GLP-1 based agents and acute pancreatitis
- 27 February 2013
- Vol. 346 (feb27 1), f1263
- https://doi.org/10.1136/bmj.f1263
Abstract
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 …Keywords
This publication has 7 references indexed in Scilit:
- Elevated Amylase and Lipase Levels in Patients Using Glucagonlike Peptide-1 Receptor Agonists or Dipeptidyl-Peptidase-4 Inhibitors In the Outpatient SettingEndocrine Practice, 2012
- GLP-1–Based Therapies: The Dilemma of UncertaintyGastroenterology, 2011
- Pancreatitis, Pancreatic, and Thyroid Cancer With Glucagon-Like Peptide-1–Based TherapiesGastroenterology, 2011
- A cohort study of acute pancreatitis in relation to exenatide useDiabetes, Obesity and Metabolism, 2011
- GLP-1–Based Therapy for Diabetes: What You Do Not Know Can Hurt YouDiabetes Care, 2010
- Collateral damage: the conundrum of drug safetyDiabetologia, 2009
- Glucagon-Like Peptide-1 Induces Cell Proliferation and Pancreatic-Duodenum Homeobox-1 Expression and Increases Endocrine Cell Mass in the Pancreas of Old, Glucose-Intolerant RatsEndocrinology, 2000