Summary Safety Review - Veklury (remdesivir) - Assessing the Potential Risks of Acute Kidney Injury (AKI) and Acute Renal Failure (ARF)

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: 2021-04-09

Product

Veklury (remdesivir)

Potential Safety Issue

Acute kidney injury, a sudden decrease in kidney function; or acute renal failure, kidney failure over a very short period of time.

Key Messages

  • Veklury (remdesivir) is authorized for sale in Canada to treat coronavirus disease 2019 (COVID-19) in adults and adolescents with pneumonia (a lung infection) and requiring oxygen. This authorization includes conditions on the manufacturer to provide additional information to Health Canada on the drug's performance, along with active safety monitoring.
  • Health Canada reviewed the potential risks of acute kidney injury (AKI) and acute renal failure (ARF) with the use of Veklury. The safety review was triggered by international case reports, received from the manufacturer, of AKI/ARF in patients treated with Veklury.
  • At the time of the review, the Canadian product safety information (Canadian Product Monograph) for Veklury included information on potential kidney toxicity and recommended measuring kidney function before starting Veklury and during treatment. It also advised against using Veklury with drugs that reduce kidney function, or in patients with severe kidney problems. The purpose of this review was to assess if additional actions were required in Canada.
  • Based on Health Canada's review of the available information, a direct link between the use of Veklury and the risk of AKI/ARF could not be established. The available information does not suggest a change in the overall safety profile for Veklury. Presently, the Canadian Product Monograph (CPM) for Veklury provides appropriate information on kidney toxicity and recommendations on usage, therefore, no updates are required at this time.
  • Health Canada will continue to monitor the safety of Veklury, as it does for all health products on the Canadian market, to identify and assess potential harms.

Overview

Health Canada reviewed the potential risks of acute kidney injury and acute renal failure with Veklury (remdesivir) to analyse the emerging information and determine if further measures were needed in Canada. This safety review was initiated following the submission of international case reports of AKI/ARF from the manufacturer.

At the time of the review, the CPM for Veklury included information on potential kidney toxicity and recommended blood tests before and during Veklury treatment to check for kidney problems. Veklury should not be given with drugs that reduce kidney function or used in patients with severe kidney problems.

Use in Canada

  • Veklury is a prescription drug authorized for sale in Canada to treat coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older with body weight 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. Currently, Veklury is available for sale as a sterile powder for solution for infusion (100 mg/vial). The sterile solution (100 mg/20mL) formulation is not marketed at this time.
  • There were about 21,000 vials purchased by Canadian hospitals from September to December 2020.

Safety Review Findings

  • Health Canada reviewed the available information from searches of the Canada Vigilance databasea, international databases, published literature, and information received from the manufacturer.
  • At the time of the review, Health Canada had not received any Canadian reports of AKI/ARF related to Veklury use.
  • Health Canada reviewed 88 international case reports of AKI/ARF in patients receiving Veklury. 60 of these foreign cases were from the Canada Vigilance database. Of the 88 case reports, 64 cases were found to be possibly linked with the use of Veklury, 14 cases were unlikely to be linked, and 10 cases did not have enough information to be further assessed. In all 64 cases assessed as possibly linked, the role of Veklury in causing AKI/ARF could not be established due to several contributing factors such as, other medications taken by the patients, existing medical conditions and/or COVID-19 illness that may have contributed to AKI/ARF.
  • Health Canada also looked at additional information available from 10 articles in published scientific literature and 4 studies provided by the manufacturer on the risk of AKI/ARF with Veklury use. Overall, there is limited information suggesting that treatment with Veklury in COVID-19 patients can lead to AKI/ARF.

Conclusions and actions

  • Health Canada's review could not establish a direct link between the use of Veklury and the risk of AKI/ARF. The Canadian product safety information for Veklury includes information on kidney toxicity and recommendations on usage. Therefore, the safety information for Veklury is appropriate at this time.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of Veklury and other health products to the Canada Vigilance Program.
  • 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 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

  1. Canadian reports can be accessed through the Canada Vigilance Online Database.

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