Levofloxacin - Contraindications

Contraindications

There is one contraindication now found within the 2008 package insert for Levaquin, namely that Levaquin is to be avoided in patients with a known hypersensitivity to levofloxacin or other quinolone drugs.

Caution should be exercised in prescribing to patients with liver disease.

Levofloxacin is also considered to be contraindicated in patients with epilepsy or other seizure disorders.

Pregnancy

According to the FDA approved Prescribing Information, levofloxacin is Pregnancy Category C. This designation indicates that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans but the potential benefit to the mother may in some cases outweigh the risk to the fetus. Other flouroquinolones have also been reported as being present in the mother's milk and are passed on to the nursing child.

Pediatric use

Oral and I.V. Levofloxacin is not licensed for use in the pediatric population, except as noted above, due to the risk of injury to the pediatric patient. In one study, 1534 juvenile patients (age 6 months to 16 years) treated with levofloxacin as part of three efficacy trials were followed up to assess all musculoskeletal events occurring up to 12 months post-treatment. At 12 months follow-up the cumulative incidence of musculoskeletal adverse events was 3.4%, compared to 1.8% among 893 patients treated with other antibiotics. In the levafloxacin-treated group, approximately two-thirds of these musculoskeletal AEs occurred in the first 60 days, 86% were mild, 17% were moderate, and all resolved without long-term sequelae.

In a study comparing the safety and efficacy of levofloxacin to that of azithromycin or the ceftriaxone in 712 children with community-acquired pneumonia, serious adverse events were experienced by 6% of those treated with levofloxacin and 4% of those treated with comparator antibiotics. Most of these were considered by the treating physician to be unrelated or doubtfully related to the study drug. Two deaths were observed in the levofloxacin group, neither of which was thought to be treatment-related. Spontaneous reports to the FDA Adverse Effects Reporting System at the time of the September 20, 2011 FDA Pediatric Drugs Advisory Committee include musculoskeletal events (39, including 5 cases of tendon rupture) and CNS events (19, including 5 cases of seizures) as the most common spontaneous reports between April 2005 and March 2008. An estimated 130,000 pediatric prescriptions for levofloxacin were filled on behalf of 112,000 pediatric patients during that period.