The labels will also state that these agents should be reserved for patients “who have no other treatment options” for treating acute bacterial sinusitis, bronchitis, or urinary tract infections, “because the risk. generally outweighs the benefits in these patients”.
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The drugs are in a class called fluoroquinolones and include levofloxacin (as known as Levaquin) and ciprofloxacin (Cipro).
Because of this, the FDA recommends reserving these antibiotics for serious bacterial infections, such as anthrax, plague and bacterial pneumonia.
“Fluoroquinolones have risks and benefits that should be considered very carefully”, Dr. Edward Cox said in an FDA news release. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use”. Other warnings on the labeling include risks of peripheral neuropathy, CNS effects (eg, psychosis, anxiety, insomnia, depression), and cardiac (eg, QT prolongation), dermatologic, and hypersensitivity reactions. If a patient experiences serious side effects while taking fluoroquinolones, treatment should be immediately discontinued and switched to a non-fluoroquinolone antibacterial to complete the treatment course. The Medication Guide describes the safety issues associated with these drugs and should be given to the patient with each prescription.
These drugs should no longer be prescribed for run-of-the-mill bacterial infections of the sinus, throat, and urinary tract unless there is no other option.
The FDA added a box warning to the antibiotics in July 2008 to inform users about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed.
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Nearly three years later, the FDA warned that the drugs could worsen symptoms of the neuromuscular disease myasthenia gravis. The agency says use should be restricted to only the most acute illnesses where there are no other options. The drug safety communication also announced the required labeling updates to reflect this new safety information. He’s director of the Office of Antimicrobial Products at the FDA’s Center for Drug Evaluation and Research.
