Other safety alerts
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| Canada: Summary Safety Review: Cyclosporine: Assessing the potential risk of hearing impairment |
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Health Canada announces that it reviewed the potential risk of hearing impairment with the use of cyclosporine (cyclosporin A). The safety review was triggered by a labelling update for cyclosporine-containing products by the European Medicines Agency.
Cyclosporine is a prescription drug authorized for sale in Canada for the prevention and treatment of rejection after an organ or bone marrow transplant, the prevention and treatment of graft-versus-host-disease (a complication of bone marrow transplantation) and the treatment of certain autoimmune diseases.
Health Canada reviewed the available information provided by manufacturers, and from searches of the Canada Vigilance database, international databases and the scientific literature. Health Canada reviewed 2 international cases of hearing impairment in patients taking cyclosporine that were reported in the scientific literature. Both cases were found to be possibly linked to the use of cyclosporine. However, the cases reviewed provided limited evidence for a definitive link due to study limitations and other contributing factors that may have resulted in hearing impairment.
Health Canada also reviewed 11 articles published in the scientific literature. Overall, the scientific literature provided insufficient evidence to support a link between cyclosporine and hearing impairment in the post-market setting due to conflicting study findings, limitations in study design, and the underlying conditions of patients that may have contributed to the risk.
Health Canada’s review of the available information did not find sufficient evidence in the post-market setting regarding the link between cyclosporine and the risk of hearing impairment to support changes to the Canadian product monograph.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1732114128847
In Hong Kong, there are 11 registered pharmaceutical products for human use containing cyclosporine in oral and injectable forms. All products are prescription-only medicines. So far, with regard to cyclosporine, the Department of Health (DH) has received 71 cases of adverse drug reaction, but these cases were not related to hearing impairment. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Dec 20, 2024
Issued at HKT 17:30
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