Published: 31 January 2018
Safety Information
Monitoring Communication
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:
- Prevention of stroke and systemic embolism.
- Prevention of venous thromboembolism (VTE).
- Treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
- Prevention of recurrent DVT and/or PE.
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 ()
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
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
Update Information
During the
period (31 January to 31 July 2018), seven cases of gout or gout aggravation
and one of pseudogout (chondrocalcinosis) were reported to the Centre for
Adverse Reactions Monitoring (CARM). Two of the patients were female and
six were male, and the mean age was 70 years. Of the seven patients with
gout, two had a history of gout while the other patients either did not
have a gout history or the history was uncertain. The onset of gout or gout
like symptoms was within 10 weeks after starting treatment with dabigatran
for five patients while it was up to over a year for the other patients.
Cases have also been identified in other countries. Six new reports were added to VigiBase during the monitoring period of which three are from New Zealand.
Review of this safety concern highlighted that other conditions experienced by the patients may increase the risk for developing gout, common risk factors such as atrial fibrilation and difference in methods used to diagnose gout. As gout is a disease that is characterised by flares, it is difficult to pin point the cause of development of the disease as well as reasons for improvement.
This topic was discussed at the 175th meeting of the Medicines Adverse Reactions Committee (MARC). The committee concluded that there is insufficient data to confirm that dabigatran is associated with gout. The MARC minutes are published on the Medsafe website: www.medsafe.govt.nz/profs/MARC/Minutes.asp.
Medsafe will continue to monitor this issue through routine pharmacovigilance. The balance of benefits and risks of harm for dabigatran remains positive and no further action is required at this time.
