FDA changes warning label on fluoroquinolones

The FDA is requiring labels and guides on fluoroquinolone antibiotics to be updated after advising their side effects can seriously harm patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options.

The agency said a safety review of the drugs associated their use with “disabling and potentially permanent serious side effects” involving tendons, muscles, joints, nerves, and the central nervous system.

“Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a ‘pins and needles’ tingling or pricking sensation, confusion and hallucinations,” the FDA statement said.

For physicians, the FDA advised stopping fluoroquinolone treatment immediately if a patient reports experiencing any of the side effects, and switching to a non-fluoroquinolone option.

Six FDA-approved brands of fluoroquinolone are currently available: Avelox, Cipro (which also comes in an extended-release form), Factive, Levaquin, Moxifloxacin Injection and Oflaxacin. The agency had issued two prior safety warning about the drugs: first in 2008 about an increased risk of tendinitis and tendon rupture, and then in 2013 on the risk of permanent nerve damage.

Despite those warnings, fluoroquinolones remain common. The Wall Street Journal cites information from drug research firm IMS Health that said a total of 36 million prescriptions for fluoroquinolones were written in 2014.