The marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid and pipemidic acid should be suspended and the use of the remaining fluoroquinolone antibiotics restricted, the European Medicines Agency’s (EMA) has concluded following a 21-month review.
The decision by the Committee for Medicinal Products for Human Use (CHMP) was an endorsement of recommendations made by the EMA’s Pharmacovigilance Risk Assessment Committee in October 2018. Both committees acknowledged that the drugs can cause disabling and potentially permanent side effects.
Restrictions on the use of fluoroquinolone antibiotics will mean they should not be used: to treat infections that might get better without treatment or are not severe; to treat non-bacterial infections; for preventing traveller’s diarrhoea or recurring lower urinary tract infections; or to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally-binding decision applicable to all countries in the European Union.
The EMA’s review of this class of antibiotics began in February 2017 at the request of the Federal Institute for Drugs and Medical Devices, the medical regulatory body in Germany, following reports of long-lasting side effects in its national database and published literature.