August 22, 2013
FDA is requiring manufacturers of systemic fluoroquinolones (levofloxacin, moxifloxicin, ciprofloxacin, norfloxacin , ofloxacin , and gemfloxicin) to revise the drug labels and Medication Guides for these agents to better characterize the associated risk of peripheral neuropathy. While this class side effect has been included in fluoroquinolone product labels since 2004, new information suggests it is not adequately described. Oral and injectable fluoroquinolone use continues to result in reports of peripheral neuropathy that can occur within days of starting treatment and can last weeks to years or, in some cases, become permanent after discontinuing therapy. Patients receiving topical formulations (eg, ophthalmic, otic) do not appear to be at risk. Symptoms of peripheral neuropathy include burning, tingling, numbness, weakness, pain or a change in perception to touch, pain or temperature occurring in the arms or legs. This information comes from FDA’s Adverse Event Reporting System (AERS), which evaluated case reports from January 2003 to August 2012. Due to the spontaneous nature of the reporting system, no incidence information is available. To date, FDA has not found any patient-specific risk factors leading to the adverse event.
Advise patients who develop peripheral neuropathy to stop the medication immediately, inform their healthcare provider, and switch to a nonfluoroquinolone antibacterial medication if appropriate. In some cases continued use of fluoroquinolones is warranted if the benefit outweighs the risk. Advise patients of the risks and benefits of fluoroquinolone use before beginning treatment and if continued treatment despite side effects may be warranted. Report any adverse reaction to fluoroquinolones to the FDA MedWatch program.
FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant
public health concern. Distribution requirements and exceptions (eg, certain inpatient care situations) for Medication Guides are addressed in an FDA Guidance Document: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. Medication Guide distribution requirements are stricter for medications with a Risk Evaluation and Mitigation Strategy (REMS) that includes Elements To Assure Safe Use (ETASU) with specific requirements for providing and reviewing the Medication Guide:
A complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.
More information is available at the following links:
- FDA MedWatch Alert:
- FDA Safety Information:
08/22/2013 University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.