Latest industry information on the safety profile of levofloxacin in Japan

This paper focuses on the development of four major adverse drug reactions (ADRs) associated with some fluoroquinolones: convulsions, phototoxicity, c ardiac effects, and hepatotoxicity. CNS adverse events have been linked to fluoroquinolone administration, including seizures, which are more likely w ith co-administration of NSAIDs. Only 61 cases of convulsions have been rep orted with levofloxacin, with 33 of those affected having received NSAIDs. The assumed rate of serious convulsions was as low as 1/ 65,000 with NSAIDs and 1/260,000 without NSAIDs. Levofloxacin has a very low phototoxicity-in ducing potential confirmed by preclinical animal studies and the results of post-marketing surveillance (PMS). Pre-clinical results demonstrated that levofloxacin was 20 times less phototoxic than sparfloxacin and PMS data sh ow that serious phototoxicity develops in only 1 in 1.8 million cases treat ed with levofloxacin. While many fluoroquinolones are associated with cardi ac effects, pre-clinical data has shown that compared with sparfloxacin and grepafloxacin, levofloxacin has no effect on myocardial conduction. PMS da ta further support the safety of levofloxacin in this regard. While trovafl oxacin is associated with serious hepatic problems, PMS data demonstrates t hat levofloxacin has a very low incidence of 1/ 100,000 hepatic effects. Th ese results were confirmed in a prospective study that confirmed a low 1.3% incidence rate for all ADRs associated with levofloxacin. Copyright (C) 20 01 S. Karger AG, Basel.