PRAC analyzed pooled data from spontaneous case reports, clinical trials, and the literature regarding the risk of anticoagulant-associated nephropathy in patients receiving warfarin. PRAC has agreed that MAH of drugs containing warfarin should submit a change within 2 months of publication of the PRAC recommendation to change the product information – where applicable, the proposed wording should be adapted to the existing text regarding anticoagulant-related nephropathy.
Relevant MAHs should also provide a literature review of anticoagulant-associated nephropathy with warfarin in the next PSUR, with particular emphasis on potentially increased mortality and decreased renal function as a consequence of anticoagulant-associated nephropathy. The review should consider any new information published about possible risk factors for anticoagulant-associated nephropathy resulting from warfarin treatment.

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