A review of the safety profile of cefixime.
Data are reviewed for safety from worldwide clinical trials of 4000 patients and postmarketing studies of 38,000 patients treated with cefixime, a broad-spectrum, bactericidal, beta-lactam stable, third-generation cephalosporin. Adverse experiences were similar in adults and children in all groups, with the most frequent side effects being gastrointestinal in nature. The reported frequency of gastrointestinal adverse experiences was higher in patients in US clinical trials when compared with French, German, or Canadian clinical trials or Canadian or US postmarketing studies. The overall incidence of side effects ranged from 2.7% to 48.2%, and the incidence of gastrointestinal events reported in these studies ranged from 1.4% to 38.6%. Patients infrequently discontinued treatment due to adverse events. The design and methods of data collection in US clinical trials may have resulted in higher frequencies of adverse experiences being reported in US trials when compared with the experiences reported in postmarketing studies and in clinical trials conducted outside of the United States. This is because of the more rigorous methodology used to elicit patient reporting of adverse events in US clinical trials compared with the methodology in postmarketing studies and foreign clinical trials.
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Lederle Laboratories, Pearl River, New York.
D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects*; D020682:Cefixime; D002439:Cefotaxime / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003625:Data Collection; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D011358:Product Surveillance, Postmarketing; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D014552:Urinary Tract Infections / Q000188:drug therapy*
D000890:Anti-Infective Agents; D020682:Cefixime; D002439:Cefotaxime