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Latest industry information on the safety profile of levofloxacin in Japan
1Drug Safety Administration Department, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.
Abstract:
This paper focuses on the development of four major adverse drug reactions (ADRs) associated with some fluoroquinolones: convulsions, phototoxicity, cardiac effects, and hepatotoxicity. CNS adverse events have been linked to fluoroquinolone administration, including seizures, which are more likely with co-administration of NSAIDs. Only 61 cases of convulsions have been reported 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-inducing potential confirmed by pre-clinical 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 show that serious phototoxicity develops in only 1 in 1.8 million cases treated with levofloxacin. While many fluoroquinolones are associated with cardiac effects, pre-clinical data has shown that compared with sparfloxacin and grepafloxacin, levofloxacin has no effect on myocardial conduction. PMS data further support the safety of levofloxacin in this regard. While trovafloxacin is associated with serious hepatic problems, PMS data demonstrates that levofloxacin has a very low incidence of 1/100,000 hepatic effects. These results were confirmed in a prospective study that confirmed a low 1.3% incidence rate for all ADRs associated with levofloxacin.
Insights
Levofloxacin demonstrates a low incidence of serious adverse drug reactions (ADRs), including convulsions, phototoxicity, cardiac effects, and hepatotoxicity. This safety profile is supported by pre-clinical and post-marketing surveillance data.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Clinical Pharmacology
Background:
- Fluoroquinolones are associated with several major adverse drug reactions (ADRs).
- Central nervous system (CNS) events like convulsions are a concern, particularly with co-administration of NSAIDs.
- Other potential ADRs include phototoxicity, cardiac effects, and hepatotoxicity.
Purpose of the Study:
- To evaluate the incidence and risk of major adverse drug reactions (ADRs) associated with levofloxacin.
- To compare the safety profile of levofloxacin regarding convulsions, phototoxicity, cardiac effects, and hepatotoxicity with other fluoroquinolones.
Main Methods:
- Analysis of post-marketing surveillance (PMS) data for levofloxacin.
- Review of pre-clinical animal studies.
- Examination of reported cases of adverse events, including convulsions, phototoxicity, cardiac effects, and hepatotoxicity.
- Prospective study to confirm ADR incidence rates.
Main Results:
- Levofloxacin shows a low rate of serious convulsions (1/260,000 without NSAIDs, 1/65,000 with NSAIDs).
- Phototoxicity potential is very low (1 in 1.8 million cases).
- Levofloxacin has no observed effect on myocardial conduction compared to other fluoroquinolones.
- Incidence of hepatotoxicity is low (1/100,000).
- Overall ADR incidence in a prospective study was 1.3%.
Conclusions:
- Levofloxacin exhibits a favorable safety profile with a low incidence of major adverse drug reactions.
- The drug is significantly less phototoxic than sparfloxacin and has no cardiac effects compared to sparfloxacin and grepafloxacin.
- Post-marketing surveillance and prospective studies confirm the low risk of serious adverse events associated with levofloxacin.