In recent years, concern has arisen following reports about potential hepatic and renal ADRs associated with fluoroquinolones, including levofloxacin (1, 2). The paper investigating hepatic ADRs has resulted in the UK Medicines and Healthcare Products Regulatory Agency (MHRA) publishing an update on the indications for levofloxacin, restricting some of its use as a first-line agent (3). However, responding to this, the expert Committee for Medicinal Products for Human Use (CHMP) presented an official report to the European Medicines Agency (EMA). They concluded that while there was a need for harmonization of product information, the risk-benefit ratio of levofloxacin is considered to be favorable. To further clarify this issue, Prof. Naber reviewed the studies and reported that the hepatic and renal actions may simply be a class effect. The consensus of their findings was that the risk-benefit profile of levofloxacin remains positive.
(1) Paterson JM, et al. CMAJ 2012; 184: 1565-70.
(2) Bird ST, et al. CMAJ 2013; 185: E475-82.
(3) Drug Safety Update, MHRA. 2012, Volume 6: Issue 2, S2, Sep 2012.
An Updated Summary of Levofloxacin's Role in Treating Respiratory Tract Infections and Urinary Tract Infections
Levofloxacin has a long-established track record. It has been marketed in 124 countries with more than 851 million patients treated. Its safety and efficacy have been confirmed with global practice guidelines.
In cases of respiratory tract infections (RTIs), involving the risk of resistant pathogens, such as PRSP, MRSP, ampicillin-resistant H. influenzae, macrolide-resistant M. pneumoniae, and multi-drug resistant P. aeruginosa, fluoroquinolones, in particular levofloxacin, offer important therapeutic options based upon PK/PD and risk-benefit considerations.
In cases of severe and/or healthcare associated UTIs, fluoroquinolones, in particular levofloxacin, have shown good clinical outcomes, based upon excellent antimicrobial activity and offer important therapeutic options based upon PK/PD and risk-benefit considerations.
The risk-benefit ratio of levofloxacin is considered to be favorable and in keeping with the therapeutic aim and goals of physicians.