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EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics


Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) started a review of systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. These side effects have already been known, and have been included in the product information for these medicines.

The review is at the request of the German medicines authority (BfArM) following reports of long-lasting side effects in the national safety database and the published literature. There has been no previous EU-wide review specifically focusing on the persistence of these side effects.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now evaluate all available data and determine whether there is a need to introduce new measures to minimise these risks or modify how the medicines are used.
Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections. Healthcare professionals using these medicines should continue to follow the official prescribing information. Patients who have any questions about their treatment should speak to their doctor.

More about the medicines

Quinolones and fluoroquinolones are a class of broad spectrum antibiotics that are active against so‑called Gram-negative and Gram-positive bacteria.

The review covers the following medicines: cinoxacin, ciprofloxacin, enoxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.

The review concerns only inhaled medicines and medicines given systemically (by mouth or injection). Topical medicines, such as those applied directly to the skin, eyes or ears, are not included.

More about the procedure

The review of quinolone and fluoroquinolone antibiotics was initiated at the request of German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.

The review will be carried out by PRAC, the Committee responsible for the evaluation of safety issues for human medicines, which will issue recommendations. The PRAC recommendations will then be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. CHMP's opinion will be sent to the European Commission for the adoption of a legally binding decision applicable in all EU Member States.