The U.S. Food and Drug Administration (FDA) has approved new safety labeling
changes for a class of antibiotics called fluoroquinolones in order to
enhance existing warnings about their link with a number of serious and
potentially permanent side effects. The purpose of these antibiotics is
to treat bacterial infection by killing bacteria or stopping its growth.
While effective in this capacity, many people have reported that both
the injectable and oral versions of the drug have caused severe side effects
related to the central nervous system, muscles, joints, and tendons. These
effects can manifest either hours or weeks after exposure, and could cause
FDA-approved fluoroquinolones include gemifloxacin (Factive), ofloxacin,
moxifloxacin (Avelox), ciprofloxacin (Cipro), ciprofloxacin extended-release
tablets, and levofloxacin (Levaquin). The labeling changes include an
updated Boxed Warning as well as revisions to the Warnings and Precautions
section, which includes information about the risk of the aforementioned
disabling and potentially irreversible side effects. The label also contains
new limitation-of-use statements advising doctors to reserve this class
of antibiotics only for patients who have no other options for treatment
for the following conditions:
- Uncomplicated urinary tract infections
- Acute exacerbation of chronic bronchitis
- Acute bacterial sinusitis
The FDA has determined that the risk of complications far outweighs the
benefits of this drug for patients with these conditions. The FDA thus
advises that doctors only prescribe this medication as a last resort for
these patients when no other treatment options are available. However,
for patients with certain serious bacterial infections, including bacterial
pneumonia, plague, and anthrax, fluoroquinolones are still approved as
an appropriate therapeutic option.
Visit the FDA website to view the full press release:
FDA updates warnings for fluoroquinolone antibiotics.
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If you have suffered serious or permanent injury after taking a fluoroquinolone
drug, you should consult with an Orlando dangerous drug attorney at The
Maher Law Firm. Recommended by clients for more than 40 years, our firm
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