Fluoroquinolone-associated suicide

Suicide is a huge global health problem and is the tenth leading cause of death in the United States. Several case reports have raised concerns that exposure to fluoroquinolones (FQs) may increase the risk of suicidal behavior. Though FQs, including levofloxacin, ciprofloxacin, and moxifloxacin have been available for the last 3 decades, there has been a significant paradigm shift about their safety in the last five years (Supplementary Table 1). Recently, European Medicines Agency has started undertaking a detailed investigation on long-term side effects primarily affecting neurological and musculoskeletal system [ ]. In 2013, FQ labeling for levofloxacin, ciprofloxacin, and moxifloxacin, respectively had been revised to indicate that suicide represented “isolated” reports, events that were “reported in <1% of treated patients,” and “very rarely reported adverse events”. In 2015, a new syndrome termed “FQ associated disability” was described that included serious and disabling side effects that followed even one or two FQ doses. Given their serious and disabling side effects that can occur even with one to two doses, the Food and Drug Administration (FDA) issued a public health announcement that use of FQs should be reserved for patients who have no other alternate options [ ]. In February 2017, the levofloxacin manufacturer expanded the suicide-related events in the warnings section of the product label [ ]. Similar revisions were not disseminated for ciprofloxacin and moxifloxacin. In this study, we reviewed FDA reports of suicidal behaviors associated with all FDA-approved FQs and evaluated reporting completeness, as many FDA-reported adverse events lack key clinical information.