Revised SPC: Ciproxin (ciprofloxacin) 250 mg/5 mL granules and solvent for oral suspension
Several sections of the summary of product characteristics (SPC) have been modified to highlight the possible risk of prolonged, disabling and potentially irreversible serious adverse drug reactions.
Source:
electronic Medicines compendium
SPS commentary:
Recently, the MHRA issued a safety alert reminding healthcare professionals prescribing fluoroquinolone antibiotics to be alert to the risk of disabling and potentially long-lasting or irreversible side effects. Fluoroquinolones should not be prescribed for non-severe or self-limiting infections, or for 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. Fluoroquinolone treatment should be discontinued at the first signs of a serious adverse reaction, including tendon pain or inflammation.