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Fluoroquinolone-associated suicide

  • Author Footnotes
    1 Anuhya Kommalapati and Sara Wallam contributed equally.
    Anuhya Kommalapati
    Footnotes
    1 Anuhya Kommalapati and Sara Wallam contributed equally.
    Affiliations
    University of South Carolina School of Medicine, Columbia, SC 29203, USA
    Search for articles by this author
  • Author Footnotes
    1 Anuhya Kommalapati and Sara Wallam contributed equally.
    Sara Wallam
    Footnotes
    1 Anuhya Kommalapati and Sara Wallam contributed equally.
    Affiliations
    University of South Carolina, Columbia, SC 29203, USA
    Search for articles by this author
  • Sri Harsha Tella
    Affiliations
    University of South Carolina School of Medicine, Columbia, SC 29203, USA
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  • Zaina P. Qureshi
    Affiliations
    South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC 29203, USA

    Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA

    Arnold School of Public Health, University of South Carolina, Columbia, SC 29203, USA

    William Jennings Bryan Dorn VA Medical Center, Columbia, SC, USA
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  • Charles L. Bennett
    Correspondence
    Corresponding author at: SmartState Center for Medication Safety and Efficacy, University of South Carolina College of Pharmacy, 715 Sumter Street, Coker Life Science Room 311, Columbia, SC 29208, USA.
    Affiliations
    South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC 29203, USA

    Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA

    Arnold School of Public Health, University of South Carolina, Columbia, SC 29203, USA

    William Jennings Bryan Dorn VA Medical Center, Columbia, SC, USA
    Search for articles by this author
  • Author Footnotes
    1 Anuhya Kommalapati and Sara Wallam contributed equally.
      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 [
      • European Medicines Agency
      Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics.
      ]. 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 [
      • FDA Drug safety Communication
      FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together.
      ]. In February 2017, the levofloxacin manufacturer expanded the suicide-related events in the warnings section of the product label [

      Medication Guide for Levofloxacin (revised February 2017). Janssen pharmaceutical companies, Titusville, NewJersey. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf. (Accessed November 22, 2017).

      ]. 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.

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      References

        • European Medicines Agency
        Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics.
        (Dated: June 13, 2018)
        • FDA Drug safety Communication
        FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together.
      1. Medication Guide for Levofloxacin (revised February 2017). Janssen pharmaceutical companies, Titusville, NewJersey. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf. (Accessed November 22, 2017).

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