FDA: Use Fluoroquinolone to Treat Infections With Caution

By on 8:31 AM

The U.S. Food and Drug Administration has strengthened its black box warning regarding fluoroquinolone use to help better protect patients.

The updated warning notes the association between fluoroquinolones and disabling and potentially permanent side effects, such as decreases in blood sugar (which can lead to coma) and some mental health issues. FDA is advising healthcare providers to limit fluoroquinolone use in patients with less serious bacterial infections.

A recent Clinical Infectious Diseases study shows that fluoroquinolones are commonly prescribed for conditions when antibiotics are not needed or when fluoroquinolones are not the recommended first-line therapy.

Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections. Used for more than 30 years, they work kill or stop the growth of bacteria that can cause illness.

FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive) and delafloxacin (Baxdela). There are more than 60 generic versions. The safety labeling changes were based on a comprehensive review of the FDA's adverse event reports and case reports published in medical literature, according to an FDA news release.

"The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option," said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in the release. "The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that healthcare providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use."

Improving antibiotic prescribing and antibiotic stewardship, an area of focus for infection prevention consulting firm ICCS, is important to prevent serious adverse events and potentially deadly infections.

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.