Other safety alerts
|
| |
| Canada: Bacitracin for Injection (50,000 IU per vial) and the risk of nephrotoxicity and anaphylactic reactions |
| |
Health Canada announces that it recently conducted a safety review and concluded that there may be a link between the use of bacitracin for injection products and the risk of nephrotoxicity and serious hypersensitivity, including allergic contact dermatitis and/or anaphylaxis. This safety review was triggered by the United States Food and Drug Administration (FDA) Drug Safety Communication dated 31 Jan 2020. In that communication, the FDA requested all current United States manufacturers of bacitracin for injection to voluntarily withdraw their product from the United States market. The FDA review determined that United States healthcare professionals no longer use bacitracin for injection, and considered the availability of other approved, effective treatments that do not have the same serious risks, including nephrotoxicity and anaphylactic reactions.
Health Canada’s review did not include non-prescription bacitracin-containing products marketed as ointments since no safety concerns for these products were identified in the FDA’s Drug Safety Communication.
Bacitracin for injection products are now contraindicated in patients with impaired renal function, including those taking nephrotoxic drugs.
To further minimize risks in Canada, Health Canada, in collaboration with the manufacturers of bacitracin for injection products, will update the Contraindications, Warnings and Precautions (including the Serious Warnings and Precautions Box), and Consumer Information sections of the Canadian Product Monographs for all bacitracin for injection products. These updates will strengthen statements regarding the risk of nephrotoxicity, including kidney failure, and include information about serious hypersensitivity, including allergic contact dermatitis and/or anaphylaxis, in patients exposed to bacitracin.
Health Canada will also work with the manufacturers of bacitracin for injection products to collect information on utilization of these products and physician awareness of these risks in Canada. After reviewing this information, Health Canada will determine if further measures are needed to mitigate the risks.
Healthcare professionals are advised to:
- Evaluate renal function before initiating treatment with bacitracin for injection products, daily during therapy, and after treatment has stopped.
- Not use bacitracin for injection products concurrently with other nephrotoxic drugs.
- Not exceed the recommended daily dose. Maintain fluid intake and urinary output at proper levels to avoid nephrotoxicity.
- Discontinue bacitracin for injection products if nephrotoxicity or hypersensitivity reactions occur.
Healthcare professionals are reminded that bacitracin for injection products are not indicated as an irrigation solution for intraoperative prophylaxis nor for pre-soaking of medical devices or implants prior to surgery. Anaphylactic reactions and nephrotoxicity can occur when bacitracin is used in this manner.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74605a-eng.php
In Hong Kong, there is no registered pharmaceutical product containing bacitracin for injection. Related news was previously issued by the United States Food and Drug Administration and Health Canada, and was posted on the Drug Office website on 1 Feb 2020 and 3 Dec 2020.
Ends/Tuesday, Dec 22, 2020
Issued at HKT 15:30
|
| |
|
