EMEA recommends restricted use of oral norfloxacin-containing medicines in urinary infections

25 July 2008
The European Medicines Agency has recommended restricting the use of oral norfloxacin-containing medicines in urinary infections.

The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for oral norfloxacin-containing medicines for the treatment of acute or chronic complicated pyelonephritis (a type of kidney infection) should be withdrawn because the benefits of these medicines do not outweigh their risks in this indication.

This is based on the fact that the efficacy has not been adequately demonstrated for this type of infection.

Norfloxacin is a broad-spectrum antibiotic (a fluoroquinolone). The medicine is authorised in all European Union Member States under various trade names for the treatment of infections, including simple or complicated urinary tract infections, infection of the prostate, uncomplicated gonorrhoea, several types of gastroenteritis and conjunctivitis.

The CHMP review of norfloxacin medicines was initiated on the request of the Belgian medicines regulatory agency, which questioned the efficacy of oral formulations of the medicine for complicated pyelonephritis in comparison with other fluoroquinolones. In current practice, this disease is usually treated using either injectable antibiotics, or other fluoroquinolones taken by mouth or given by injection.

Following evaluation of information provided by the companies, the CHMP, at its July 2008 meeting, noted that there was not enough clinical data to demonstrate the efficacy of oral treatment with norfloxacin-containing medicines in complicated pyelonephritis. Therefore, the CHMP concluded that the use of oral norfloxacin-containing medicines in the treatment of acute or chronic complicated pyelonephritis could no longer be supported.

The recommendation of the CHMP has no impact on the use of oral norfloxacin-containing medicines in other types of infection.

Doctors should not prescribe oral norfloxacin for complicated pyelonephritis and should consider switching patients already taking oral norfloxacin for this type of infection to an alternative antibiotic

Patients who are taking oral formulations of norfloxacin-containing medicines to treat complicated pyelonephritis should discuss their treatment with their doctor if they continue to have symptoms or at their next scheduled visit.

You can download the EMEA press release and questions and answers to oral norfloxacin-containing medicines in the factbox to the right.

For further information, please contact Chief Medical Officer Marianne Orholm, tel. +45 4488 9740.

Danish Medicines Agency, 24 July 2008