Updated Safety Warnings for Fluoroquinolone Antibiotics

July 26, 2016 – The FDA has revisited its previous safety warnings for systemic (oral and injected) fluoroquinolone (quinolone) antibiotics and is requiring revision to Black Box warnings. The strengthening of the warning is a result of some patients taking or injecting a quinolone experiencing anaphylaxis (a severe allergic reaction), intestinal infections, nerve damage, ruptured tendons, seizures, vision loss and other rare, but serious, adverse effects. Oral and injected quinolones can cause problems that are often irreversible. Generally these antibiotics should only be used for severe infections, such as anthrax and plague. 

The risks associated with using quinolones are too great for them to be used routinely for uncomplicated acute bronchial, sinus and urinary tract infections. An oral or injected quinolone should only be used for uncomplicated infections when all other treatment options have failed. The FDA is requiring revisions to boxed warnings, other label sections and patient Medication Guides for ciprofloxacin (Cipro®, generics) extended-release oral tablets, oral suspension, oral tablets and solution for injection; levofloxacin (Levaquin®, generics) oral solution, oral tablets and solution for injection; gemifloxacin (Factive®, generics) oral tablets; moxifloxacin (Avelox®, generics) oral tablets and solution for injection; and ofloxacin oral tablets. Patients, caregivers and healthcare providers should be alert for symptoms, such as arrhythmias, light sensitivity, numbness, rashes and weakness in the arms or legs, among patients using a systemic quinolone.

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 regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular 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.