problem does not exist—and has a huge incentive to do so.

This is no …

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