2002 Volume 50 Issue 11 Pages 809-825
We conducted a Use-Results Surveillance study of Farom ® tablet (faropenem, FRPM) in the first four years after its launch in 1997, covering 19, 375 cases at 2, 826 institutions nationmide. Of these, safety analyzed in 17, 303 and efficay in 16, 324 excluding inappropriate cases for reasons such as the cases given FRPM off the specified surveillance period. Results were as follows.
1. The incidence of adverse events associated with the use of FRPM (including abnormal laboratory findings) was 2.96%(512 cases), lower than 5.75%(127 of 2, 207 cases) in premarketing studies. Major adverse event were gastrointestinal disorders at 2.38%(412 cases) including diarrhoea and loose bowels (2.1%); skin and appendages disorders at 0.24%(42 cases) including rash. The incidence of diarrhoea and stools loose was lower compared with the reported in premarketing studies. Any symptoms were mild, and resolved by early termination of use. A higher incidence of adverse drug reactions were observed in patients with hypersensitive predisposition and those given 900mg/day of FRPM. We confirmed that adverse drug reactions to less than three days of medication starts.
2. FRPM efficacy exceeded 85.0% for all indication, similar to those observed in premarketing studies.
