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FDA Strengthens Warning on Powerful Antibiotics

The FDA strengthened the warnings about one type of antibiotic Tuesday, saying they’re too strong to be used for non-fatal infections.
The FDA tightened warnings on fluoroquinolone drugs
The FDA tightened warnings on fluoroquinolone drugs

The Food and Drug Administration strengthened the warnings about one type of antibiotic Tuesday, saying they’re too strong to be used for sinus infections, bronchitis and simple urinary tract infections.

The drugs are in a class called fluoroquinolones and include levofloxacin (as known as Levaquin) and ciprofloxacin (Cipro). They can cause serious and sometimes permanent side-effects.

“While these drugs are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system,” the agency said in a statement.

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“These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.”

The drugs are worthwhile to use for potentially fatal infections such as plague, anthrax and some types of bacterial pneumonia but not for the more minor stuff, FDA added.

“FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive),” the statement said.

“The labeling changes include an updated Boxed Warning and revisions to the Warnings and Precautions section of the label about the risk of disabling and potentially irreversible adverse reactions that can occur together.”