THE Therapeutic Goods Administration has imposed a new warning on all oral anticoagulants prescribed in Australia, advising of the risk of serious kidney damage from taking the medications.
The advisory applies to a range of items including Xarelto from Bayer, Boehringer Ingelheim's Pradaxa and Eliquis from Bristol-Myers Squibb - as well as generic versions of warfarin under the Marevan and Coumadin brands.
Warning of the risk of anti-coagulant-related nephropathy (ARN) (bleeding in the kidneys), the TGA's advice notes that "although this side-effect is rare, it is serious and can be life-threatening".
All oral forms of the medications have had the warning applied, but not injectable versions because they are generally used for shorter periods and in a hospital setting.
The TGA cited a recent investigation into reports of ARN in patients taking oral anticoagulants, mainly from overseas, undertaken by the Advisory Committee on Medicines (ACM).
The Committee noted that 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 TGA noted.
Health professionals are advised to be aware of the side effect, as early detection and treatment is critical to reducing permanent kidney damage and death.
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