Levaquin (levofloxacin) is an antibiotic that is part of a class of antibiotics known as fluoroquinolones. Other antibiotics in this class include Cipro (ciprofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), Floxin (ofloxacin), and Factive (gemifloxacin).
In July 2008, the FDA added a Box Warned for these antibiotics due to the increased risk of tendinitis and tendon rupture. In 2013, the FDA began requiring drug labels and Medication Guides to better describe another crippling side effect: peripheral neuropathy (nerve damage). Peripheral neuropathy often presents in a patient's arms, hands, legs, and/or feet, and symptoms may include burning, tingling, change in sensation, change in temperature, numbness, and/or weakness. These symptoms are often completely disabling and may last for several months but, for some patients, they may be permanent.
In May 2013, the FDA issued a News Release and reported that, "An FDA safety review has shown that fluoroquinolones when used systemically are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system." The News Release further noted, "The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections...".
In July 2016, the FDA issued another News Release and again reported that fluoroquinolones should be reserved for use in patients who have no alternative treatment options.
- Despite FDA warnings, doctors and hospitals continue to prescribe these antibiotics for patients being treated for illnesses such as sinusitis, bronchitis, and urinary tract infections.