Published: 15 January 2024

Safety Information

Monitoring communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your healthcare professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

DPP-4 inhibitors and the possible risk of ileus

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 195^th 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 195^th 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).