Summary Safety Review - Sevoflurane – Re‑Assessing the potential risk of slow heartbeat (bradycardia) in children with Down syndrome

April 9, 2018

Product

Sevoflurane

Potential Safety Issue

Slow heartbeat (bradycardia) in children with Down syndrome (DS)

Key Messages

  • Sevoflurane is an anesthetic drug used by healthcare professionals during surgeries or other medical procedures in children and adults.
  • Health Canada re-assessed the potential risk of slow heartbeat (bradycardia) with the use of sevoflurane in children with Down syndrome (DS), because of evidence published since the last safety review.
  • Health Canada’s review concluded that there is a link between sevoflurane and the risk of bradycardia in children with DS. Health Canada has recommended that the manufacturers of sevoflurane products strengthen the existing product safety information to include the evidence reported in published studies about this risk in children with DS.

Overview

In 2014, Health Canada reviewed the potential risk of slow heartbeat, known as bradycardia, with the use of sevoflurane in children with Down syndrome (DS). The product safety information for sevoflurane was updated in Canada to mention the possibility of this risk. Before the 2014 safety review, the product safety information already mentioned that bradycardia is an adverse reaction that could happen in both adults and children in general. Health Canada re-assessed this issue following the publication of additional adverse reaction reports of bradycardia in children with DS that were given sevoflurane.

Use in Canada

  • Sevoflurane is an anesthetic drug used by healthcare professionals during surgeries or other medical procedures in children and adults.
  • Sevoflurane is given as a gas, inhaled through a breathing mask or through a breathing tube attached to the anesthesia machine.
  • Sevoflurane has been marketed in Canada since 1995.

Safety Review Findings

  • At the time of the current review, Health Canada had received 1 Canadian reportFootnote a of bradycardia in a child with DS, possibly related to the use of sevoflurane. The report described that bradycardia happened around the time sevoflurane was given to the child but further information was not provided.
  • The current safety review identified 17 international reports of bradycardia in children with DS that were treated with sevoflurane. In 3 reports, there was a link between bradycardia and the use of sevoflurane. In 11 reports, the link between sevoflurane and bradycardia was possible, but there were other factors such as heart defects or other medications being given that may have also slowed the heart. In 2 reports, it was considered that the slow heartbeat was likely caused by the medical procedure rather than sevoflurane. The remaining report could not be assessed because it did not provide enough information.
  • Two published studies about sevoflurane use suggest that children with DS are more likely to experience bradycardia than children without DS.
  • Additionally, evidence suggests that children with DS are more at risk of bradycardia, even if they are not receiving medications. For example, heart defects are more frequent in children with DS and their nervous system could react differently to stress, by slowing down the heartbeat.

Conclusions and Actions

  • Health Canada’s review concluded that there is a link between sevoflurane and the risk of bradycardia in children with DS. Health Canada has recommended that the manufacturers of sevoflurane products strengthen the existing product safety information to include the data reported in published studies about this risk in children with DS.
  • In addition, Health Canada will publish a notice in the Health Product InfoWatch to inform Canadians and healthcare professionals of this updated information.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this and any other health products.
  • Health Canada will continue to monitor side effects involving sevoflurane, 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 if and when new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

Footnote a

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

Return to footnote a referrer

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