Gatifloxacin

Observational studies

Oral gatifloxacin has been evaluated in 108 patients with neutropenia aged 3–21 years [ ]. There were adverse events in 11, including electrocardiographic changes (5%), diarrhea (3.5%), increased liver enzymes (2%), vomiting (1.5%), and arthralgia (0.5%).

Comparative studies

In a double-blind, randomized study in 102 adult women who took either gatifloxacin 400 mg as a single dose or 200 mg/day for 3 days or ciprofloxacin 250 mg bd for 3 days, the frequencies of treatment-related adverse events were 17%, 19%, and 14% respectively [ ]. The most common adverse effects were nausea (4.6%, 5.4%, and 5.0%), headache (1.9%, 1.9%, and 1.4%), dizziness (2.2%, 1.3%, and 1.4%), and diarrhea (1.1%, <1%, and 1.4%).

Cardiovascular

Although early studies suggested that gatifloxacin has little effect on the QT interval of the electrocardiogram [ , ], clinical trial data and data from phase IV studies have shown that it prolongs the QT interval [ ]. Four cases of gatifloxacin-associated cardiac toxicity have been reported in patients with known risk factors for this adverse event [ ].

• A 95-year-old woman took gatifloxacin and developed recurrent episodes of torsade de pointes on the 4th day of treatment and one hour after infusion [ ].

Nervous system

In patients taking gatifloxacin there have been reports of myoclonus and generalized seizures [ ] and ataxia and generalized seizures [ ]. Status epilepticus has been attributed to gatifloxacin 400 mg/day in a 79-year-old woman with a non-febrile urinary tract infection with Escherichia coli [ ].

Two elderly patients with histories of convulsions developed generalized status epilepticus treatment during with oral gatifloxacin [ ].

Of five patients who developed suspected drug-induced aseptic meningitis, one had been treated for Salmonella gastroenteritis with ciprofloxacin [ ]. Symptoms of nervous system disease, including psychomotor excitement and deterioration of auto and allopsychical orientation, occurred after 4 days. She had a concomitant urticarial rash and considerable swelling of the face. Ciprofloxacin was immediately withdrawn and her symptoms improved.

Sensory systems

In phase III trials of gatifloxacin, the most frequently reported adverse events were conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis, which occurred in 5–10% of patients with bacterial conjunctivitis [ ]. Chemosis, conjunctival hemorrhage, dry eyes, discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity, and taste disturbance were reported by 1–4% of patients. Treatment-related adverse events were reported by 3.8% of those who took twice-daily doses and 1.9% of those who took doses four times a day.

Gatifloxacin can cause intrastromal macroscopic crystalline deposits through a compromised corneal epithelium.

• An 85-year-old man developed faint crystal-like white precipitates in the mid-peripheral stroma of his left cornea 3 weeks after starting to use 0.3% gatifloxacin eye-drops [ ].

• A 30-year-old man developed a corneal perforation after using gatifloxacin for an inflamed pterygium [ ]. The corneal perforation may have been caused by a combination of corneal thinning and dellen formation secondary to the inflamed pterygium, since fluoroquinolones affect keratocytes.