Source: Medicines & Healthcare Products & Regulatory Agency (MHRA)
Summary
On the 21st of March, MHRA issued an alert in regards to the following Fluoroquinolone Antibiotics: ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin. The alert aims to inform the new restrictions and precautions due to very rare reports of disabling and potentially long-lasting or irreversible side effects.
Rare reports of long-lasting or irreversible side effects
- Disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal (including tendinitis and tendon rupture) and nervous systems have been reported with fluoroquinolone antibiotics- see Drug Safety Update for more information.
- Prescribers and dispensers of fluoroquinolone should advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice- see MHRA sheet to discuss measures with patients.
- Fuoroquinolone treatment should be discontinued at the first sign of tendon pain or inflammation in patients and the affected limb or limbs appropriately treated (For example, with immobilisation)
- Avoid coadministration with corticosteroids since this could exacerbate fluoroquinolone-induced tendinitis and tendon rupture
- Avoid use in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic.
- Prescribe with special caution in people older than 60 years and for those with renal impairment or solid-organ transplants because they are at a higher risk of tendon injury.
Warnings for when fluoroquinolone should not be prescribed
- Non-severe or self-limiting infections or non-bacterial conditions
- Mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease) unless other antibiotics that are commonly recommended for these infections are considered inappropriate.*
- Uncomplicated cystitis (for which ciprofloxacin or levofloxacin were previously authorised) unless other antibiotics that are commonly recommended are considered inappropriate*
*For example, when first-time antibiotics are unsuitable due to resistance, contraindications, or intolerance, or if first-line treatments have failed.
» Click here to read the full CAS alert