Fluoroquinolones Restrictions from FDA
FDA Recommends Restricting the Use of Fluoroquinolones Due to Potential Side Effects
The FDA has recently released a statement indicating that the use of systemic fluoroquinolones should be restricted due to the potential for serious “disabling and potentially permanent” side effects involving tendons, muscles, joints, nerves and the central nervous system.
Examples of Fluoroquinolone antibiotics include Avelox (moxifloxacin), Cipro (ciprofloxacin), Factive (gemifloxacin), Levaquin (levofloxacin) and Floxin (ofloxacin).
The FDA advised that the risk of serious side effects frequently outweighs the benefit in patients receiving fluoroquinolones for the treatment of sinusitis, bronchitis and uncomplicated urinary tract infections for which other treatment options are available. The use of fluoroquinolones should be reserved only for cases where other treatment options do not exist.
Potential side effects include tendon, joint and muscle pain, tendonitis, tendon rupture, peripheral neuropathy, confusion and hallucinations, exacerbation of Myasthenia Gravis, QT prolongation, phototoxicity and hypersensitivity. These side effects can occur together. If a patient experiences any of these side effects, treatment with the fluoroquinolone should be discontinued and the course of treatment should be completed with a non-fluoroquinolone antibiotic.
Any side effects should be reported to the FDA’s MedWatch program at https://www.accessdata.fda.gov/scripts/medwatch/medcatch-online.htm
References: 1. FDA Drug Safety Communication “FDA Advises Restricting Fluoroquinolone Antibiotic use for Certain Uncomplicated Infection; Warns about Disabling Side Effects that Can Occur Together” http://www.fda.gov/downloads/Drugs/DrugSafety/UCM500591.pdf, accessed May 13, 2016. 2. Lowes, Robert “Limit Fluoroquinolone Use in Light of Risk, FDA Says” Medscape Medical News. http://www.medscape.com/viewarticle/863256 – Accessed May 13, 2016.
This article was originally published in our monthly issue of From the Front Lines – a monthly publication that shares best practices and medication-related challenges faced by “front line” staff in long-term care and post-acute (LTCPAC) facilities.