2001 Volume 49 Issue 8 Pages 500-514
The 6-year cefdinir (CFDN) postmarketing surveillance program (1991-1997) was completed and an application was made for CFDN reapproval in 1997. CFDN safety and efficacy were reconfirmed by reexamination resulting in reapproval in 1999. The surveillance program included 11, 352 cases from 2, 448 institutions nationwide.Of these, 11, 082 were evaluated for safety and 9, 449 for efficacy.The summary is as follows:
1. The incidence of adverse reactions including abnormal laboratory findings was 1.12%(124/11, 082), lower than the incidence (8.74%, 230/2, 633) in premarketing studies.Frequently observed adverse reactions were liver and biliary system disorders (0.51%), e. g., increased AST (GOT) and ALT (GPT);gastrointestinal system disorders (0.39%), e. g., diarrhea;skin and appendages disorders (0.39%), e. g., exanthema;and metabolic and nutritional disorders (0.10%), e. g., increased Al-P.
2. Clinical efficacy by diagnosis in 9, 449 cases ranged from 82.5% to 100.0%, with a mean of 89.8%. Elimination of pathogenic microorganisms exceeded 90% for almost all bacteria.Both efficacy and elimination were approximately equivalent to those in premarketing studies.
