US FDA FAERS and quinolones

Some case reports on Quinolones, a potent and globally popular group of antibiotics that are used to treat a wide range of infections, have raised concern about their possible association with acute hepatic failure (AHF). Data from the US FDA Adverse Event Reporting System were evaluated for signals of AHF in association with systemically administered quinolone antibiotics.

A recent study published by RSI’s Mohamed Taher, Franco Momoli, Donald Mattison and Daniel Krewski in the journal JGH Open: An open access journal of gastroenterology and hepatology, has shown that only ciprofloxacin displayed a marginal and significant AHF signal (PRR: 1.85 [1.21, 2.81]; EBGM: 1.54 [1.06, 1.81]); moxifloxacin, levofloxacin, and ofloxacin showed weak and nonsignificant signals.

The research team concluded that further pharmacovigilance studies are required to confirm the association between ciprofloxacin and AHF seen in the present analysis.

The paper is available by clicking here.