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EMA panel recommends restricting certain broad-spectrum antibiotics


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EMA panel recommends restricting certain broad-spectrum antibiotics

A European Medicines Agency panel has recommended restricting the use of a class of antibiotics called fluoroquinolones, and has recommended removing quinolone antibiotics from the market entirely, due to potentially long-lasting and disabling side effects.

The agency's Pharmacovigilance Risk Assessment Committee issued the Oct. 5 ruling on fluoroquinolone and quinolone antibiotics taken by mouth, injection or inhalation, following a review initiated in 2017. Quinolone and fluoroquinolones are a class of antibiotics approved to treat or prevent certain bacterial infections. The review covered fluoroquinolone antibiotics such as ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin as well as quinolone antibiotics including cinoxacin, nalidixic acid, pipemidic acid.

The committee recommended removing medicines that contain a quinolone antibiotic from the market because they are only authorized for infections that should no longer be treated with this particular class of antibiotics.

As for fluoroquinolone antibiotics, the committee recommended that the medicines not be used to treat infections that might get better without treatment or are not severe; for traveler's diarrhea or recurring urine infections; for patients who have previously had adverse reactions to a fluoroquinolone or quinolone medicine; or to treat mild or moderately severe infections except in instances when other antibacterial medicines cannot be used.

The committee said the medicines have on rare occasions caused disabling side effects, mainly involving muscles, tendons and bones, and the nervous system.

Some of the companies selling medicines containing these antibiotics in the European Union include Bayer AG, Pfizer Inc., Sanofi, Novartis AG's generic unit Sandoz Inc., Fresenius Kabi AG, Teva Pharmaceutical Industries Ltd and Mylan NV.

The regulator also advised caution on using the drugs in elderly patients who have kidney problems, underwent an organ transplantation or those being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury, EMA said, adding that the doctors should stop treatment with the drugs at the first sign of potential side effects.

The committee's ruling comes after the U.S. Food and Drug Administration in July directed the makers of fluoroquinolone antibiotics to update their safety labels with strengthened warnings about potential mental health side effects and serious blood sugar disturbances.

The panel's recommendations will now be sent to the agency's Committee for Medicinal Products for Human Use for adoption. The European Commission will then take into account the EMA ruling and issue a legally binding decision, which could restrict the use of these drugs in all EU nations.