Summary Safety Review - Cefuroxime-containing products - Assessing the Potential Risk of Kounis Syndrome

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: 2021-03-04

Product

Cefuroxime-containing products

Potential Safety Issues

Kounis syndrome, a condition where there is a sudden reduction of blood flow to the heart caused by a severe allergic reaction

Key Messages

  • Cefuroxime is a prescription antibiotic drug authorized for sale in Canada to treat a wide range of bacterial infections in many different parts of the body, or to prevent infections during surgery.
  • Health Canada reviewed the potential risk of Kounis syndrome with the use of cefuroxime-containing products after becoming aware of cases reported in the published literature.
  • Health Canada's review of the available information could not confirm a link between the use of cefuroxime-containing products and the risk of Kounis syndrome.
  • Health Canada will continue to monitor safety information involving cefuroxime-containing products, as it does for all health products on the Canadian market.

Overview

Health Canada reviewed the potential risk of Kounis syndrome with the use of cefuroxime-containing products. The safety review was triggered by foreign case reports published in the medical literature.

Kounis syndrome may occur when an allergic event, including a severe allergic reaction (anaphylactic reaction), results in a sudden reduction of blood flow to the heart. This rare condition may be due in part to a sudden narrowing of the arteries and could lead to the weakening of the heart.

Severe allergic reactions are life-threatening conditions which require a rapid response and for which there are well established clinical guidelines for their diagnosis and treatment (which includes the prompt use of intramuscular epinephrine, etc.). The Canadian safety information for cefuroxime-containing products warns against the risk of severe allergic reactions and recommends the prompt use of intramuscular epinephrine.

Use in Canada

  • Cefuroxime is a prescription antibiotic drug authorized for sale in Canada since 1980 to treat a wide range of bacterial infections in many different parts of the body such as the brain (meningitis), respiratory and urinary tracts, skin, soft tissues, bones and joints. Cefuroxime can also be used to treat gonorrhea (a sexually transmitted disease) or to prevent infections during surgery.
  • Cefuroxime is available as granules for oral (by mouth) suspension under the brand name Ceftin. It is also available as generics in 250 and 500 mg tablets. Injectable cefuroxime products are available as generics, as 0.75, 1.5 or 7.5 g/vial sterile lyophilized powder for reconstitution.

Safety Review Findings

  • Health Canada reviewed the available information from searches of the Canada Vigilance databasea, international databases and published literature.
  • Health Canada assessed 10 case reports (all foreign) of Kounis syndrome related to cefuroxime use, including 9 published in the literature. Of the 10 case reports, 8 were found to be possibly linked to the use of cefuroxime while 2 cases did not have enough information to be assessed. No fatalities were reported.
  • Assessing the risk of Kounis syndrome related to the use of cefuroxime-containing products in these reports was challenging due to several contributing factors, including incomplete case details, inconsistent definitions of Kounis syndrome being used, existing medical conditions and other medications taken by the patients.
  • The review of these reports did not support a link between the use of cefuroxime-containing products and the risk of Kounis syndrome. There was insufficient information in these reports to confirm the role of cefuroxime as being the trigger of the severe allergic reactions, and the role of other medications as the cause of Kounis syndrome could not be ruled out.

Conclusions and actions

  • Health Canada's review of the available information could not confirm a link between the use of cefuroxime-containing products and the risk of Kounis syndrome.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of cefuroxime-containing products and other health products to the Canada Vigilance Program.
  • Health Canada will continue to monitor safety information involving cefuroxime-containing products, 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 cefuroxime-containing products 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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