Oral and intravenous (IV) forms of the antibiotic Floxin (ofloxacin) have been linked to peripheral neuropathy. This rare side effect can cause severe nerve pain, muscle weakness, and decreased sensation. In 2013, the FDA revised the Medication Guide with stronger warnings about Floxin and peripheral neuropathy. The new warnings emphasize that nerve damage can occur rapidly and it may be permanent.
UPDATE: Nerve Damage Risk Doubles for Users of Some Antibiotics
August 25, 2014 — A study published in Neurology has found a doubled increased risk of peripheral neuropathy (nerve damage) from the use of antibiotics in the fluoroquinolone (FQ) class. Click here to read more.
What is Floxin (ofloxacin)?
Floxin (ofloxacin) is an antibiotic that belongs to the fluoroquinolone class. It works by preventing bacteria from reproducing and repairing their DNA. It was created by Ortho-McNeil Pharmaceuticals and approved in 1990. It was discontinued in the U.S. in June 2009, although generic Floxin remains available.
Types of ofloxacin and uses include:
- Oral Floxin (ofloaxacin): Treats bacterial infections of the skin, bladder, urinary tract, respiratory tract (pneumonia, bronchitis), sexually transmitted diseases (gonorrhea, chlamydia), and more.
- Ofloxacin otic: Ear drops that are used to treat outer-ear and chronic middle-ear infections (also known as “swimmer’s ear”) in adults and children with a perforated eardrum.
- Ophthalmic ofloxacin: Eye drops that treat conjunctivitis (pink eye).
Study of Floxin and Peripheral Neuropathy
In 2001, in the Annals of Pharmacotherapy published a study linking Floxin to peripheral neuropathy and severe, long-term side effects that involve nerves and other organ systems.
Researchers found that the onset of adverse events was usually rapid — 33% of events began within 24 hours, 68% of cases began within 72 hours, and 84% of cases occurred within one week. Symptoms lasted for at least three months in 71% of patients, and more than one year in 58% of patients.
FDA Warning for Floxin and Peripheral Neuropathy
The FDA added warnings about the risk of peripheral neuropathy to the label on Floxin in October 2004. In August 2013, they updated these warnings to emphasize the rapid onset and potentially permanent complications. According to the Safety Warning for Floxin and Peripheral Neuropathy:
“The onset of peripheral neuropathy after starting fluoroquinolone therapy was rapid, often within a few days. In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone. Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms.”
What is Peripheral Neuropathy (Nerve Damage)?
Peripheral neuropathy is an injury to peripheral nerves, which carry signals from the brain to the spinal cord and body, all the way to the toes and fingertips. Floxin is associated with neuropathy of sensory and motor nerves, which can cause paresthesia (burning, tickling, or prickling sensations) and problems with motor coordination.
Symptoms of Peripheral Neuropathy
- Abnormal sense of touch, texture, temperature, or pain
- Chronic nerve pain that is shooting or stabbing
- Extreme sensitivity to touch
- Numbness (may feel as if the patient is wearing a thin stocking)
- Decreased sense of balance or body position
- Problems walking
- Loss of fine motor skills
- Muscle weakness
- And more