Acute Pancreatitis with Liraglutide – Conclusion
An analysis of MedWatch adverse event reports submitted to the Food and Drug Administration in the first two years following approval
June 5, 2014
- Cover Letter to the FDA (pdf)
- Full Report (pdf)
- View the Press Release
- June 17, 2014 – FDA Response
- Executive Summary
- Part 1: Background
- Part 2: Methods
- Part 3: Results
- Part 4: Discussion
- Part 5: Conclusion
- Acknowledgements
- Appendix: Charts & Graphs
PART V: CONCLUSION
A relatively large number of cases of acute pancreatitis with liraglutide therapy were reported to the FDA’s AERS during the first two years following its approval. Applying the Naranjo causality criteria to these reports showed that liraglutide was a “probable” cause of 51 cases of acute pancreatitis as well as a “definite” cause of one case, the latter being the first documented report of a positive rechallenge. These findings suggest a causal link between liraglutide and the occurrence of acute pancreatitis. Considered together with results from studies of other incretin mimetics, it appears that this class of drugs increases the risk of acute pancreatitis in patients with diabetes, a population already at an increased risk for the condition.
Next Page » Part VI: Acknowledgements