Fluoroquinolones and the risk of QT Prolongation

Fluoroquinolones are broad spectrum antibiotics, authorised for a wide range of indications. Those currently authorised in Nigeria include: Ciprofloxacin, Gemifloxacin, Levofloxacin, Moxifloxacin, Nalidixic acid, Norfloxacin, Ofloxacin, Pefloxacin, Sparfloxacin. There are also several combination products.

The potential for fluoroquinolones to cause QT prolongation is recognised and has been previously considered on the basis of available data for the individual substances, as reflected in the product specific information. A further recent European review of study and postmarketing data in relation to QT prolongation and fluoroquinolones concluded that the risk of QT prolongation does not appear to be similar across this class of antibiotics, but that substances may be classified according to their potential to prolong QT interval and precipitate cardiac events (i.e., ventricular arrhythmia).

As Moxifloxacin has been associated with an established potential for increased risk of QT prolongation, prescribers are reminded to use Moxifloxacin only when it is considered inappropriate to use antibacterial agents that are commonly recommended or when these have failed for the treatment of:

  • acute bacterial sinusitis,
  • acute exacerbations of chronic bronchitis,
  • community acquired pneumonia (except severe cases) and
  • mild to moderate pelvic inflammatory disease.

Following assessment of the available evidence, Ciprofloxacin, Levofloxacin and Ofloxacin are considered to have a lower potential to induce QT interval prolongation. It is important to note that in the context of conditions which favour the development of QT prolongation e.g. hypokalaemia, hypomagnesaemia, bradycardia, patients with congenital or acquired QT prolongation, some fluoroquinolones have the potential to induce life-threatening Torsades de Pointes (e.g. Moxifloxacin).

For further information and the complete list of fluoroquinolones considered as part of the review please see the following link: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500100459.pdf

Source:

  1. Irish Medicines Board (DHPCs). Fluoroquinolones and the risk of QT Prolongation. Safe Notices, 2011 Apr 5. Available from: https://www.hpra.ie/docs/default-source/Safety-Notices/apr-5th-fluoroquinolones_dhpcs.pdf?sfvrsn=0

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