Vol.53 No.2 February 2005

Early postmarketing phase vigilance for pazufloxacin mesilate, a new quinolone for intravenous administration

Keiji Maki¹⁾, Toshiro Yamada¹⁾, Norio Abe¹⁾, Toru Hiraiwa¹⁾, Shigekazu Hashimoto¹⁾, Yoshiaki Tsutsui²⁾ and Kyouko Yamagata³⁾

¹⁾Pharmacovigilance & Surveillance Department, Toyama Chemical Co., Ltd.,
3-25-1 Takada, Toshima-ku, Tokyo, Japan
²⁾Postmarketing Division, Taishotoyama Pharmaceutical Co., Ltd.
³⁾Drug Safety & Evaluation Department, Mitsubishi Pharma Corporation

Abstract

Early postmarketing phase vigilance for pazufloxacin mesilate (PZFX) was conducted from September 2002 to March 2003 based on "Guidelines for Implementation of Early Postmarketing Phase Vigilance Surveillance for Prescription Drugs, etc. (December 27, 2000)."
We first organized information delivery to provide monthly updates on adverse drug reactions to physicians and pharmacists working at all hospitals where PZFX was used.
A total of 203 adverse drug reactions in 180 patients were reported. Serious adverse reactions (43), most of which were already reported for other new quinolones, such as ciprofloxacin and ofloxacin, were observed in 40 patients.
That is; the main serious adverse reactions were convulsion (5), tonic convulsion (1), interstitial lung disease (2), pseudomembranous colitis (2), hepatic function abnormal (4), liver disorder (3), hepatic failure (1), dermatitis medicamentosa (3), rhabdomyolysis (2), acute renal failure (2), anuria (1), renal failure (1), platelet count decreased (3) and thrombocytopenia (1).

Key word

early postmarketing phase vigilance, pazufloxacin mesilate, safety

Received

November 4, 2004

Accepted

December 17, 2004

Jpn. J. Chemother. 53 (2): 151-157, 2005