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TGA issues oral anticoagulants warning


Matt Woodley


6/06/2023 5:18:28 PM

Reports of serious kidney damage in rare circumstances have prompted a class-wide update to the medications’ product information.

Warfarin tablets
One case of anticoagulant-related nephropathy has been reported in Australia, where the sole suspect was warfarin.

A warning about anticoagulant-related nephropathy (ARN) has been added to the Product Information (PI) for all oral anticoagulants, the Therapeutic Goods Administration has advised.
 
ARN, a rare but serious adverse event resulting from profuse glomerular bleeding, has been reported overseas among patients taking anticoagulants and has the potential to cause irreversible kidney damage and death.
 
In making its announcement, the TGA noted that ARN is likely to be underdiagnosed as a cause of acute kidney injury, and that early detection and intervention is critical to minimising its associated morbidity and mortality.
 
‘Awareness of this adverse event among health professionals is important,’ the regulator said. 
 
The TGA went on to state that the warning was released after it investigated the overseas reports and sought expert advice from the Advisory Committee on Medicines (ACM) about mitigating the risk of harm in Australia.
 
‘The ACM noted this adverse event is now well documented in the medical literature with warfarin and there is growing evidence for other oral anticoagulants,’ the release states.
 
‘The ACM supported a class-wide warning being added to the PI for all oral anticoagulants. This is because these medicines are widely used, and this adverse event is serious.’
 
However, despite supporting the change to the medications’ PI, the ACM says a warning for parenteral anticoagulants is not currently needed, as they are mainly used in hospitals and for a shorter duration.
 
Health professionals have been asked to be on alert for the potential of ARN and also to talk to patients taking oral anticoagulants about the risks.
 
‘It is important that you are aware of this side effect, as early detection and treatment is critical to reducing permanent kidney damage and death,’ the TGA release states.
 
‘[ARN] is likely underdiagnosed … because kidney biopsy is required for a definitive diagnosis but is rarely performed in people taking anticoagulants.
 
‘Also, many patients who develop ARN have comorbidities that may explain their acute kidney injury presentation.’
 
Close monitoring, including renal testing, is recommended for patients with excessive anticoagulation (or supratherapeutic INR for those on warfarin) and haematuria. Clinicians have also been told that ARN has been reported in patients who do not have pre-existing kidney disease.
 
Monitoring is also recommended for patients with compromised renal function who are taking apixaban (Eliquis)dabigatran (Pradaxa) or rivaroxaban (Xarelto).
 
As of 24 April 2023, one ARN case had been reported to the TGA, where the sole suspect was warfarin. The patient was taking concomitant amoxicillin, and the adverse event was resolved one month after warfarin was stopped.
 
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anticoagulant-related nephropathy anticoagulants TGA Therapeutic Goods Administration


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