The FDA has recently warned that Floxin (ofloxacin), an antibiotic medication, increases a patient’s risk of developing peripheral neuropathy. This debilitating type of nerve damage can occur rapidly and cause permanent muscle weakness, numbness, chronic pain, sensory changes, and more.
What is Floxin?
Floxin (ofloxacin) belongs to a class of antibiotics called fluoroquinolones. It has been approved in the United States since December 1990 and it is manufactured by Ortho-McNeil-Janssen Pharmaceuticals Inc.
What Does Floxin Treat?
Floxin is a broad-spectrum antibiotic that is approved to treat adults with bacterial infections, including sexually transmitted infections. It is also used to treat some types of ear infections and eye infections (conjunctivitis or “pink eye”). It is sometimes used “off-label” to treat travelers’ diarrhea and other infections.
Floxin may be used to 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
Like all fluoroquinolone antibiotics, Floxin carries a Boxed Warning about the risk of tendon injuries, including tendinitis (tendon inflammation) and tendon ruptures. These injuries affect the fibrous connective tissues between bones and muscles.
Pain, swelling, inflammation, and tears of tendons including the Achilles, shoulder, hand, or other tendons can happen in patients taking fluoroquinolone antibiotics. The Achilles tendon is at the back of the ankle. The chance of getting tendon problems is higher if you are:
- over 60 years of age
- taking steroids (corticosteroids)
- a kidney, heart, or lung transplant recipient
Floxin Side Effects
Common side effects include problems sleeping, headache, dizziness, nausea, vomiting, diarrhea, vaginitis (inflammation of the vagina), external genital itching in women, and changes in taste.
More serious side effects of Floxin may include:
- Suicidal thoughts or acts
- Allergic reactions
- Intestinal infections
- Nerve damage (peripheral neuropathy) and changes in sensation
- Heart rhythm changes
- Low blood sugar (hypoglycemia)
- And more
Floxin and Nerve Damage
The Prescribing Information for Floxin has carried warnings about peripheral neuropathy (nerve damage) since 2004. In 2013, the FDA published an updated Drug Safety Communication to warn that nerve damage can occur rapidly (within days) and cause permanent side effects.
In fact, researchers have known about the risk of nerve damage for over a decade. In 2001, the Annals of Pharmacotherapy published a study of fluoroquinolone antibiotics, in which peripheral neuropathy occurred within a week in over 80% of cases, and 60% persisted for at least one year. More recently, the journal Neurology published a study that found a doubled risk of peripheral neuropathy among people on fluoroquinolone antibiotics.
Floxin and Aortic Aneurysms
Floxin and other fluoroquinolone antibiotics were linked to higher rates of aortic aneurysms in two recent studies. Researchers warn that fluoroquinolones can damage collagen and connective tissue, which could explain why increased risks were observed.
One study, published in JAMA Internal Medicine in October 2015, analyzed data on 150,000 people in Taiwan who used fluoroquinolones. Past users of fluoroquinolones were 50% more likely to develop an aortic aneurysm, and people who used the medications within 60 days were 2.4-times more likely.
In November 2015, the British Medical Journal published a study involving 650,000 people who used fluoroquinolone antibiotics and found a 3.1-fold increased risk of aortic aneurysms.