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Drug-Induced Peripheral Neuropathy from the Fluoroquinolone Antibiotics

January 2005

FDA New Labeling Requirements

The Food and Drug Administration (FDA) now requires that the professional product labeling, or package inserts, for all fluoroquinolone antibiotics must warn about the possibility of peripheral neuropathy (nerve damage).

A list of the fluoroquinolone antibiotics currently available in the U.S. appears at the end of this article.

Peripheral neuropathy describes damage to the peripheral nervous system, the communications network that transmits information concerning movement from the brain and spinal cord (the central nervous system) to every other part of the body. Peripheral nerves also send sensory information – such as a message that the feet are cold or a finger is burned – back to the brain and spinal cord. Damage to the peripheral nervous system interferes with these vital motor and sensory connections.

The text of the new warning reads:

Warnings

Peripheral Neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias (abnormal sensation) and weakness have been reported in patients receiving quinolones, including [name of fluoroquinolone antibiotic]. [Name of fluoroquinolone antibiotic] should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibration sensation, and/or motor strength in order to prevent the development of an irreversible condition.

What You Can Do

If you are taking a fluoroquinolone antibiotic and experience pain, burning, tingling, numbness, and weakness or both, or have problems with light touch, pain, temperature, position sense, vibratory sensation, and or motor strength or both you should stop the medication immediately and contact your physician.
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