We are watching to see whether the FDA and/or European drug regulators require a Pradaxa liver injury label change adding a new warning about an increased risk of acute liver failure and drug-induced hepatitis — like what was done in Japan last year and is being done now in Canada.
In May 2018 Health Canada announced that their Pradaxa drug safety review evaluating the risk of liver injury associated with Pradaxa concluded that there may be a link. Accordingly, Health Canada is working with the responsible pharmaceutical company to update the Canadian product monograph, or drug label, for Pradaxa (dabigatran) to inform healthcare professionals and patients about this increased risk of liver injury.
In more detail, from this Health Canada document, “Summary Safety Review – PRADAXA (dabigatran etexilate) – Assessing the potential risk of liver injury”:
Safety Review Findings
- At the time of the review, Health Canada had received 27 Canadian reports of severe liver injury related to the use of Pradaxa. Of these reports, 4 were further assessed as they were suspected to be linked to the use of Pradaxa. 3 of the 4 reports, including 1 death, showed a possible link between liver injury and the use of Pradaxa. [footnote omitted]
- This review also looked at 105 international reports of severe liver injury related to the use of Pradaxa. Of these reports, 16 were further assessed as they were suspected to be linked to the use of Pradaxa. 13 of these 16 reports, including 2 deaths, showed a possible link between liver injury and the use of Pradaxa.
That relatively recent Health Canada Pradaxa Safety Review document goes on to point out: “The Pharmaceuticals and Medical Devices Agency of Japan issued a risk communication and updated the product label on September 12, 2017 to include liver injury (i.e. ‘acute hepatic failure, hepatic function disorder, and jaundice’).” [footnote omitted].
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