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Floxin (ofloxacin), a popular antibiotic medication, has been linked to a doubled risk of peripheral neuropathy (nerve damage). This rare disorder can cause muscle weakness, chronic pain, sensory changes, numbness, and other side effects that may be incurable.

What is Floxin?

Floxin (ofloxacin) is a prescription antibiotic medication in the fluoroquinolone class. It is manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc. It was approved by the U.S. Food and Drug Administration (FDA) in December 1990.

What Does Floxin Treat?

  • acute bacterial exacerbation of chronic bronchitis
  • community-acquired pneumonia
  • acute pelvic inflammatory disease (PID)
  • acute, uncomplicated cervical and urethral gonorrhea
  • urethritis or cervicitis due to Chlamydia or gonorrhea
  • uncomplicated cystitis
  • uncomplicated skin and skin structure infections
  • complicated urinary tract infections (UTI)
  • prostatitis due to E. coli

Floxin Black Box Warning

Floxin and other fluoroquinolone antibiotics carry a “Black Box” warning — the strongest warning the FDA can require on a medication — about the risk of tendon injuries in people of all ages, but especially adults older than 60. Other risk-factors include corticosteroid drugs and patients who have had a kidney, heart, or lung transplant. The Achilles tendon is most frequently injured, and it may require surgery.

Floxin Side Effects

The most common side effects of Floxin include sleep problems, headache, dizziness, nausea, vomiting, diarrhea, itching, external genital itching in women, vaginal inflammation (vaginitis), and taste changes.

Serious side effects of Floxin include:

  • Central nervous system effects (seizures, light-headedness, hallucinations, restlessness, tremors, anxiety, confusion, depression, trouble sleeping, nightmares, paranoia, suicidal thoughts or acts)
  • Allergic reactions
  • Skin rash
  • Intestinal infections
  • Nerve damage (peripheral neuropathy) and changes in sensation
  • Heart rhythm changes
  • Sensitivity to sunlight
  • Low blood sugar (hypoglycemia)
  • False-positive urine test for opiate drugs

Floxin and Nerve Damage (Peripheral Neuropathy)

Peripheral neuropathy is a rare but serious type of nerve damage. It is a side effect of all drugs in the fluoroquinolone class, including Factive.

Warnings about peripheral neuropathy were added to the label on Factive in 2004. It appears these warnings were not strong enough. In 2013, the FDA published updated warnings to emphasize that nerve damage can occur rapidly and cause permanent sensory changes.

Experts have been warning about these risks for over a decade. One study, published in 2001 in the Annals of Pharmacotherapy, found that over 80% of cases occurred within one week, and over 60% persisted for at least one year. In August 2014, Neurology published a study of 1 million men and found that those on fluoroquinolone antibiotics were twice as likely to develop peripheral neuropathy.

Floxin and Aortic Aneurysms

Aortic aneurysms can grow for years without causing any symptoms, which is why they are sometimes called “silent killers.” When symptoms do appear, it is usually because the wall of the aorta has ripped open (called a dissection) or the aorta has ruptured and caused severe internal bleeding.

Two studies have found that aortic aneurysms are more likely in people who use fluoroquinolone antibiotics. In October 2015, a study published by researchers in Taiwan found a 2.4-fold increased risk. In November 2015, a study involving 650,000 people found a 3.1-fold increased risk.