Other safety alerts
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| Canada: Summary Safety Review: Bacitracin for injection products: Assessing the potential risks of nephrotoxicity and anaphylactic reactions |
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Health Canada announces that it reviewed the potential risks of nephrotoxicity and anaphylactic reactions with the use of bacitracin for injection products further to the United States Food and Drug Administration (FDA) issued 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 for the only approved indication of treating infants with pneumonia and empyema caused by staphylococcus. The FDA also 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.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, and published scientific and medical literature. Health Canada's assessment of the use of bacitracin for injection and nephrotoxicity focused on 10 published international studies, which included more than 280 patient cases. 8 of these studies supported a link between bacitracin and nephrotoxicity, one study had incomplete information on kidney function, and one did not identify a link between bacitracin and nephrotoxicity. At the time of the review, Health Canada had not received any Canadian reports of nephrotoxicity linked to the use of bacitracin for injection products. The safety review also looked at 7 international case reports of kidney toxicity related to the use of bacitracin for injection products. These reports could not be assessed further for causality because of the limited information in the reports, errors in the route of administration, and the use of other medications that may have contributed to nephrotoxicity. Overall, the review found that treatment with bacitracin for injection is often associated with changes in kidney function, which can return to normal if treatment is stopped early, but can progress to kidney damage or failure if continued. There were no case reports of nephrotoxicity linked to the use of bacitracin for injection in Canada.
Health Canada's assessment of the use of bacitracin for injection and anaphylactic reactions focused on 14 articles published in the scientific literature. These publications reported evidence supporting a link between bacitracin use and the risk of anaphylactic reactions. Health Canada also assessed 18 case reports, 3 received from the Canada Vigilance database and 15 from one manufacturer. These 18 case reports included 12 published case reports from the literature articles. There was a link between bacitracin for injection products and anaphylactic reactions in 17 of the 18 cases. Of the 3 case reports from the Canada Vigilance database (1 Canadian and 2 international), a link between the use of bacitracin for injection and anaphylactic reactions was found to be probable in 1 report and possible in the other 2 reports (1 Canadian). Of the 15 international case reports from the manufacturer, 14 cases showed a link between bacitracin use and anaphylactic reactions. Overall, the review found that anaphylactic reactions with bacitracin for injection can occur minutes after starting treatment. Many cases required resuscitation with medication. The review also found that bacitracin for injection was used despite previous allergic reactions to bacitracin. There was a single case report of anaphylactic reaction in Canada that was found to be possibly linked to the use of bacitracin for injection. However, the patient was taking other medications at the same time that could have contributed to the anaphylactic reaction.
Health Canada's review found a possible link between bacitracin for injection products and the risks of nephrotoxicity and anaphylactic reactions. Health Canada has requested that the manufacturers of bacitracin for injection products update the Canadian product safety information and add a Serious Warnings and Precautions Box to further strengthen the information about nephrotoxicity and to include information about anaphylactic reactions.
A review by Health Canada of information on utilization of these products and physician awareness of these risks in Canada is necessary to determine if further measures are needed to mitigate the risks. Health Canada will work with the manufacturers to collect this information.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00250
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 was posted on the Drug Office website on 1 Feb 2020.
Ends/Thursday, Dec 3, 2020
Issued at HKT 16:00
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