EMA committee recommends restrictions on use of quinolone and fluoroquinolone

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A European Medicines Agency (EMA) committee has recommended that the use of fluoroquinolone and quinolone antibiotics should be restricted following a review of their disabling and potentially long-lasting side effects.

The Pharmacovigilance Risk Assessment Committee (PRAC) considered first-hand accounts of patients’ experiences of using the drugs, which were given at the EMA’s second ever public hearing on medicine usage in June 2018, before producing its recommendation on 5 October 2018.

The PRAC said that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market. It also recommended that remaining fluoroquinolone antibiotics should not be used to treat minor infections and should be used with caution, particularly in older people, patients with kidney problems, patients who have had an organ transplant, and patients who are being treated with a systemic corticosteroid.

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. Reported disabling side effects mainly involved muscles, tendons, bones and the nervous system.

Last updated
The Pharmaceutical Journal, EMA committee recommends restrictions on use of quinolone and fluoroquinolone;Online:DOI:10.1211/PJ.2018.20205578

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