MHLW (Japan) orders label revisions to five anticoagulants to advise the risk of kidney injury

The Ministry of Health, Labor and Welfare (MHLW) on November 21 ordered label revisions for five anticoagulants to newly advise the risk of acute kidney injury, including Bristol Myers Squibb’s Eliquis (apixaban). The four other anticoagulants subject to the label revisions are Daiichi Sankyo’s Lixiana (edoxaban), Nippon Boehringer Ingelheim’s Prazaxa (dabigatran), Bayer Yakuhin’s Xarelto (rivaroxaban), and warfarin (Eisai’s Warfarin, etc.)

For their labels, acute kidney injury will be added to the clinically significant adverse reactions section. A total of 52 cases involving acute kidney injury including anticoagulant-related nephropathy have been reported for the five APIs. For four APIs excluding Eliquis, there were 18 cases for which a causal relationship with the drugs was reasonably possible. For four APIs excluding warfarin, a total of eight deaths were reported following their use, but a causal link could not be established for any of them.