Summary Safety Review - Veklury (remdesivir) - Assessing the Potential Risk of Sinus Bradycardia
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2021-08-18
Product
Veklury (remdesivir)
Potential Safety Issue
Sinus bradycardia, when the heart beats more slowly than usual
Overview
Use in Canada
- Veklury is a prescription drug authorized for sale in Canada to treat COVID-19 in adults and adolescents (aged 12 years and older with body weight of at least 40 kg) with pneumonia and requiring oxygen. This authorization includes conditions requiring the manufacturer to provide additional information to Health Canada on the drug's performance, along with active safety monitoring.
- Veklury has been marketed in Canada since October 2020 as a sterile powder for solution for infusion (100 mg/vial).
- There were about 45,000 vials purchased by Canadian hospitals from October 2020 through April 2021.
Safety Review Findings
- Health Canada reviewed the available information from searches of the Canada Vigilance databasea, 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.
Conclusions and actions
- 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.
- Health Canada will continue to monitor safety information involving Veklury, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should any new health risks be identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of Veklury both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
Footnotes
Canadian reports can be accessed through the Canada Vigilance Online Database.