ADR that result in revision of patient information
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| Canada: Summary Safety Review - Opsumit (macitentan) - Assessing the potential risk of liver injury |
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Health Canada announces that it reviewed the potential risk of liver injury with Opsumit (macitentan) use following reports of liver injury internationally that led to an update to the US product safety information for this drug.
At the time of the review, the Canadian product safety information for Opsumit included a warning about potential effects on the liver that had been observed with the group of drugs to which Opsumit belongs. The Canadian product safety information also included requirements for blood tests to monitor liver function.
Health Canada looked at 15 Canadian reports of liver injury with Opsumit from the Canada Vigilance database. Of these reports, 14 were not found to be relevant to this review (e.g., reports that were duplicates, that did not meet the definition of liver injury, or reports where the patient had a history of liver disease). In the 1 remaining case, it was determined that the liver injury was unlikely to be linked to the use of Opsumit. Health Canada also assessed 16 international reports (1 published) that were found to be relevant to the review. There was a link between the risk of liver injury and the use of Opsumit in 1 report. The link was found to be possible in 13 reports and unlikely in 1 report. In the remaining 1 report, the link could not be assessed due to the nature of the information provided. Death was reported in 1 of the 13 cases where the risk of liver injury was found to have a possible link with the use of Opsumit. However, the death was not linked to Opsumit, but was the result of disease progression. In the majority of the reports assessed, other factors may have also caused the liver injury, such as: heart failure that results from pulmonary arterial hypertension (PAH), other conditions linked with PAH, or the use of other medications for PAH. No published studies assessing the risk of liver injury with the use of Opsumit were identified in the literature.
Health Canada’s review found that there may be a link between Opsumit and liver injury. Health Canada will notify the manufacturer to update the product safety information for Opsumit in order to inform healthcare professionals and patients about the potential for liver injury.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00220
In Hong Kong, Opsumit Tablets 10mg (HK-64419) is a registered pharmaceutical product containing macitentan. The product is registered by DKSH Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction related to macitentan, but these cases are not related to liver injury. 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/Saturday, Mar 2, 2019
Issued at HKT 12:00
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