FDA Drug Safety Communication: FDA requires label
changes to warn of risk for possibly permanent nerve damage from
antibacterial fluoroquinolone drugs taken by mouth or by injection
View and print full Drug Safety Communication (PDF - 118KB)
Safety Announcement
[8-15-2013] The
U.S. Food and Drug Administration (FDA) has required the drug labels
and Medication Guides for all fluoroquinolone antibacterial drugs be
updated to better describe the serious side effect of peripheral
neuropathy. This serious nerve damage potentially caused by
fluoroquinolones (see Table for a list) may occur soon after these drugs
are taken and may be permanent.
The risk of peripheral neuropathy
occurs only with fluoroquinolones that are taken by mouth or by
injection. Approved fluoroquinolone drugs include levofloxacin
(Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin
(Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical
formulations of fluoroquinolones, applied to the ears or eyes, are not
known to be associated with this risk.
If a patient develops
symptoms of peripheral neuropathy, the fluoroquinolone should be
stopped, and the patient should be switched to another,
non-fluoroquinolone antibacterial drug, unless the benefit of continued
treatment with a fluoroquinolone outweighs the risk. Peripheral
neuropathy is a nerve disorder occurring in the arms or legs. Symptoms
include pain, burning, tingling, numbness, weakness, or a change in
sensation to light touch, pain or temperature, or the sense of body
position. It can occur at any time during treatment with
fluoroquinolones and can last for months to years after the drug is
stopped or be permanent. Patients using fluoroquinolones who develop
any symptoms of peripheral neuropathy should tell their health care
professionals right away.
FDA will continue to evaluate the safety
of drugs in the fluoroquinolone class and will communicate with the
public again if additional information becomes available.
Contact FDA
1-800-332-1088
1-800-FDA-0178 Fax
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