WASHINGTON -- Fluoroquinolone antibiotics, the class that includes ciprofloxacin (Cipro), should not be used to treat uncomplicated infections such as sinusitis, bronchitis, and urinary tract infections for which other drug types are effective, .
Only patients with these conditions who can't be treated with other agents should receive fluoroquinolones, the agency said.
"An FDA safety review has shown that fluoroquinolones when used systemically (i.e., tablets, capsules, and injectable) 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 FDA said.
Labels and medication guides for these agents will be updated to reflect the review's findings.
The FDA noted that it has had concerns about fluoroquinolones for these uses for many years, having included in 2008, for example.
Last year, the agency convened an advisory committee meeting to review the risk-benefit balance for fluoroquinolones. The panel agreed that the balance was unfavorable for sinusitis, bronchitis, and other common conditions for which multiple treatment options exist.