Vol.56 No.3 May 2008
Postmarketing study of prulifloxacin tablets
Pharmacovigilance Dept. Reliability & Quality Assurance Center, Meiji Seika Kaisha, Ltd., 2-4-16 Kyobashi, Chuo-ku, Tokyo, Japan
Abstract
Prulifloxacin(PUFX, Sword® Tablets 100), an oral quinolone antibiotic, was approved for marketing on October 8, 2002. In the 3 years from January 2004 to 2007, we studied practical use in compliance with new Good Postmarketing Surveillance Practices(GPMSP).
Of 4,034 cases collected from 539 medical institutes nationwide, we evaluated 3,076 for safety and 2,881 for clinical efficacy, with the following results:
1) The incidence of adverse drug reactions, 1.01% (31 cases/3,076 cases), was lower than that in clinical studies before marketing approval, 9.20% (270 cases/2,936 cases). The most frequently observed adverse drug reaction was diarrhea, at 0.33% (10 cases/3,076 cases). No serious adverse reaction was observed.
2) Clinical efficacy in each infection was from 93.2-100%, in each disease 90% or more excluding pneumonia, and results were equivalent to those in studies before marketing approval.
Key word
prulifloxacin, post-marketing surveillance, safety, efficacy
Received
December 18, 2007
Accepted
February 26, 2008
Jpn. J. Chemother. 56 (3): 317-329, 2008
