Drugs Xagena
The PhVWP ( Pharmacovigilance Working Party ) carried out a review of fluoroquinolones with regard to the risk of QT interval prolongation, triggered by discrepancies noted for some products between the current summaries of product characteristics ( SmPCs ) and the recommendations agreed by the PhVWP in April 2003 in relation to this risk for the SmPC section 4.4 on warnings and precautions of use.
The active substances included in this review were Enoxacin, Gemifloxacin ( EU marketing authorisation application withdrawn ), Levofloxacin, Moxifloxacin, Norfloxacin, Ofloxacin, Pefloxacin, Prulifloxacin and Rufloxacin.
QT interval prolongation is an irregularity of the electrical activity of the heart that places patients at risk of ventricular arrhythmias. The identification of patients at risk of QT interval prolongation induced by a medicine may help to prevent these events.
Fluoroquinolones are broad-spectrum antibacterial agents.
The PhVWP reviewed, for each substance, all available data and information from non-clinical and clinical studies as well as data from post-authorisation studies and spontaneous reporting covering the period from 1 December 1999 to 31 December 2008.
The PhVWP concluded that, with respect to the potential for inducing QT interval prolongation, fluoroquinolones can be divided into three groups based on clinical data and results from in vivo studies and in vitro electrophysiological studies:
1.Fluoroquinolones with a potential for inducing QT interval prolongation; the active substances classified in this group are Gemifloxacin and Moxifloxacin;
2.Fluoroquinolones with a low potential for inducing QT interval prolongation; and the active substances classified in this group are Levofloxacin, Norfloxacin and Ofloxacin;
3.Fluoroquinolones with a very low potential for inducing QT interval prolongation or for which there are insufficient data available to assess their potential completely due to the lack of in vitro electrophysiological studies. The active substances classified in this group are Enoxacin, Pefloxacin, Prulifloxacin and Rufloxacin.
The PhVWP also noted that some fluoroquinolones ( especially those in group 1 ) have the potential for inducing life-threatening torsades de pointes, especially under conditions favouring the development of QT interval prolongation ( hypokalaemia, hypomagnesaemia, bradycardia, congenital or acquired prolongation of the QT interval ). ( Xagena )
Source: EMA, 2011
XagenaMedicine_2011
