ADR that result in revision of patient information
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| Canada: Summary Safety Review: Tecentriq (atezolizumab): Assessing the potential risk of autoimmune hemolytic anemia |
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Health Canada announces that it reviewed the potential risk of autoimmune hemolytic anemia (AIHA) in patients treated with Tecentriq. This review was triggered by safety information from clinical trials and from published scientific literature that support a possible link between the use of Tecentriq and the risk of AIHA. AIHA is a condition where the body's immune system attacks and destroys its own red blood cells.
Health Canada reviewed information received from the manufacturer, as well as information from searches of the Canada Vigilance Dabatase, international databases, and published literature. Health Canada's review focused on 36 case reports (one Canadian, 35 foreign) in order to assess the link between the use of Tecentriq and the risk of AIHA. Of the 36 case reports, 5 reports (none Canadian) met the criteria for further assessment. A link between Tecentriq use and AIHA could not be ruled out for these 5 reports; 3 reports were found to be probably linked to the use of Tecentriq and 2 reports were possibly linked. The remaining 31 reports could not be assessed further due to factors such as limited information in the reports, or patients taking other medications at the same time that could also cause AIHA. Health Canada also looked at additional information available from 56 studies in published scientific literature. Health Canada's review of these published studies supported a possible link between the use of Tecentriq and the risk of AIHA.
Health Canada's review of the available information concluded that there may be a link between the use of Tecentriq and the risk of AIHA. Health Canada is working with the manufacturer to update the Canadian product safety information for Tecentriq to include the risk of AIHA.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00258
In Hong Kong, Tecentriq Concentrate For Solution For Infusion 1200mg/20ml (HK-65567), Tecentriq Concentrate For Solution For Infusion 1200mg/20ml (HK-66341) and Tecentriq Concentrate For Solution For Infusion 840mg/14ml (HK-66613) are registered pharmaceutical products containing atezolizumab. All products are registered by Roche Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 85 cases of adverse drug reaction related to atezolizumab, but these cases are not related to autoimmune hemolytic anemia. 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/Thursday, Feb 4, 2021
Issued at HKT 16:00
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