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.

Possible risk of vasculitis with vildagliptin products (Galvus, Galvumet)

Update to original communication

During the monitoring period (22 February 2022 to 22 August 2022), the Centre for Adverse Reactions Monitoring (CARM) did not receive any further reports of vasculitis with vildagliptin.

However, the company has decided to update the vildagliptin data sheets to include vasculitis as an adverse drug reaction.

The balance of benefits and risks of harm for vildagliptin remains positive and no further action is required at this time.

Original communication

22 February 2022

Medsafe is highlighting a possible risk of vasculitis with the use of vildagliptin. The aim is to encourage further reports and increase the information on this potential safety signal.

This potential safety signal was triggered by a report received by the Centre for Adverse Reactions Monitoring (CARM). The report (CARM ID number 138311) describes a 68-year-old male patient who developed a vasculitic rash approximately ten days after starting treatment with three medicines, including vildagliptin. Leukocytoclastic vasculitis was confirmed. The patient was reported to have recovered.

Products affected
Additional information
Regulator actions
Reporting
References

Products affected

Product name	Sponsor
Galvus	Novartis New Zealand
Galvumet	Novartis New Zealand

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus.^1,2

Additional information

Vasculitis is a broad term meaning inflammation of blood vessels.³There are many different types of vasculitis, varying in severity, and these are grouped based on the size of the blood vessels that are affected.³

Drug-induced vasculitis most frequently affects the skin and involves small or medium-sized blood vessels.⁴ See DermNet NZ for more information. Systemic symptoms may accompany the skin lesions.^3,5 Other organs and tissues may be affected, particularly kidneys and lungs.^3,5

Currently, vasculitis is not a listed reaction in the Galvus and Galvumet data sheets. Medsafe has published this monitoring communication to encourage health care professionals and consumers to report further cases of vasculitis associated with vildagliptin use. We will continue to monitor this potential safety signal and will produce updated advice for health care professionals and consumers as necessary.

See the vildagliptin Consumer Medicine Information (CMI) and data sheets for advice on how to take these medicines and their known side effects:

Search for consumer medicine information and data sheets

Regulator actions

Medsafe is placing this potential safety signal on the Medicines Monitoring () scheme to encourage reporting of vasculitis with vildagliptin products.

Reporting

Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).

Medsafe cannot give advice about an individual’s medical condition. If you have concerns about a medicine you are taking, please talk to your health care professional.

References

Novartis New Zealand Limited. 2020. Galvus New Zealand Data Sheet 1 July 2020. URL: medsafe.govt.nz/profs/Datasheet/g/galvustab.pdf (accessed 8 December 2021).
Novartis New Zealand Limited. 2020. Galvumet New Zealand Data Sheet 2 September 2020. URL: medsafe.govt.nz/profs/Datasheet/g/galvusmettab.pdf (accessed 8 December 2021).
Merkel PA. 2021. Patient education: Vasculitis (Beyond the Basics). In: UpToDate 26 February 2021. URL: uptodate.com/contents/vasculitis-beyond-the-basics (accessed 14 December 2021).
Fett N. 2020. Evaluation of adults with cutaneous lesions of vasculitis. In: UpToDate 23 June 2020. URL: uptodate.com/contents/evaluation-of-adults-with-cutaneous-lesions-of-vasculitis (accessed 14 December 2020).
Australasian Society of Clinical Immunology and Allergy. 2019. Vasculitis Disorders URL:allergy.org.au/patients/autoimmunity/vasculitis-disorders (accessed 14 December 2021).