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MHRA strengthens restrictions on fluoroquinolone antibiotics

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Patients are advised to discontinue use of fluoroquinolones at the first signs of a serious adverse reaction

Britain’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced that fluoroquinolone antibiotics must only be administered when no other antibiotics are appropriate for use.

It elaborated that fluoroquinolones given systemically (by mouth, injection, or inhalation) should only be prescribed “when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient.”

Previous regulations on fluoroquinolones stated that this class of antibiotics should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions.

Further restrictions have been introduced after receiving reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, the MHRA revealed.

Dr Alison Cave, MHRA Chief Safety Officer, said: “Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.

“We recognise fully the importance of limiting the use of these medicines.

“That’s why, from today, fluoroquinolones should only be prescribed when usage of other antibiotics is inappropriate. Fluoroquinolones use should be discontinued at the first signs of a serious adverse reaction,” she added.

Dr Cave encourages patients using fluoroquinolone antibiotics to seek immediate medical help if they experience any adverse reactions.

Serious side effects associated with use of fluoroquinolone antibiotics include tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects.

Patients can report any suspected adverse reactions to fluoroquinolones via the MHRA’s Yellow Card scheme.

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