其 他 安 全 警 示
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| Canada: Summary Safety Review: Ceftriaxone-containing products: Assessing the potential risk of encephalopathy (English only) |
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Health Canada announces that it reviewed the potential risk of encephalopathy in patients treated with ceftriaxone-containing products. The safety review was triggered by a publication in the Journal of the Neurological Sciences reporting brain related adverse drug reactions with the use of ceftriaxone. Encephalopathy is a disease of the brain that alters its function.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases and scientific and medical literature. Health Canada reviewed 29 cases (5 Canadian and 24 international) of encephalopathy reported with the use of ceftriaxone. The 24 international cases included 18 reported to the Canada Vigilance database and 6 that were only available through the scientific and medical literature. Of the 29 cases, 17 (including 2 Canadian) were found to be possibly linked to the use of ceftriaxone, 8 cases (including 3 Canadian) were not likely to be linked, and 4 cases did not have enough information to be assessed. None reported drug-related death. Assessing the risk of encephalopathy related to the use of ceftriaxone-containing products in these reports was challenging due to incomplete case details and other contributing factors, including existing medical conditions and other medications taken by the patients. Health Canada also assessed 5 studies and 3 review articles from the published scientific literature. The review of these publications supported a link between the risk of encephalopathy and the use of ceftriaxone.
Health Canada's review of the available information concluded that there may be a link between the use of ceftriaxone-containing products and the risk of encephalopathy. Health Canada will work with the manufacturers of ceftriaxone-containing products to update the Canadian product safety information to include the risk of encephalopathy.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00257
In Hong Kong, there are 40 registered pharmaceutical products containing ceftriaxone. All products are prescription-only medicines. So far, the Department of Health (DH) has received 6 cases of adverse drug reaction related to ceftriaxone, of which one case is related to coma and cerebral edema. The risk of adverse neurologic events (including encephalopathy) associated with the use of ceftriaxone is documented in overseas reputable drug references such as the “AHFS Drug Information”. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Thursday, Feb 4, 2021
Issued at HKT 16:00
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