This article is more than 5 years old. Information may no longer be current.
Fluoroquinolones pose risk for aortic, mitral regurgitation
Click Here to Manage Email Alerts
Current and recent use of fluoroquinolones, but not past use, were associated with elevated risk for aortic and mitral regurgitation, researchers reported.
“[Fluoroquinolones are] very convenient, but for the majority of cases, especially community-related infections, they’re not really needed,” Mahyar Etminan, PharmD, MSc, associate professor of ophthalmology and visual sciences in the faculty of medicine at the University of British Columbia in Vancouver, Canada, said in a press release. “The inappropriate prescribing may cause both antibiotic resistance as well as serious heart problems.”
Etminan and colleagues conducted a disproportionality analysis from cases of drug-related adverse events from the FDA Adverse Event Reporting System database. They also conducted an analysis of 12,505 cases and 125,020 controls from a random sample of more than 9 million people from the U.S. PharMetrics Plus database, for which users of fluoroquinolones were compared with users of amoxicillin and azithromycin.
Current use of fluoroquinolones was defined as an active prescription at the index date or up to 30 days before the event date. Recent use of fluoroquinolones was defined as use within 31 to 60 days of the event date. Past use was defined as use at 61 to 365 days before the event date.
Regurgitation risk
For the disproportionality analysis, the OR was 1.45 (95% CI, 1.2-1.77), according to the researchers.
Compared with amoxicillin and azithromycin users, current users of fluoroquinolones had elevated risk for aortic and mitral regurgitation (adjusted RR = 2.4; 95% CI, 1.82-3.16) as did recent users (aRR = 1.47; 95% CI, 1.03-2.09), but not past users (aRR = 1.06; 95% CI, 0.91-1.21), Etminan and colleagues wrote.
“It might be prudent to consider antibiotics that are chemically distinct to [fluoroquinolones] in patients with a previous history of valvular regurgitation who require antibacterial therapy,” Etminan and colleagues wrote. “Future studies are urgently required to confirm or refute these findings.”
Systematic problems
“What does it say about our system when a class of drugs — one that has been on the market for over 20 years — continues to have new, concerning information emerge in the face of 32.5 million outpatient prescriptions in the United States in 2015 alone?” Robert M. Califf, MD, MACC, Donald F. Fortin Professor of Cardiology at Duke University School of Medicine, member of the Duke Clinical Research Institute and former commissioner of the FDA, wrote in a related editorial. “Why has so little work been done on the underlying biology of fluoroquinolones and their putative effects on connective tissue?”
In the short term, he wrote “The FDA should use Sentinel [Network] to examine the relationship between fluoroquinolones and valvulopathy in detail. Until such work is finished, there should be a substantial reduction in use of fluoroquinolones, which should be prescribed only as a last resort. In the longer run, the FDA and the larger clinical ecosystem should accelerate the creation of superior information infrastructure.” – by Erik Swain
Disclosures: The authors report no relevant financial disclosures. Califf reports he sits on the corporate board for Cytokinetics and is board chair for the People-Centered Research Foundation; he has received consultant fees from Amgen, Biogen, Boehringer Ingelheim, Genentech, Eli Lilly and Merck; and has been employed as an adviser for Verily Life Sciences (Alphabet).
Click Here to Manage Email Alerts