Peripheral neuropathy, a rare but serious type of nerve damage, has been linked to Floxin (ofloxacin) and other antibiotics in the fluoroquinolone class for more than a decade. However, our lawyers are concerned that the warnings about Floxin and peripheral neuropathy were inadequate. In August 2013, the U.S. Food and Drug Administration (FDA) published new warnings about the rapid onset of nerve damage, which may be permanent.
What is Floxin?
Floxin (ofloxacin) is an antibiotic medication in the fluoroquinolone class that is used to treat bacterial infections of the respiratory tract (bronchitis, pneumonia), skin, bladder, urinary tract, reproductive organs, and prostate. Ofloxacin otic is used to treat outer-ear and chronic middle-ear infections in adults and children with a perforated eardrum. Ophthalmic ofloxacin is also used to treat bacterial eye infections, such as pink eye (conjunctivitis).
Brand-name Floxin was approved in the U.S. in 1990 and discontinued in June 2009, but it is available as a generic. In 2011, fewer than 1% of oral antibiotic prescriptions were for Floxin.
Medication Guide on Floxin Updated to Include Peripheral Neuropathy
The label on Floxin includes this warning about the potential risk of peripheral neuropathy:
“Ofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition.”
FDA Warning for Floxin and Peripheral Neuropathy
The FDA published a Safety Announcement about all fluoroquinolone antibiotic drugs, including Floxin, that are taken by mouth or injection. The FDA warned that peripheral neuropathy can occur soon after these drugs are taken, and the complications may be permanently debilitating.
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.”
What Should I Do?
Discuss side effects of Floxin with your doctor. You should be familiar with the early symptoms of nerve damage (numbness, tingling, burning, weakness, etc.) and what you should do if these symptoms occur.
If you suspect Floxin is causing nerve damage, seek emergency medical attention. Do not stop taking Floxin without first talking to a doctor. You may need to switch antibiotics.
Contact a lawyer to discuss your drug injury. Although the link between Floxin and nerve damage has been known for over a decade, our lawyers are concerned that a lack of warnings about this side effect may have contributed to your injury.
What is Peripheral Neuropathy?
Peripheral neuropathy is a type of nerve damage that occurs when peripheral nerves fail to carry signals between the brain, spinal cord, and body. Damage to these nerves can cause several conditions, including paresthesia (burning, prickling, tingling), numbness, pain, and weakness.
Floxin is associated with sensorimotor polyneuropathy, which causes a decreased ability to move and feel due to nerve damage. In severe cases, this can cause difficulty using limbs, walking, balancing, and fine motor coordination.
Symptoms of Peripheral Neuropathy
- Nerve pain, burning, tingling, or numbness (paresthesia)
- Muscle weakness
- Abnormal sensation
- Decreased sense of touch, pain, or temperature
- Decreased sense of balance or body position
- Loss of reflexes
- Muscle weakness
- Loss of fine motor coordination
- Decreased mobility
- And more