Press release 16/11/2018 Show
EMA has reviewed serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018. EMA’s human medicines committee (CHMP) has endorsed the recommendations of EMA’s safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended. The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system. Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:
Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided. The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU countries. National authorities will enforce this decision for the fluoroquinolone and quinolone medicines authorised in their countries and they will also take other appropriate measures to promote the correct use of these antibiotics. Information for patients
Information for healthcare professionals
Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Gram-positive classes. Fluoroquinolones are of value in certain infections, including some life-threatening ones, where alternative antibiotics are not sufficiently effective. The review covered medicines containing the following fluoroquinolone and quinolone antibiotics: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin. The review concerned only medicines given systemically (by mouth or injection) and inhaled medicines. More about the procedure The review of fluoroquinolones and quinolones was initiated on 9 February 2017 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC. The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. The final PRAC recommendations were adopted on 4 October 2018 and then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
How useful was this page?Add your rating ★ ★ ★ ★ ★ Who should not take quinolones?*—Because quinolones have been associated with arthropathy and chondrotoxicity in immature animals, they are not recommended for use in children and adolescents younger than 18 years of age, or in pregnant or breastfeeding women.
Who is at risk for fluoroquinolone toxicity?The U.S. Food and Drug Administration today issued a Drug Safety Communication warning health care professionals to avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with a history of blood vessel blockages or aneurysms, high ...
What is a common side effect of quinolones?Abstract. Fluoroquinolones are generally very safe antibiotics which do not cause serious or life-threatening adverse reactions. The most frequent side-effects are gastrointestinal reactions (nausea, dyspepsia, vomiting) and CNS reactions such as dizziness, insomnia and headache.
Who are fluoroquinolones contraindicated in?Contraindications to Fluoroquinolones
aeruginosa infections in patients with cystic fibrosis, prophylaxis and treatment of bacterial infections in immunocompromised patients, life-threatening multiresistant bacterial infections in neonates and infants, and Salmonella or Shigella gastrointestinal tract infections.
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