EMA Suspends Authorizations of Quinolone and Fluoroquinolone Antibiotics

Pharmaceutical Technology Editors

After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.

The European Medicines Agency announced on Nov. 16, 2018 that it is suspending marketing authorization of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid and restricting use of remaining fluoroquinolone antibiotics after a review of serious and potentially permanent side effects. 

According to EMA’s human medicines committee (CHMP), prescribing information will include the potential serious side effects. Patients will be advised to stop using the antibiotic if side effects involving muscles, tendons, joints, or the nervous system occur.

CHMP is restricting the use of fluoroquinolone antibiotics. They should not be used to treat infections that are not severe, non-bacterial infections, reoccurring lower urinary tract infections, or mild or moderate bacterial infections that can be treated by other antibiotics, or to prevent traveler’s diarrhea. Fluoroquinolones, according to EMA, should be avoided in patients with previous occurrences of side effects, and special caution should be used when treating elderly patients or those with kidney disease.

Source: EMA