Post-marketing surveillance of the safety of levofloxacin in Japan.
BACKGROUND
Central nervous system reactions to new quinolones, such as convulsions due to interaction with nonsteroidal anti-inflammatory drugs (NSAIDS), have attracted increased attention in Japan.


METHODS
The safety of levofloxacin (LVX) was investigated in Japan by post-marketing surveillance and reviewing spontaneous reports.


RESULTS
Post-marketing surveillance was performed in 16,117 patients between 1994 and 1996. The incidence of adverse reactions was 1.3% (203/16,117), being comparable with that for ofloxacin or that shown by phase II/III studies. Among 4,977 patients receiving concomitant NSAID treatment, the overall incidence of adverse reactions and the incidence of neurological reactions (including convulsions) did not significantly differ from those in patients without anti-inflammatory therapy. Review of the spontaneous reports on convulsions showed that patients with nephropathy, patients over 75 years and patients with a history of convulsive diseases were more likely to develop convulsions during LVX therapy.


CONCLUSIONS
LVX should be used cautiously in patients with the above risk factors.
Yamaguchi
Hiroki
H
Product Lifecycle Management Department, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan. yamagb0n@daiichipharm.co.jp
Kawai
Hitomi
H
Matsumoto
Takuyuki
T
Yokoyama
Hiroo
H
Nakayasu
Toshio
T
Komiya
Masahiro
M
Shimada
Jingoro
J
D000125:Achilles Tendon / Q000187:drug effects / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D001424:Bacterial Infections / Q000188:drug therapy / Q000453:epidemiology; D056486:Chemical and Drug Induced Liver Injury; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007564:Japan / Q000453:epidemiology; D064704:Levofloxacin; D008107:Liver Diseases / Q000453:epidemiology; D008133:Long QT Syndrome / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000009:adverse effects*; D010787:Photosensitivity Disorders / Q000139:chemically induced / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D012640:Seizures / Q000139:chemically induced / Q000453:epidemiology; D016171:Torsades de Pointes / Q000139:chemically induced / Q000453:epidemiology
D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D015242:Ofloxacin