Use of levofloxacin for the following indications has been restricted to cases where other medicines cannot be prescribed or have been ineffective:
- treatment of acute bacterial sinusitis;
- acute exacerbation of chronic bronchitis;
- community acquired pneumonia;
- complicated skin and soft tissue infections.
Safety concerns
The MHRA decision to limit use of the quinolone antibiotic was based on data indicating an unfavourable safety profile associated with its use as first-line treatment in these conditions. Specified risks include serious hepatotoxicity, cardiac arrhythmia, severe skin reactions and tendon rupture.
Other indications unaffected
Other licensed indications for both oral and parenteral forms of the drug, including UTI and chronic bacterial prostatitis, are unaffected by the change.