Another Warning About Fluoroquinolone Antibiotics

FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

This information is an update to the FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together issued on May 12, 2016

Some signs and symptoms of serious side effects include:

  • unusual joint or tendon pain,
  • muscle weakness,
  • a “pins and needles” tingling or pricking sensation,
  • numbness in the arms or legs,
  • confusion, and
  • hallucinations.

Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options

Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis.

The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects.

Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions.

After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible,

FDA evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone.

We evaluated only reports submitted to FDA, so there are likely additional cases of which we are unaware.

The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time we received the reports, the side effects had continued for an average of 14 months to as long as 9 years after stopping the medicines.

Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.

Here’s a list of the drugs by name:

  • ciprofloxacin (marketed as Cipro and generic ciprofloxacin),
  • ciprofloxacin extended-release (marketed as Cipro XR and Proquin XR),
  • gemifloxacin (marketed as Factive),
  • levofloxacin (marketed as Levaquin),
  • moxifloxacin (marketed as Avelox),
  • norfloxacin (marketed as Noroxin), and
  • ofloxacin (marketed as Floxin)

Here are two more FDA documents about this antibiotic:

 

This is the fifth warning about these antibiotics that I’ve posted since 2013:

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