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Cefotaxime and cephalosporins: adverse reactions in perspective
Abstract:
Cefotaxime was used to treat infections in 2,579 patients during phase II and phase III clinical trials. This paper summarizes the adverse reactions reported to Hoechst-Roussel Pharmaceuticals (Somerville, NJ) during the treatment of these infections. Cefotaxime caused adverse reactions that are caused by all other cephalosporins, including pain at the site of injection (31.9%), thrombophlebitis (4.9%), skin rash (1.8%), thrombocytopenia (3.8%), glomerulotubular dysfunction (1.4%), diarrhea (1.2%), and superinfection (1.1%). Compared with cefazolin, cefotaxime caused pain on injection, phlebitis, and diarrhea more commonly (P less than 0.05) but caused superinfection less commonly (P less than 0.04). Since these data were obtained from many different sources by diverse methods, further controlled trials are needed to substantiate these differences. However, the adverse reactions caused by cefotaxime appear to be similar in spectrum and severity to those caused by other cephalosporins.
Insights
Cefotaxime, a cephalosporin antibiotic, caused adverse reactions similar to other cephalosporins in clinical trials. Common side effects included injection site pain and thrombophlebitis, with some differences noted compared to cefazolin.
Area of Science:
- Pharmacology
- Infectious Diseases
- Clinical Trials
Background:
- Cefotaxime is a third-generation cephalosporin antibiotic used for treating various infections.
- Understanding the adverse reaction profile of cefotaxime is crucial for safe clinical practice.
Purpose of the Study:
- To summarize and analyze the adverse reactions associated with cefotaxime treatment.
- To compare the adverse event profile of cefotaxime with other cephalosporins, specifically cefazolin.
Main Methods:
- Analysis of adverse reactions reported during phase II and phase III clinical trials involving 2,579 patients treated with cefotaxime.
- Comparison of adverse reaction frequencies between cefotaxime and cefazolin.
Main Results:
- Cefotaxime exhibited adverse reactions common to cephalosporins, including pain at injection site (31.9%) and thrombophlebitis (4.9%).
- Compared to cefazolin, cefotaxime showed higher incidences of injection site pain, phlebitis, and diarrhea (P < 0.05), but a lower incidence of superinfection (P < 0.04).
Conclusions:
- Adverse reactions of cefotaxime are generally similar in spectrum and severity to other cephalosporins.
- Further controlled trials are recommended to confirm observed differences between cefotaxime and cefazolin.
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