Remains Unknown Whether Pradaxa Label Change About Liver Damage In Canada Will Be Followed By Similar FDA Action In US
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.
- In most reports that were further assessed by Health Canada, other medical conditions and medications could have caused the liver injury.
- This safety review looked at information from 2 published cases of liver injury suspected to be linked to the use of Pradaxa. These 2 cases were not further reviewed because severe liver injury was not confirmed.
- A review of the scientific literature did not find any published studies that showed an increased risk of liver injury in patients treated with Pradaxa.
- Product labels in the United States and the European Union do not contain any information specific to liver injury.
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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].
Here are the two related drug safety documents about Pradaxa issued by Japan's Pharmaceuticals and Medical Devices Agency (PMDA):
We will watch to see whether the FDA and/or European drug regulators require a Pradaxa label change adding a new warning about an increased risk of liver injury, e.g., acute liver failure, abnormal liver function, and jaundice.
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