MHRA issues safety update on fluoroquinolone antibiotics

The MHRA has issued a new Drug Safety Update on the use of fluoroquinolone antibiotics (including ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin), following reports of rare but disabling side-effects and new restricted indications for these medicines.

The MHRA advises that systemic fluoroquinolones can very rarely cause long-lasting, disabling and potentially irreversible side-effects mainly affecting the musculoskeletal and nervous systems. Therefore, patients should be advised to stop treatment and contact their doctor immediately at the first signs of a serious adverse reaction, eg tendinitis or tendon rupture, muscle pain or weakness, joint pain or swelling, peripheral neuropathy or CNS effects.

The use of fluoroquinolones should be reserved for serious or life-threatening bacterial infections, and the MHRA warns that they should not be prescribed for non-severe, self-limiting or non-bacterial infections, or for some mild to moderate infections (eg acute exacerbation of chronic bronchitis or COPD) unless other recommended antibiotics are inappropriate. The MHRA adds that ciprofloxacin and levofloxacin should no longer be prescribed for uncomplicated cystitis unless no other recommended antibiotics are suitable. Fluoroquinolones should be avoided in patients who have previously had a serious adverse reaction to a quinolone or fluoroquinolone and should be prescribed with caution in people older than 60 years and in those with renal impairment or solid-organ transplants. Concomitant use with a corticosteroid should also be avoided.

Following an EU-wide safety review, the indications for fluoroquinolone and quinolone antibiotics have now been restricted by the EMA, and prescribers should refer to the updated summaries of product characteristics (SmPCs) for full details before prescribing them. The quinolone antibiotic nalidixic acid was previously authorised for use in urinary tract infections, which is no longer a permitted indication, and therefore the licence for this antibiotic has been cancelled.

The MHRA requests prescribers to continue reporting any suspected adverse drug reactions associated with fluoroquinolones via the Yellow Card Scheme, while it continues to monitor the benefits and risks of these antibiotics.


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