The regulator sounded the alarm after reviewing reports of anticoagulant- associated kidney damage.
Rare but serious renal complications have prompted a TGA warning on oral anticoagulants.
The decision comes after the Advisory Committee on Medicines review of anticoagulant-related nephropathy cases found instances of serious kidney damage in those taking oral anticoagulants overseas, prompting the TGA to take action.
The new warnings have been applied to the four oral anticoagulants available in Australia: apixaban (Eliquis, BMS), dabigatran (Pradaxa, Boehringer Ingelheim), rivaroxaban (Xarelto, Bayer Australia) and warfarin (Coumadin, Marevan, Aspen Pharmaceuticals).
As with all anticoagulants, there is an associated bleeding risk. However, the added warning introduces new, specific recommendations for renal bleeding:
“In patients with altered glomerular integrity or with a history of kidney disease, acute kidney injury may occur, possibly in relation to episodes of excessive anticoagulation and haematuria. A few cases have been reported in patients with no pre-existing kidney disease,” the new warning reads.
Indications for anticoagulant use range from prevention of venous thrombosis, stroke, emboli and clots following surgery to acute limb ischemia in patients with coronary artery disease.
A Medicines Safety Update has also been issued for practitioners, stating that “close monitoring including renal function evaluation is advised in patients with excessive anticoagulation, compromised renal function and haematuria (including microscopic).”
The update also reiterated the importance of raising awareness of the condition to ensure early diagnosis, as renal bleeding can be misdiagnosed as acute kidney injury because of similar symptoms.
Patients are encouraged to look out for symptoms that may indicate kidney dysfunction, such as high blood pressure, decreased urination, blood in urine and swelling around the legs, ankles and eyes.
For the time being, TGA have held off on adding a similar warning to parenteral anticoagulants, deciding that it was “not needed at this stage […] because they are used for much shorter periods of time and often only when people are in hospital”.
