The FDA has required the drug labels for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy.This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.
The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include
- levofloxacin (Levaquin),
- ciprofloxacin (Cipro),
- moxifloxacin (Avelox),
- norfloxacin (Noroxin),
- ofloxacin (Floxin), and
- gemifloxacin (Factive).
The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.
If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.
Peripheral neuropathy is a nerve disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position. It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent.
Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should tell their health care professionals right away.
However, these are widely used and sometimes lifesaving drugs:
- Approximately 23.1 million unique patients received a dispensed prescription for an oral fluoroquinolone product from outpatient retail pharmacies during 2011. Patients receiving a dispensed prescription for ciprofloxacin, levofloxacin, or moxifloxacin accounted for 70%, 28%, and 9% of the total number of patients, respectively, during 2011. Gemifloxacin, ofloxacin, and norfloxacin each accounted for less than 1% of total patients during 2011.
- Within the hospital setting, there were approximately 3.8 million unique patients billed for an injectable fluoroquinolone product during 2011. Levofloxacin, ciprofloxacin, and moxifloxacin accounted for 63%, 28%, and 13% of total unique patients, respectively, during 2011; hospital billing for ofloxacin was not captured.
FDA has required manufacturers of systemic fluoroquinolone drugs to make revisions to the drug labels (Warnings/Precautions and Warnings and Precautions sections) and the Medication Guides. These label changes are to better characterize the risk of peripheral neuropathy associated with the class of systemic fluoroquinolones. If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be treated with an alternative non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk.
If you are taking a fluoroquinolone drug by mouth or by injection, know that it may cause symptoms in the arms or legs such as pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature . These symptoms can occur early in treatment and may be permanent.
There have been previous warnings about these drugs. In 2012, studies showed “…link to tendinitis and tendon rupture… ability to block neuromuscular activity”.
Fluoroquinolones Antibiotic Alert – especially with EDS