FDA Enhances Warnings on Fluoroquinolone Antibiotics

warning pills
Science & Medicine

On July 26, the U.S. Food and Drug Administration (FDA) bolstered the warnings concerning a certain class of antibiotics, called fluoroquinolones, saying they’re too strong for bronchitis, sinus infections, and simple urinary tract infections.

Levofloxacin (brand name Levaquin) and ciprofloxacin (brand name Cipro) are both examples of commonly prescribed fluoroquinolones. These drugs are associated with serious and long-lasting side effects. A good friend of mine suffers from permanent neuropathy in her hands as a result of taking Cipro several years ago.

The FDA said in a statement:

“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.

These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.” [1]

Two or more of these side effects can occur together. [2]

Fluoroquinolone injuries are so common, in fact, that victims of the antibiotics refer to themselves as “floxies.” The name comes from ciprofloxacin.

Source: Floxie Hope

The agency stated that fluoroquinolones should only be used for serious bacterial infections, such as anthrax, plague, and bacterial pneumonia. In such cases, the FDA said that:

“the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option.”

The new labeling action will include an updated boxed (“black box”) warning and revisions to the Warnings and Precautions section of the label. Patients who purchase one of these antibiotics will also receive a medication guide describing the safety issues associated with fluoroquinolones.

The FDA first slapped a boxed warning on fluoroquinolones in July 2008 to inform consumers that the drugs have the potential to cause tendinitis – inflammation of the tissues that connect muscles to bones. [3]

Three years later (2011), the FDA warned that fluoroquinolones could exacerbate symptoms of the neuromuscular disease myasthenia gravis. In 2013, the agency detailed the potential for serious nerve damage – irreversible peripheral neuropathy, like my friend has. [2]

Then, in 2015, an FDA advisory committee said that uncomplicated sinus, urinary, and bronchial infections should be treated using other options.


[1] NBC News

[2] WebMD

[3] Reuters

Floxie Hope

(Article featured image only a representation of fluoroquinolones.)