FDA Issues Antibacterial Drug Recommendation
May 12, 2016 – In a Drug Safety Communication, the U.S. Food and Drug Administration (FDA) recommended limiting the use of antibacterial drugs in the fluoroquinolone (quinolone) class. The FDA has determined that the risks of using quinolones for patients with uncomplicated bronchial, sinus and urinary tract infections are not justified when alternative therapies are available. Among their very serious possible side effects are anaphylaxis (a severe allergic reaction), intestinal infections, nerve damage, ruptured tendons, seizures and vision loss. Although reports of serious side effects are uncommon, the problems can cause permanent impairment or even death. The affected drugs are ciprofloxacin (Cipro®, generics), gemifloxacin (Factive®, generics), levofloxacin (Levaquin®, generics), moxifloxacin (Avelox®, generics), and ofloxacin. Labeling for all injected and oral quinolones now will include information on their possible risks. Ophthalmic (eye drop) and otic (ear drop) quinolones do not have the same chance of adverse effects, so they will not have a warning. When possible, a different drug should be prescribed to treat uncomplicated bacterial infections, especially for any patient who may have had previous problems with a 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 a 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.