Summary Safety Review - Cephalosporins - Assessing the Potential Risk of Seizures
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.
Cephalosporins (cephalexin-, cefazolin-, cefadroxil-, cefoxitin-, cefuroxime-, cefprozil-, cefotaxime-, ceftazidime-, ceftriaxone-, cefixime-, cefepime-, ceftobiprole- and ceftolozane-tazobactam-containing products)
Potential Safety Issue
Use in Canada
Cephalosporins are a group of prescription antibiotic drugs authorized for sale in Canada to treat a wide range of bacterial infections, including urinary and respiratory tract infections.
Cephalosporins have been marketed in Canada for over 50 years under different brand names and generics of cephalexin, cefazolin, cefadroxil, cefoxitin, cefuroxime, cefprozil, cefotaxime, ceftazidime, ceftriaxone, cefixime, cefepime, ceftobiprole, and ceftolozane-tazobactam.
Cephalosporins are a widely prescribed group of antibiotic drugs, with approximately 3.6 million prescriptions filled in Canadian retail pharmacies every year.
Safety Review Findings
Health Canada reviewed the available information from searches of the Canada Vigilance databasea, 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.
Conclusions and actions
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 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.
Health Canada will continue to monitor safety information involving cephalosporins, 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.
The analyses that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of cephalosporins both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
Canadian reports can be accessed through the Canada Vigilance Online Database.