Published: 8 August 2024

Safety Information

Monitoring communication

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.

Direct acting oral anticoagulants and potential for patients to experience mood changes (monitoring closes February 2025)

8 August 2024

Monitoring closes February 2025

Medsafe is reviewing the risk of mood changes in individuals taking direct acting oral anticoagulant medicines. The aim of this communication is to encourage further reporting and obtain more information on this potential safety signal.

This communication was stimulated by a report (NZ-Medsafe-153192) received by the Centre for Adverse Reactions Monitoring (CARM) and Medsafe. The report concerns an elderly male who experienced anxiety, irritability and personality change after starting rivaroxaban.

Products affected
More information
Medsafe's actions
Reporting adverse events

Products affected

Product name	Sponsor
Eliquis (apixaban)	Pfizer New Zealand Limited
Pradaxa (dabigatran)	Boehringer Ingelheim (NZ) Ltd
Xarelto (rivaroxaban)	Bayer New Zealand Limited

The products in the table belong to a group of medicines called anticoagulants and are referred to as ‘blood thinners’. They are prescribed to treat and/or prevent blood clots.^1–3

More information

Mood changes including worsening mood, are associated with a number of medicines. Symptoms include low mood, depression, anxiety and behavioural changes (irritability, agitation, confusion, aggression, hostility, paranoia, hallucinations and euphoria). Changes in mood vary depending on the individual and the medicine.⁴

CARM have received a small number of other reports of psychiatric changes associated with rivaroxaban use. Although this potential safety concern was identified with rivaroxaban, we also encourage reporting of mood disorders with other direct acting oral anticoagulants.

See the consumer medicine information (CMI) and data sheet for advice on how to take these 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 mood changes with direct acting oral anticoagulants.

Reporting adverse events

Please report adverse events to medicines (side effects) to CARM. Anyone can submit a report.

References

1. Bayer New Zealand Limited. 2024. Xarelto New Zealand Data Sheet 2 April 2024. URL: www.medsafe.govt.nz/profs/datasheet/x/Xareltotab.pdf (accessed 5 July 2024).
2. Boehringer Ingelheim NZ Limited. 2024. Pradaxa New Zealand Data Sheet 15 March 2024. URL: www.medsafe.govt.nz/profs/Datasheet/p/Pradaxacap.pdf (accessed 5 June 2024).
3. Pfizer New Zealand Limited. 2024. Eliquis New Zealand Data Sheet 20 February 2024. URL: www.medsafe.govt.nz/profs/Datasheet/e/eliquistab.pdf (accessed 5 June 2024).
4. Healthify He Puna Waiora. 2024. Medicines that affect mood 21 March 2024. URL: healthify.nz/medicines-a-z/m/medicines-that-affect-mood/ (accessed 22 July 2024).