Levofloxacin: some indications restricted
- Medicines and Healthcare products Regulatory Agency
- 25 September 2012
- Therapeutic area:
- Dentistry, Dermatology, Infectious disease, and Respiratory disease and allergy
Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.
Article date: September 2012
Levofloxacin (a fluoroquinolone antibiotic) may only be considered in the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia or complicated skin and soft tissue infections when other medicines cannot be prescribed, or have been ineffective.
This restriction resulted from a review of overall efficacy and safety data, which suggested that the safety profile of levofloxacin was unfavourable as first-line treatment for these indications. The risks contributing to this assessment included serious hepatotoxicity, cardiac arrhythmia, severe skin reactions and tendon rupture.
Other licensed indications for oral and intravenous levofloxacin remain unchanged.
Product information for all levofloxacin products will be updated with the recommendations. Official guidance on the appropriate use of antibiotics and the prevalence of resistance (such as NICE guidance) should be considered when prescribing levofloxacin.
BNF section 5.1: Antibacterial drugs
Article citation: Drug Safety Update September 2012, vol 6, issue 2: S2
Published: 25 September 2012