Physicians continue to overprescribe fluoroquinolones

FDA has received reports of hundreds of thousands of serious adverse events associated with fluoroquinolones from more than 60,000 patients since the 1980s. The most frequent adverse effects include tendon rupture and neurological and psychiatric symptoms. However, experts estimate that only a small fraction of such events are reported to FDA.

Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy in Columbia, SC, believes fluoroquinolones may have injured hundreds of thousands of people nationwide, Despite FDA warnings and several patient reports about adverse effects, many health care providers continue to improperly prescribe fluoroquinolones for conditions such as simple urinary tract infections, sinus infections, and respiratory issues.

FDA-approved fluroquinolones include ciprofloxacin, ciprofloxacin extended-release tablets, delafloxacin, gemifloxacin, levofloxacin, moxifloxacin, and ofloxacin. FDA regulators have not prohibited the use of fluoroquinolones for use in the treatment of bacterial infections in light of their benefit for certain conditions.

However, the agency has required an escalating series of warnings and safety labeling changes, with the first black box warning added in 2008. Former FDA Commissioner Scott Gottlieb, MD, noted that “For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections, but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”