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August 15, 2013: FDA Demands Label Change to Address Levaquin Nerve Damage Risk

Levaquin Nerve Damage News

On August 15, 2013, The U.S. Food and Drug Administration (FDA) took action to address the risk of peripheral neuropathy, a type of nerve damage associated with the use of fluoroquinolone antibiotics like Levaquin. The FDA has ordered the manufacturers of these fluoroquinolone antibiotics to update the drugs’ labeling in order to better explain the risk of serious nerve damage. This dangerous side effect may occur soon after these drugs are taken and may be permanent.


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Levaquin Nerve Damage Information

Peripheral neuropathy is nerve damage in the arms or legs.

Symptoms caused by Levaquin nerve damage may include:
• pain,
• burning,
• tingling,
• numbness,
• weakness,
• a change in sensation to light touch, pain, temperature, or sense of body position

No specific risk factors have been identified for the development of peripheral neuropathy, as the likelihood of experiencing the side affect seems to be unrelated to the age of the patient or the duration of therapy.

Only fluoroquinolones that are taken by mouth or by injection pose a risk of nerve damage.

Affected fluoroquinolone antibiotics include:
• levofloxacin (Levaquin),
• ciprofloxacin (Cipro),
• moxifloxacin (Avelox), norfloxacin (Noroxin),
• ofloxacin (Floxin),
• gemifloxacin (Factive).

Levaquin Nerve Damage Label Change

Even after nerve damage was added to the “Warnings and Precautions” sections of Levaquin (and other fluoroquinolone) labeling in 2004, the FDA continued to receive reports of peripheral neuropathy. As a result, the FDA has now required drug manufacturers to revise the drug labels and Medication Guides for their fluoroquinolone antibiotics. “These label changes are to better characterize the risk of peripheral neuropathy associated with this class of systemic fluoroquinolones,” explained the FDA in a Safety Communication.

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