其 他 安 全 警 示
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| Australia: Oral anticoagulants can cause serious kidney damage in rare circumstances (English only) |
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Therapeutic Goods Administration (TGA) announces that a warning about anticoagulant-related nephropathy (ARN) has been added to the Product Information (PI) for all oral anticoagulants. There are 4 oral anticoagulants available in Australia: apixaban (Eliquis), dabigatran (Pradaxa), rivaroxaban (Xarelto) and warfarin (Coumadin, Marevan).
This is a rare but serious adverse event resulting from profuse glomerular bleeding. It has the potential to cause irreversible kidney damage and death. Although rare, ARN is likely to be underdiagnosed as a cause of acute kidney injury. Early detection and intervention of ARN is critical to minimising its associated morbidity and mortality. Therefore, awareness of this adverse event among health professionals is important.
There have been reports of ARN in patients taking oral anticoagulants, mainly from overseas. TGA investigated this safety signal. TGA also 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 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. The ACM highlighted that ARN is a rare, but serious event that is likely underdiagnosed and requires prescriber education around its presentation (as acute kidney injury) and management. Additionally, the ACM advised that the term ‘anticoagulant-related nephropathy’ should be included in the PI as an adverse event, distinct from ‘haematuria or genitourinary haemorrhage’ and ‘acute kidney injury’.
The ACM do not consider a warning for parenteral anticoagulants is needed at this stage. This is because they are mainly used in hospitals and for a shorter duration.
It is important that health professionals are aware of this side effect, as early detection and treatment is critical to reducing permanent kidney damage and death. Although ARN is rare, it is likely underdiagnosed. This is 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.
If health professionals are treating patients taking oral anticoagulants, talk to them about the risk of ARN. Close monitoring, including renal testing, is recommended for those with excessive anticoagulation (or supratherapeutic INR for those on warfarin) and haematuria. Monitoring is also recommended for patients with compromised renal function who are taking apixaban, dabigatran or rivaroxaban. Be aware that ARN has been reported in patients who do not have pre-existing kidney disease.
As of 24 Apr 2023, one case of ARN had been reported to the TGA, where the sole suspect was warfarin. The patient was taking concomitant amoxicillin. The case describes resolution of the adverse event one month after warfarin was stopped.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/oral-anticoagulants-can-cause-serious-kidney-damage-rare-circumstances
In Hong Kong, there are registered pharmaceutical products which are oral anticoagulants containing apixaban (4 products), dabigatran (3 products), edoxaban (3 products), rivaroxaban (11 products) and warfarin (4 products). All products are prescription-only medicines.
So far, the Department of Health (DH) has received adverse drug reaction related to apixaban (60 cases; of which one case was related to kidney disorder and one case was related to renal function abnormal), dabigatran (20 cases; of which one case was related to acute kidney injury with haematuria), edoxaban (29 cases), rivaroxaban (26 cases) and warfarin (14 cases). For edoxaban, rivaroxaban and warfarin, the adverse drug reactions received were not related to kidney damage.
In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Jun 2, 2023
Issued at HKT 16:00
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