Pradaxa antidote9/5/2023 ![]() The Pharmaceutical and Medical Devices Agency of Japan issued a risk communication Footnote 1 and updated the product label on Septemto include liver injury (i.e. Health Canada will take appropriate and timely action if and when any new health risks are identified. Health Canada will continue to monitor safety information involving Pradaxa, as it does for all health products on the Canadian market, to identify and assess potential harms.Health Canada will be working with the manufacturer to update the safety information for Pradaxa to inform healthcare professionals and patients about the potential for severe liver injury.Health Canada's review found that there may be a link between Pradaxa and liver injury.Product labels in the United States and the European Union do not contain any information specific to liver injury.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.These 2 cases were not further reviewed because severe liver injury was not confirmed. This safety review looked at information from 2 published cases of liver injury suspected to be linked to 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.13 of these 16 reports, including 2 deaths, showed a possible link between liver injury and the use of Pradaxa. Of these reports, 16 were further assessed as they were suspected to be linked to the use of Pradaxa. This review also looked at 105 international reports of severe liver injury related 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. Of these reports, 4 were further assessed as they were suspected to be linked to the use of Pradaxa. At the time of the review, Health Canada had received 27 Canadian reports Footnote a of severe liver injury related to the use of Pradaxa.In 2016, there were approximately 711,000 prescriptions for Pradaxa filled in Canada.Pradaxa is available as capsules taken by mouth. Dabigatran etexilate has been marketed in Canada since 2008 under the brand name Pradax (later renamed to Pradaxa).prevent stroke or sudden blocking of a blood vessel due to potential blood clots in patients with an abnormal heart rhythm (atrial fibrillation).treat blood clots and prevent them from reoccurring in the veins of legs and/or lungs.prevent the formation of blood clots in the veins of legs or in lungs after knee or hip replacement surgery.Pradaxa is a prescription drug authorized for sale in Canada as a blood thinner to:.The manufacturer was asked to provide all available data on Pradaxa and the risk of liver injury. Health Canada reviewed the potential risk of liver injury with Pradaxa after receiving reports of severe liver injury from the manufacturer. Health Canada will be working with the manufacturers to update the safety information for Pradaxa to inform healthcare professionals and patients about this risk. Health Canada's review concluded that there may be a link between Pradaxa and liver injury.Health Canada reviewed the potential risk of liver injury with Pradaxa after receiving reports of severe liver injury in patients treated with Pradaxa.to treat blood clots and prevent them from reoccurring in the veins of legs and/or lungs to prevent stroke or sudden blocking of a blood vessel due to potential blood clots in patients with an abnormal heart rhythm (atrial fibrillation). Pradaxa (dabigatran etexilate) is a blood thinner authorized for sale in Canada to prevent blood clots from forming in the veins of legs or in lungs after knee or hip replacement surgery.Pradaxa (dabigatran etexilate) Potential Safety Issue ![]()
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