其 他 安 全 警 示
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| Canada: Summary Safety Review: Cephalosporins: Assessing the potential risk of seizures (English only) |
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Health Canada announces that it reviewed the potential risk of seizures with the use of cephalosporins (cephalexin, cefazolin, cefadroxil, cefoxitin, cefuroxime, cefprozil, cefotaxime, ceftazidime, ceftriaxone, cefixime, cefepime, ceftobiprole, and ceftolozane-tazobactam). This safety review was triggered by a United States Food and Drug Administration update to the product safety information for a cefazolin-containing product to include the risk of seizures.
Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, as well as medical and scientific literature. Health Canada reviewed 84 cases (7 Canadian and 77 international) of seizures in patients taking cephalosporins. Of the 84 cases, 13 were found to be probably linked to the use of cephalosporins. Sixty-two cases (4 Canadian) were found to be possibly linked, and 3 cases were unlikely to be linked to the use of cephalosporins. Six cases (3 Canadian) could not be assessed.
Health Canada’s review of the available information concluded that there may be a link between the use of cephalosporins and the risk of seizures. At the time of the safety review, the risk of seizures was already included in the Canadian product monograph (CPM) for some cephalosporins. Health Canada will work with the manufacturers to update the CPM for the cephalosporins that do not already include this risk.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00291
In Hong Kong, there are registered pharmaceutical products containing cephalexin (54 products), cefazolin (4 products), cefadroxil (6 products), cefuroxime (31 products), cefotaxime (11 products), ceftazidime (13 products), ceftriaxone (31 products), cefepime (11 products) and ceftolozane-tazobactam (one product). All products are prescription-only medicines. There is no registered pharmaceutical product containing cefoxitin, cefprozil, cefixime or ceftobiprole. So far, the Department of Health (DH) has received adverse drug reaction related to cefazolin (one case), cefuroxime (4 cases), cefotaxime (7 cases), ceftazidime (one case), ceftriaxone (7 cases) and cefepime (3 cases), but these cases were not related to seizures. The DH has not received any case of adverse drug reaction related to cephalexin, cefadroxil or ceftolozane-tazobactam. The risk of seizures associated with the use of cephalosporins is documented in overseas reputable drug references such as the “AHFS Drug Information”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Thursday, Jan 26, 2023
Issued at HKT 16:00
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