FDA Requires Updates to Fluoroquinolone Safety Labeling
July 11, 2018 – The U.S. FDA has issued a statement on new required updates to safety labeling for fluoroquinolone antibiotics. The new labeling will warn of the risks of mental health side effects and serious blood sugar disturbances. In addition, the FDA has stated that this labeling must be more consistent across various fluoroquinolone products.
Fluoroquinolone antibiotics are used to treat serious bacterial infections, and can be given by mouth or by injection. Affected products include: Levaquin® (levofloxacin), Cipro® (ciprofloxacin), Cipro® XR (ciprofloxacin extended-release tablets), Avelox® (moxifloxacin), Floxin® (ofloxacin), Factive® (gemifloxacin), and Baxdela™ (delafloxacin). According to the FDA, more than 60 generic forms of fluoroquinolone antibiotics are currently available on the U.S. market.
The new label updates result from a review of adverse event reports that were received by the FDA, as well as case reports published in medical literature. This review revealed a range of mental health side effects, as well as instances of hypoglycemic coma. Drugs in the fluoroquinolone class already carry information regarding mental health side effects in the Warnings and Precautions section of the drug labeling. However, the nature of this labeling varied from one product to another. The FDA will now require that the mental health side effects be listed consistently across all drugs in the class and be kept separate from listings of other central nervous side effects. The Blood Glucose Disturbances subsection of the labeling for all systemic fluoroquinolones must now explicitly state the risk of hypoglycemic coma.
Over the past decade, the FDA has made a number of changes to the required warnings on fluoroquinolone antibiotic labeling. Drugs in the class received a black box warning in 2008 regarding the risk of tendinitis and tendon ruptures, with an additional black box warning issued in 2011 for the worsening of myasthenia gravis, a chronic disorder that causes muscle weakness, in patients who have the disease. In 2013, the FDA required a label update to reflect the potential for irreversible peripheral neuropathy (serious nerve damage) associated with fluoroquinolone use. More recently, in 2016, the FDA required enhanced warnings be added in regards to the risk of disabling and potentially permanent side effects that involve tendons, muscles, joints, nerves, and the central nervous system.
Due to the serious nature of the possible side effects associated with fluoroquinolone, products in the class should not be used in patients who have acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, or uncomplicated urinary tract infections unless other options have been exhausted. Patients should be provided with a Medication Guide that details the risks associated with use of the drugs. Fluoroquinolones should only be prescribed when the benefits outweigh the risks.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.