Black Box Warning

WARNING: TENDINITIS AND TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including gemifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Discontinue gemifloxacin at the first sign of tendon pain, swelling, or inflammation. Avoid gemifloxacin in patients with a history of fluoroquinolone-associated tendinitis or tendon rupture. Fluoroquinolones can cause peripheral neuropathy which may be permanent. Discontinue gemifloxacin at the first sign or symptom of peripheral neuropathy such as pain, burning, tingling, numbness, or weakness. Serious and sometimes fatal central nervous system (CNS) reactions such as seizures, increased intracranial pressure, toxic psychosis, delirium, hallucinations, paranoia, depression, nightmares, anxiety, insomnia, tremors, and suicidal thoughts or actions have been reported with fluoroquinolone use. Discontinue gemifloxacin at the first sign or symptom of any CNS adverse reaction. Fluoroquinolones should be used with caution in patients with CNS disorders or a history of seizures. Fluoroquinolones can exacerbate muscle weakness in persons with myasthenia gravis. Avoid gemifloxacin in patients with known history of myasthenia gravis.