Other safety alerts
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| Canada: Summary Safety Review: Veklury (remdesivir): Assessing the potential risk of sinus bradycardia |
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Health Canada announces that it reviewed the potential risk of sinus bradycardia with the use of Veklury following the submission of international case reports of sinus bradycardia from the manufacturer.
Sinus bradycardia occurs when the heart beats slower than normal. Sinus bradycardia can very rarely cause symptoms, such as dizziness, tiredness, shortness of breath, and chest discomfort.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, published literature, clinical trials, and information received from the manufacturer. At the time of the review, Health Canada had not received any Canadian reports of sinus bradycardia related to Veklury use. However, there was 1 Canadian case from the published literature. Health Canada assessed 47 (46 international and 1 Canadian) case reports of sinus bradycardia in patients receiving Veklury. Thirty of the international cases were from the Canada Vigilance database. Of the 47 case reports, 39 cases were found to be possibly linked to the use of Veklury, 6 cases were unlikely to be linked, and 2 cases did not have enough information to be further assessed. In all 39 cases assessed as possibly linked, existing medical conditions and/or COVID-19 illness may have contributed to sinus bradycardia.
Health Canada also looked at additional information available from 11 articles in published scientific literature and 7 studies provided by the manufacturer on the risk of sinus bradycardia with Veklury use. In general, there is limited information from these sources suggesting that treatment of COVID-19 patients with Veklury can lead to sinus bradycardia.
Health Canada's review of the available information concluded that a link between the use of Veklury and the risk of sinus bradycardia is possible. Health Canada will work with the manufacturer of Veklury to update the Canadian product safety information to inform healthcare professionals and patients about the potential risk of sinus bradycardia.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00271
In Hong Kong, there is one registered pharmaceutical product containing remdesivir, namely Veklury Powder for Concentrate for Solution for Infusion 100mg (HK-66766). The product is registered by Gilead Sciences Hong Kong Limited, and is a prescription-only medicine. The product is indicated for SARS-CoV-2 Infection and is conditionally approved with very limited safety, efficacy, and quality data for public health emergency to satisfy local unmet medical need and the registration status is subjected to be reviewed by the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee (the Committee).
So far, the Department of Health (DH) has received one case of adverse drug reaction related to remdesivir, but this case is not related to sinus bradycardia.
Related news was previously issued by European Medicines Agency, and was posted on the Drug Office website on 16 Feb 2021 and 12 Jun 2021. Letters to inform local healthcare professionals were issued by the DH on 15 Jun 2021. As previously reported, the matter will be discussed by the Committee.
Ends/Thursday, Aug 19, 2021
Issued at HKT 15:00
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