According to a 2013 Drug and Safety Warning, the U.S. Food and Drug Administration, or FDA, has since required a label update for all fluoroquinolone drugs to include a warning to consumers about the risk of nerve damage (or peripheral neuropathy) when taking any product from this class of drugs.

The six most commonly prescribed and used quinolone antibiotic drugs used within the United States that have been affected by the FDA labeling mandate include Cipro, Levaquin, Avelox, Norxin, Floxin, and Factive.

It is important to note that this quinolone peripheral neuropathy warning only applies to oral or injectable fluoroquinolones, not eye drop or ear drop versions of these antibiotic drugs.

While it is true that fluoroquinolone peripheral neuropathy is a fairly rare condition, the FDA saw it fit to include a label warning on this class of drugs because millions of patients take quinolone drugs each and every year.

Peripheral neuropathy is a form of nerve damage in which a patient experiences pain and tingling in the hands, arms, feet, and legs. This condition may also lead to muscle weakness and loss of sensation and/numbness.

The resulting quinolone nerve damage may be permanent and usually manifests a few hours to a few days from the start of the antibiotic treatment. However, unlike other drug side effects, quinolone side effects like nerve damage will not necessarily go away just by discontinuing the drug treatment.

Quinolone Peripheral Neuropathy Symptoms and Signs

Quinolone peripheral neuropathy side effects have been known as a possible drug complication for quite a few years. In the fine print of the professional packaging (also known as the package insert), a quinolone nerve damage risk warning has been included since 2004.

However, most patients prescribed a round of quinolone antibiotics do not normally receive a drug’s package insert, meaning that until after the 2013 FDA drug labeling requirement, most consumers were unware of this serious quinolone antibiotic side effect.

Furthermore, shortly after releasing the quinolone peripheral neuropathy labeling change and warning, the FDA reviewed their Adverse Event Reporting System (AERS) with special attention given to the reported cases of fluoroquinolone peripheral neuropathy which resulted in patient disability between Jan. 1, 2003 and Aug. 1, 2012.

According to the FDA AERS review, the data showed a continued high association disabling peripheral neuropathy and consumer use of fluoroquinolone.

There are various signs of nerve damage that a patient may exhibit shortly after taking a quinolone antibiotic. Should a consumer experience any of the quinolone side effects listed below, they should cease taking the fluoroquinolone prescription medication immediately in order to reduce the risk of permanent nerve damage, and they should also contact their attending physician.

Some signs of quinolone peripheral neuropathy side effects include:

• Tingling or numbness in the extremities starting in the hands and feet and spreading to the arms and legs
• Burning pain
• Sharp, jabbing pain or electric-like pain
• Extreme touch sensitivity
• Skin, hair or nail changes
• Lack of coordination
• Muscle weakness
• Paralysis
• Heat intolerance
• Bowel, bladder of digestive problems
• Dizziness or lightheadedness

Many individuals and family members of individuals who have allegedly suffered from severe nerve damage from a quinolone drug have filed quinolone peripheral neuropathy lawsuits or joined quinolone peripheral neuropathy class action lawsuits.