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Factive Peripheral Neuropathy Lawsuit


In 2004, the label on the antibiotic medication Factive (gemifloxacin) was updated to include the risk of peripheral neuropathy (nerve damage).

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 Factive (gemifloxacin)?

Factive (gemifloxacin) is a fluoroquinolone antibiotic that is prescribed to treat adults with lung infections, including chronic bronchitis and pneumonia. It is usually taken once a day, by mouth, with or without food, for 5-7 days, though treatment may vary depending on a doctor’s instructions.

Study of Factive and Peripheral Neuropathy

One of the first studies of peripheral neuropathy and fluoroquinolone antibiotics was published in the Annals of Pharmacotherapy in 2001. Although previous reports suggested that nerve damage was mild and short-lived, the study found evidence of severe, long-term side effects involving multiple organ systems.

The researchers found that onset of peripheral neuropathy was rapid — 84% of cases occurred within one week, 68% of cases occurred in 72 hours, and 33% occurred in 24 hours. More than 70% of patients had symptoms that persisted for at least three months, and 58% still had symptoms after one year.

FDA Warning for Factive and Peripheral Neuropathy

The U.S. Food and Drug Administration (FDA) has published multiple warnings about the rapid onset of peripheral neuropathy and the risk of permanent nerve damage. The first warning was published in October 2004, and it was updated in August 2013. According to the FDA Warning for Factive 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 (nerve damage) is a disease of the peripheral nervous system. Their main function is to carry signals from the brain and spinal cord to organs and limbs. Factive is associated with sensory and motor neuropathy.

Symptoms of Peripheral Neuropathy

  • Tingling sensation in the toes or feet that spreads and worsens
  • Pain that is shooting or stabbing
  • Extreme touch sensitivity
  • Abnormal sense of touch, temperature, texture, pain, etc.
  • Numbness (feeling is described like wearing a thin sock)
  • Muscle weakness and atrophy
  • Decreased sense of body position
  • Problems walking and balancing
  • Decreased muscle coordination
  • Loss of reflexes
  • Loss of fine motor skills
  • And more


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