ADR that result in revision of patient information
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| Canada: Summary Safety Review: Oral anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban and warfarin): Assessing the potential risk of splenic rupture |
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Health Canada announces that it reviewed the potential risk of splenic rupture with the use of oral anticoagulants. The safety review was triggered by international reports concerning this risk in patients taking rivaroxaban where no trauma or other risk factor was identified.
Oral anticoagulants are prescription drugs, also known as blood thinners, authorized for sale in Canada to prevent blood clots from forming after knee or hip replacement surgery; reduce the risk of stroke (damage to part of the brain caused by an interruption of its blood supply) or systemic embolism (the sudden blocking of a blood vessel by a blood clot) in people who have a heart condition called atrial fibrillation (irregular heart beat); treat deep vein thrombosis (blood clots in the veins of the legs) and pulmonary embolism (blood clots in the blood vessels of the lungs), and reduce the risk of them occurring again.
Health Canada reviewed the available information from searches of the Canada Vigilance database and the scientific literature. Health Canada reviewed 42 cases (3 Canadian and 39 international) of splenic rupture in patients taking oral anticoagulants, including 39 from the published literature. Of the 42 cases, 1 was found to be probably linked to the use of oral anticoagulants, 21 (1 Canadian) were found to be possibly linked, 16 were unlikely to be linked, and 4 (2 Canadian) could not be assessed due to missing information.
Besides having taken oral anticoagulants, in 9 of the 21 possible cases, there was no other possible explanation (for example, trauma or existing medical condition) reported for the splenic rupture. However, atraumatic rupture of the spleen is known to occasionally occur. Given the known increased risk of bleeding associated with anticoagulants, patients taking these drugs are at an increased risk of bleeding within their spleen, which can lead to a rupture of its capsule (the outer layer surrounding the spleen).
Health Canada also reviewed the findings from a study that examined over 27,000 international reports of suspected adverse drug reactions associated with oral anticoagulants. The findings showed that events of splenic rupture were more frequently reported than expected with these drugs, thereby supporting a link.
Health Canada’s review of the available information found a possible link between oral anticoagulants and the risk of atraumatic splenic rupture. Health Canada is working with the manufacturers to update the Canadian product monograph for all oral anticoagulants to include the risk of atraumatic splenic rupture.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1740076495316
In Hong Kong, there are registered pharmaceutical products containing apixaban (6 products), dabigatran (6 products), edoxaban (3 products), rivaroxaban (20 products) and warfarin (4 products). All products are prescription-only medicines.
So far, the Department of Health (DH) has received adverse drug reaction with regard to apixaban (66 cases), dabigatran (22 cases), edoxaban (29 cases) and rivaroxaban (26 cases), but these cases were not related to splenic rupture. With regard to warfarin, the DH has received 15 cases of adverse drug reaction, of which one case was reported as splenic rupture.
In light of the above Health Canada’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Mar 28, 2025
Issued at HKT 17:45
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