Published: 15 January 2024
Updated: 13 July 2024
Safety Information
Monitoring communication
DPP-4 inhibitors and the possible risk of ileus
Update to original communication
9 July 2024
During the monitoring period (15 January 2024 to 15 June 2024), Medsafe and the Centre for Adverse Reactions Monitoring (CARM) did not receive any case reports of intestinal obstruction, including ileus, associated with a DPP-4 inhibitor. At this stage, no further action is required regarding DPP-4 inhibitors and the risk of intestinal obstruction, including ileus.
The benefit-risk balance for DPP-4 inhibitors remains positive when used for the approved indications.
Original communication
15 January 2024
Monitoring closes 15 June 2024
The Medicines Adverse Reactions Committee (MARC) discussed, at its 195th meeting, whether dipeptidyl peptidase-4 (DPP-4) inhibitors, such as vildagliptin and saxagliptin, may cause ileus.
The MARC considered that there was currently insufficient evidence of a causal link between use of DPP-4 inhibitors and ileus. The MARC recommended that Medsafe publish a monitoring communication to gain further information on this topic.
The aim of this communication is to encourage reporting of any cases where ileus may have been associated with use of a DPP-4 inhibitor.
Products affected
More information
Medsafe's actions
Reporting adverse events
Products affected
| Product name | Sponsor |
|---|---|
| Galvus | Novartis New Zealand Ltd |
| Galvumet | Novartis New Zealand Ltd |
These medicines, together with diet and exercise, are indicated to improve
glycaemic control in patients with type 2 diabetes.
More information
At their 195th meeting, the MARC considered whether the available evidence supports a causal link between DPP-4 inhibitors and intestinal obstruction, including ileus.
The association may have biological plausibility as DPP-4 inhibitors act by inhibiting the breakdown of endogenous glucagon-like peptide-1 (GLP-1), which has a role in inhibition of gastrointestinal motility.
The MARC considered the results of a population-based cohort study by Faillie et al, which found a higher risk of intestinal obstruction among people starting a DPP-4 inhibitor compared to those starting a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or a GLP-1 receptor agonist.1 The MARC considered that the limitations of the study meant that the results should be interpreted with caution.
The MARC recommended that Medsafe publish a monitoring communication to gather more information about a possible association between DPP-4 inhibitors and intestinal obstruction, including ileus.
See the minutes of the MARC meeting and the report presented to the MARC for further details:
- Minutes of the 195th MARC meeting
- Report: DPP-4 inhibitors and GLP-1 receptor agonists and the risk of intestinal obstruction (PDF 639KB, 33 pages)
See the consumer medicine information (CMI) and data sheet for advice on how to take DPP-4 inhibitor medicines and the known side effects.
Search for consumer medicine information and data sheets
Medsafe’s actions
We are placing this safety concern on the Medicines Monitoring ()
scheme to encourage reporting of ileus observed with DPP-4 inhibitors.
Reporting adverse events
Please report adverse events to medicines (side effects) to the Centre for Adverse Reactions Monitoring (CARM). Anyone can submit a report to CARM.
References
Faillie J-L, Yin H, Yu OH, et al. 2022. Incretin‐based drugs and risk of intestinal obstruction among patients with type 2 diabetes. Clinical Pharmacology & Therapeutics 111(1): 272–82. DOI: 10.1002/cpt.2430 (accessed 19 June 2023).
