Fluoroquinolones and Peripheral Neuropathy

Fluoroquinolones are a class of antibiotics that include ciprofloxacin (brand names: Cipro, Cetraxal and Proquin), levofloxacin (Levaquin, Quixin and Iquix), moxifloxacin (brand name: Avelox), gemifloxacin (brand name: Factive) and ofloxacin (brand name: Ofloxacin). One potential side effect that may occur after using Levaquin or another fluoroquinolone is peripheral neuropathy, which is damage to the peripheral nerves such as those affecting the hands and feet.

In 2013, the U.S. Food and Drug Administration (FDA) required a label update on fluoroquinolones to better reflect the risk of peripheral neuropathy. According to the safety announcement, the peripheral neuropathy may occur soon after taking these antibiotics and may be permanent. The FDA advised patients to contact their health care professionals right away if they develop symptoms of peripheral neuropathy, which include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position. These symptoms may appear any time during treatment and last for months to years after treatment is stopped. In some cases, the nerve damage may be permanent, the FDA said.

In 2014, the journal Neurology published a study evaluating the risk of peripheral neuropathy associated with fluoroquinolone use. Researchers followed men between the ages of 45 and 80 from 2001 to 2011. They compared 6,226 cases of men with peripheral neuropathy to 24,904 matched controls. The authors concluded that use of fluoroquinolones was associated with a higher risk of peripheral neuropathy, especially in new users. “Despite the increase in the use of FQs, clinicians should weigh the benefits against the risk of adverse events when prescribing these drugs to their patients.” the researchers advised.

The FDA released a safety announcement regarding fluoroquinolones in May, warning that the risks generally outweighed the benefits in patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections. The agency said fluoroquinolones should only be used to treat these conditions if no other options are available due to the risk of “disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.”

In its QuarterWatch Annual report, the Institute for Safe Medication Practices (ISMP) recently found that fluoroquinolones were associated with the greatest number of persistent adverse event reports leading to long-term health problems. Levofloxacin (brand names: Levaquin, Quixin and Iquix) accounted for 489 reports (57.2%) and ciprofloxacin (brand names: Cipro, Cetraxal and Proquin) accounted for 366 reports (42.8%). The most common persistent adverse events reported were painful joint, muscle and tendon disorders. Among affected patients, 65 percent described the event as “disabling”. The report is based on complaints submitted to the FDA adverse event database.

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