The U.S. Food & Drug Administration (FDA) has warned that the antibiotic drug Floxin (generic: ofloxacin) may cause severe nerve damage and tendon injuries in some patients. If you were injured by Floxin, and you’re interested in filing a class action lawsuit against the manufacturers, our lawyers can help.
Update: Fluoroquinolone Antibiotics May Cause Fatal Heart Damage, FDA Warns
December 21, 2018 – Fluoroquinolones could increase the risk of an aortic dissection, and people who are already at risk should be cautious about taking these medications, the U.S. Food & Drug Administration (FDA) warned in a Drug Safety Communication issued on Thursday.
“A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta,” the agency said. “These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.”
What is Floxin?
Floxin was a fluoroquinolone antibiotic medication used to treat bronchitis, pneumonia, skin infections, urinary tract infections (UTIs), certain sexually transmitted diseases (STDs) and prostatitis. Floxin was initially patented as ofloxacin in 1982, and approved by the FDA in 1990. Johnson & Johnson (J&J) marketed Floxin until 2009, and until it discontinued the product, it was sold as oral tablets, injectable solutions and topical formulations.
Floxin and Peripheral Neuropathy
In 2001, a study published in the Annals of Pharmacotherapy uncovered a link between Floxin and long-term side effects that involve nerves (peripheral neuropathy) and other organ systems. The study’s authors determined that the onset of these injuries was typically rapid — 33% of events appeared within 24 hours of first use, 68% of cases began within 72 hours, and 84% occurred within one week of beginning treatment. Symptoms persisted for at least three months in 71% of patients, and over one year in 58% of patients.
In August of 2013, the FDA published a Drug Safety Communication regarding the peripheral neuropathy risk associated with fluoroquinolone antibiotics like Floxin. FDA stated that neuropathy can occur in one week or less after first taking the drugs, and that some complications may be irreversible. According to the FDA:
“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.”
Floxin Side Effects
- Peripheral Neuropathy
- Tendon rupture / damage
- Stevens-Johnson syndrome (SJS)
- Toxic Epidermal Necrosis (TEN)
- Central nervous system disorders
- Hypersensitivity reactions
- Loss of consciousness
- Cardiovascular collapse
- Life-threatening skin reactions