Among the most widely used antibiotics in the United States are fluoroquinolones, which include Levaquin, Cipro, Avelox, Noroxin, Floxin and Factive. This class of drugs has been linked to variety of issues, including risks of peripheral neuropathy, tendon ruptures, and liver and kidney problems. Now doctors want the warning labels updated to add potential psychiatric problems.

A citizen petition was handed to the U.S. Food and Drug Administration (FDA) by Dr. Charles Bennett of the University of South Carolina. He is requesting a new black box warning for all fluoroquinolones, saying all consumers and patients need to be made aware of all of the potential risks from the drugs, nerve and psychiatric. The black box warning is the strongest label the FDA can mandate.

This is not the only request filed by Dr. Bennett pertaining to this class of drugs. This request addresses the potential mental quinolone side effects, like hallucinations, amnesia, and suicidal thoughts that Cipro, Floxin and other fluoroquinolones can cause.

The risk being that these quinolone side effects can start at any time — during treatment to days, weeks or months after completion.

Another petition filed earlier in the year in collaboration with the Southern Network on Adverse Reactions (SONAR) requested a black box warning for mitochondrial toxicity.

Mitochondrial toxicity is one possible cause of peripheral neuropathy. Other causes can include alcoholism, autoimmune diseases, and diabetes. Peripheral neuropathy is when the nerves that send information to and from the brain and spinal cord to the rest of the body get damaged.

The impaired connection causes symptoms such as tingling, burning, numbness, or shooting pain in the arms and legs. Depending on what nerves are impacted, peripheral neuropathy symptoms can also vary.

Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation, supports the petition. In an article her organization released to the press she said, “most people would not look under ‘Central Nervous System Effects’ to find information about suicide, hallucinations, paranoia, or panic attacks. A specific heading for ‘Psychiatric Adverse Events’ is badly needed.”

She added that while the current label lists a number of adverse psychiatric possibilities, “they are essentially hidden under the heading, ‘Central Nervous System Effects.’”

Dangers of Peripheral Neuropathy

One of the more dangerous risks from fluoroquinolone antibiotics is potentially permanent nerve damage, known as peripheral neuropathy.

Listed on the fluorquinolone label since 2004, peripheral nerve damage can be “long-lasting” and potentially cause permanent nerve damage in fluoroquinolone users.

Recent findings as to the side effects are such that the FDA mandated updates to the warning labels on fluoroquinolone antibiotics in 2013 “to better describe the serious side effect of peripheral neuropathy.”

The updated label informs consumers to seek medical treatment if they experience any of the mentioned symptoms, and suggest a change to antibiotic regimens if peripheral neuropathy seems possible.

Science has backed up FDA concerns. University of British Columbia researchers found that first-time users of oral fluoroquinolones risks of suffering peripheral neuropathy can be almost two times that of those who don’t take the antibiotics.

It should be noted that fluoroquinolones are meant to, and should be reserved to, treat bacterial infections.

According to the FDA, “approximately 23.1 million unique patients received a dispensed prescription for an oral fluoroquinolone product from outpatient retail pharmacies during 2011.”