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Anticoagulant medicines
Anticoagulants, sometimes called blood thinners, reduce the blood’s natural ability to clot. Although it is important for our blood to clot to stop bleeding, slowing this clotting process down is beneficial for some medical conditions.
Oral forms of these medicines, which are taken as tablets or capsules, are widely prescribed in Australia. Most people need to take them for a long time.
There are 4 oral anticoagulants available in Australia (brand names are shown in brackets): apixaban (Eliquis), dabigatran (Pradaxa), rivaroxaban (Xarelto) and warfarin (Coumadin, Marevan).
More about this side effect
Oral anticoagulants can cause serious kidney damage. This side effect is called anticoagulant-related nephropathy (ARN) and results from bleeding in the kidneys. Although this side effect is rare, it is serious and can be life-threatening.
What is the TGA doing?
We investigated this safety issue after being notified of reports of ARN, mainly from overseas. We also sought independent expert advice from the Advisory Committee on Medicines (ACM).
Given the wide use of these medicines and the seriousness of this side effect, a warning has been added to the prescribing information for all oral anticoagulants.
We decided a warning for anticoagulants given by injection was not needed at this stage. This is because they are used for much shorter periods of time and often only when people are in hospital.
You can read the ACM's statement on this safety issue for more information.
Information for consumers
If you are taking an oral anticoagulant and have any questions or concerns about your treatment, speak to your doctor. Do not stop taking these medicines without discussing it with your doctor first.
Your doctor may want to monitor you more closely and assess your kidney function if:
- you have had previous kidney problems
- you have signs that your dose may be too high.
Contact your doctor immediately if you experience any of the following signs and symptoms:
- high blood pressure
- decreased amount of urine
- blood in urine
- swelling in legs, ankles, and around the eyes.
These symptoms may indicate your kidneys aren’t working properly.
Information for health professionals
We have published a Medicine Safety Update article for health professionals that has more details of our review of this safety issue.
Early detection and treatment of this adverse event is critical to reducing permanent kidney damage and death. Although ARN appears to be rare, it is likely underdiagnosed as a cause of acute kidney damage.
ARN has been reported in patients who do not have pre-existing kidney disease.
If you are treating patients taking oral anticoagulants, talk to them about the risk of this side effect. Close monitoring, including kidney function tests, is recommended for those with excessive anticoagulation, previous kidney problems or blood in their urine.
Where to find more safety information
The prescribing information (Product Information or PI) and educational material for patients (Consumer Medicines Information or CMI) for these medicines have been updated. They now include this new warning. Click through to the current PI and CMI documents for these medicines below:
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine