Published: 14 November 2019
Updated:  21 May 2020

Safety Information

Monitoring

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.

M2 Possible risk of vasculitis with dabigatran (Pradaxa)

Update Information

21 May 2020

During the monitoring period (14 November 2019 to 14 May 2020), the Centre for Adverse Reactions Monitoring (CARM) did not receive any further reports of vasculitis associated with the use of dabigatran.

Medsafe will continue to monitor this issue through routine pharmacovigilance. The benefit-risk balance for dabigatran remains positive and no further action is required at this time.

Original Communication

14 November 2019

Description of the safety concern

Monitoring finishes 14 May 2020

Medsafe is highlighting a possible risk of vasculitis with the use of dabigatran. 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 127024) describes a 60-year-old male patient who developed a vasculitic rash on both legs approximately one month after starting treatment with dabigatran. He was also taking other long-term medicines. Leukocytoclastic vasculitis was confirmed. After ceasing dabigatran, the rash subsided. The patient was reported to have recovered.

• Product affected
• Additional information
• Regulator actions
• Reporting

Product affected

Product name	Sponsor
Pradaxa	Boehringer Ingelheim (NZ) Ltd

Dabigatran is indicated for the prevention of stroke, systemic embolism, venous thromboembolic events and reduction of vascular mortality and treatment of acute deep vein thrombosis and/or pulmonary embolism [1].

Additional information

At 30 September 2019, four reports describing suspected vasculitis or vasculitic rash with dabigatran use have been reported in New Zealand since 2012.

Vasculitis is a broad term meaning inflammation of blood vessels [2]. There are many different types of vasculitis, varying in severity, and these are grouped based on the size of the blood vessels that are affected [2].

Drug-induced vasculitis most frequently affects the skin and involves small or medium-sized blood vessels [3, 4]. See DermNet NZ for more information. Systemic symptoms may accompany the skin lesions [2, 5]. Other organs and tissues may be affected, particularly kidneys and lungs [2, 5].

Currently, vasculitis is not a listed reaction in the New Zealand data sheet for Pradaxa. Medsafe has published this monitoring communication to encourage health care professionals and consumers to report further cases of vasculitis associated with dabigatran use.

Advice on how to take this medicine and known side effects is available in the Pradaxa Consumer Medicine Information (CMI) and data sheet.

Regulator actions

Medsafe is placing this safety concern on the Medicines Monitoring () scheme to encourage reporting of vasculitis occurring in patients taking dabigatran.

Reporting

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

Medsafe will continue to monitor this issue and will produce updated advice for health care professionals and consumers as necessary.

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

References

1. Boehringer Ingelheim (NZ) Limited. 2019. Pradaxa Data Sheet 15 July 2019. ../../profs/Datasheet/p/Pradaxacap.pdf (8 October 2019).
2. UpToDate. 2019. Patient education: Vasculitis (Beyond the Basics) 21 January 2019. www.uptodate.com/contents/vasculitis-beyond-the-basics (10 October 2019).
3. UpToDate. 2018. Evaluation of adults with cutaneous lesions of vasculitis www.uptodate.com/contents/evaluation-of-adults-with-cutaneous-lesions-of-vasculitis (8 October 2019).
4. Radic M, Martinovic Kaliterna D and Radic J. 2012. Drug-induced vasculitis: a clinical and pathological review. Neth J Med 70(1): 12-7. http://www.ncbi.nlm.nih.gov/pubmed/22271809
5. Australasian Society of Clinical Immunology and Allergy. 2019. Vasculitis Disorders www.allergy.org.au/patients/autoimmunity/vasculitis-disorders (8 October 2019).