PRAC Recommends Restrictions on Fluoroquinolone, Quinolones

Megan Brooks


October 05, 2018

The European Medicine Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of systemic and inhaled fluoroquinolone and quinolone antibiotics following a safety review.

"Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons, and bones, and the nervous system," the EMA said in a news release.

The PRAC also advised that some medicines, including all those that contain a quinolone antibiotic, be removed from the market.

The PRAC recommended that the remaining fluoroquinolone antibiotics should not be used to treat infections that might improve without treatment or are not severe (such as throat infections); to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic; or to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used. 

They should also not be used to prevent traveler's diarrhea or recurring lower urinary tract infections.

The PRAC further recommended that fluoroquinolone antibiotics be used with caution in the elderly, patients with kidney problems, patients who have had an organ transplantation, or those who are being treated with a systemic corticosteroid, as these patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.

The PRAC recommends that healthcare providers advise patients to stop taking a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons, or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).

The PRAC safety review was announced in early 2017, as reported by Medscape Medical News, and covered the fluoroquinolone antibiotics ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, and rufloxacin; and the quinolone antibiotics cinoxacin, nalidixic acid, and pipemidic acid.

In 2016, the US Food and Drug Administration (FDA) enhanced warnings about the link between fluoroquinolones and disabling and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system. 

In July, the FDA ordered label changes for fluoroquinolones to strengthen warnings about the antibiotics' risks for mental health side effects and serious blood sugar disturbances, as reported by Medscape Medical News

The PRAC recommendations will now be sent to EMA's Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency's final opinion.

The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU member states. The new restrictions on the use of fluoroquinolones and quinolones will become applicable after a Commission decision is issued.

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