In light of discrepancies noted between the current summaries of product characteristics (SmPCs) for some products and the recommendations set forth by the EMA's Pharmacovigilance Working Party (PhVWP) in April 2003, the PhVWP has revised its recommendations for the product information of selected fluoroquinolones with regard to the associated risk of QT interval prolongation.
Following a review of the safety of these broad-spectrum antibacterials, the PhVWP concluded that fluoroquinolones could be divided into three groups: those with a potential for inducing QT prolongation (gemifloxacin and moxifloxacin), those with a low potential for inducing QT prolongation (levofloxacin, norfloxacin and ofloxacin) and those either with a very low potential for inducing QT prolongation or for which there are insufficient data available to assess their risk potential (enoxacin, pefloxacin, prulifloxacin and rufloxacin).
The recommended revisions to the SmPCs and package leaflets for each of these agents are dependent upon the level of risk potential. For those substances for which there are currently insufficient data (enoxacin, pefloxacin and rufloxacin), the PhVWP is recommending that authorities in Member States encourage the marketing authorisation holders to conduct additional studies.
[Reference]
1. European Medicines Agency.Monthly report from the PhVWP December 2010 meeting. Fluoroquinolones - risk of QT interval prolongation. Internet Document: [5 pages], 6 Jan 2011. Available from: URL: http://www.ema.europa.eu. .
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