Safety Information

Published: 31 January 2018

Early Warning System - 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 health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M² logo Dabigatran and gout or gout-like symptoms

31 January 2018

Monitoring finishes 31 July 2018.

Medsafe is highlighting a possible risk of gout or gout-like symptoms with the use of dabigatran.

In September 2017 a report of aggravation of gout after starting treatment with dabigatran was received by the Centre for Adverse Reactions Monitoring (CARM). The patient experienced a marked increase in episodes of gout after starting dabigatran and improved after treatment with dabigatran was stopped, without other intervention.

Review of World Health Organization (WHO) data shows that gout is reported with dabigatran more often than expected.

Products Affected

Product name Sponsor
Pradaxa Boehringer Ingelheim


Pradaxa is used in a variety of conditions including:

Additional Information

Gout is not a known side effect of dabigatran and is not included as a side effect in the data sheet. A search of the WHO’s pharmacovigilance database VigiBase to date, revealed 71 reports worldwide of gout or gout-like symptoms, suspected to be associated with dabigatran use1. This is a higher number than expected, making this association a safety signal. As always these are reports of a suspected link between dabigatran and gout and it is likely that other factors are also involved. This is why we are seeking more information.

Patients who experience significant and/or worsening gout or gout-like symptoms should continue to take their medicine and seek medical advice.

The overall benefit-risk balance of dabigatran remains positive.

Advice on how to take this medicine and the known side effects can be found in the consumer medicine information (CMI) and data sheet.

Search for consumer medicine information and data sheets

Regulator Actions

Medsafe is placing this safety concern on the medicines monitoring (M² logo) scheme to obtain further information on these possible adverse reactions. Please report any cases of gout or gout-like symptoms in patients taking dabigatran. Please include information on the time to onset, whether treatment of gout/gout-like symptoms was required, details on the patient’s renal function and any concomitant medicines with dates of administration if known.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to CARM.

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

References

  1. http://www.vigiaccess.org/