Norfloxacin: restricted use in urinary infections

The European Medicines Agency (EMA) has concluded that oral fluoroquinolone norfloxacin (Utinor) shouldn't be used to treat acute or chronic, complicated pyelonephritis.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 11 December 2014

• Therapeutic area: Infectious disease, Urology and nephrology

Article date: December 2008

The EMA’s Committee for Medicinal Products for Human Use concluded that this indication should be withdrawn because efficacy has not been adequately shown for this type of infection and because the benefits of norfloxacin do not outweigh the potential risks in this indication.

Advice for healthcare professionals includes:

• oral norfloxacin should no longer be prescribed for newly diagnosed complicated pyelonephritis
• prescribers should review any patient taking oral norfloxacin for complicated pyelonephritis at their next scheduled visit, and should consider the need for alternative treatment if signs or symptoms of infection are persisting

Article citation: Drug Safety Update Dec 2008, vol 2 issue 5: 7c. 

Published 11 December 2014