FDA Revises Boxed Warning for Certain Antibiotic Drugs
The US Food and Drug Administration (FDA) has revised the boxed warning for fluoroquinolones antibacterial drugs, which are used to treat respiratory and urinary infections in patients who have no other treatment options (https://bit.ly/2kMDRZh).
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The decision comes after a July 2016 safety alert, in which the FDA noted that fluoroquinolones may cause sudden, serious, and potentially permanent nerve damage called peripheral neuropathy. These medicines include ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. Together they are used to treat more than 20 million patients in the United States.
Peripheral neuropathy is a serious condition related to damage to the nerves that send information to and from the brain and spinal cord and the rest of the body. Damage that interrupts this connection can cause serious problems depending on which nerves are affected. In general, patients might experience numbness, tingling, burning, or shooting pain in the arms and legs.
In their safety alert, the FDA said that, “Health care professionals should not prescribe [to patietns] who have other treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks outweigh the benefits in these patients.”
They also recommend that providers, “stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.”
The use of fluoroquinolones is a complicated decision for providers. On one hand, medical conditions that require aggressive treatment can quickly get out of control when powerful antibiotics are not used. However, careless or unnecessary use of the drugs can cause devastating adverse events. As such, the FDA implores providers to educate themselves about best use and carefully monitor patients to ensure they do not demonstrate symptoms of severe complications.—Sean McGuire
