RESUMEN
OBJECTIVES: The Division of Drug Information (DDI) within the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research receives telephone calls, e-mails, and letters from patients and industry. The consistently high number of contacts about drugs in the fluoroquinolone class indicates an opportunity to increase awareness about the drugs' evolving safety profile. DATA SOURCES: Database used by DDI to summarize inquiries. SUMMARY: Inquiries about fluoroquinolones peaked in 2016 and were highest after FDA Drug Safety Communications that were issued that year. Among the first fluoroquinolone, ciprofloxacin, was approved in 1987. Since then, the FDA has required class-wide labeling changes reflecting postmarket benefit-risk assessments of oral and injectable (systemic) fluoroquinolones, including changes in 1990, 2008, 2013, 2016, and 2018. CONCLUSION: Pharmacists have a role that is more critical than ever to ensure the safety of patients who are prescribed a systemic fluoroquinolone. Pharmacists should stay informed on this class of drugs, be prepared to suggest alternate therapies, counsel patients on potential benefits and risks, and work with patients to submit Medwatch reports to the FDA if adverse events occur.
