FDA ADDS LABEL WARNINGS FOR FLUOROQUINOLONE ANTIBIOTICS

The U.S. Food and Drug Administration has approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.  An earlier warning from the FDA about serious musculoskeletal complications from fluoroquinolone antibiotics will now be included in the drugs’ labels.

The FDA is strengthening its warning about the popular class of antibiotics because they may cause sudden, serious, and potential permanent nerve damage called peripheral neuropathy.  This is damage to the nerves that send information to and from the brain and spinal cord and the rest of the body.  Damage interrupts this connection, and the symptoms depend on which nerves are affected.  Peripheral neuropathy has been listed as a side effect of fluoroquinolones since 2004.  There have been reports of long-lasting nerve damage and disability in patients taking this type of medication.

Fluoroquinolones are antibiotics that are commonly used to treat a variety of illnesses such as respiratory and urinary tract infections.  These medicines include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin).  More than 23 million patients received a prescription for one of them in 2011.

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 who have other treatment options.  The FDA has determined that fluoroquinolones should be reserved for those who do not have alternative treatment options.

Patients are advised to contact their health care professional immediately if they experience any serious side effects while taking their fluoroquinolone medicine.  Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling sensation, confusion and hallucinations.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.  “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.”