title: Unintended Consequences of Adjusting Citalopram Prescriptions Following the 2011 FDA Warning.
abstract: OBJECTIVE
  In 2011, the U.S. Food and Drug Administration (FDA) issued a safety announcement cautioning providers against prescribing citalopram above 40 mg per day given concerns for QT prolongation. We assessed the impact of a health system quality improvement initiative to identify patients taking higher than the recommended dose of citalopram.
  
  
  METHODS
  Retrospective cohort study.
  
  
  METHODS
  Nine primary care clinics within the University of Michigan from March 2012 to February 2013.
  
  
  METHODS
  Adult patients taking a higher-than-recommended dose of citalopram following the FDA warning in 2011 (N = 199).
  
  
  METHODS
  Frequency of EKG monitoring, clinical factors associated with patients whose citalopram dose or use was adjusted, and potential impact of these changes on overall health care utilization was assessed.
  
  
  RESULTS
  In patients prescribed higher-than-recommended doses of citalopram and who received a note from a pharmacist regarding the FDA warnings, only 8.5% received electrocardiogram (EKG) monitoring. Patients who were converted to an alternative antidepressant from citalopram were more likely to receive subsequent new prescriptions for benzodiazepines and sedative hypnotics (χ2= 7.9, p = 0.048). Patients who had any adjustments to their antidepressant medication had greater overall health care utilization (OR: 25.0; 95% CI: 5.7-109.6; p < 0.001) than patients remaining on the same dose of citalopram.
  
  
  CONCLUSIONS
  Despite a targeted quality intervention to address the FDA warning regarding citalopram, the warning was associated with low levels of EKG monitoring, increased anxiolytic and sedative medication use, and higher healthcare utilization. This finding may represent destabilization of patients on previously therapeutic doses of their antidepressant and an unintended consequence of the FDA warning.
authors.affiliation: Department of Psychiatry, University of Michigan, Ann Arbor, MI. Electronic address: glauren@med.umich.edu.
authors.forename: Lauren B
authors.initials: LB
authors.lastname: Gerlach
authors.affiliation: Department of Psychiatry, University of Michigan, Ann Arbor, MI; Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI.
authors.forename: Helen C
authors.initials: HC
authors.lastname: Kales
authors.affiliation: Department of Psychiatry, University of Michigan, Ann Arbor, MI; Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI.
authors.forename: Donovan T
authors.initials: DT
authors.lastname: Maust
authors.affiliation: Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI.
authors.forename: Claire
authors.initials: C
authors.lastname: Chiang
authors.affiliation: Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI.
authors.forename: Claire
authors.initials: C
authors.lastname: Stano
authors.affiliation: College of Pharmacy, University of Michigan, Ann Arbor, MI.
authors.forename: Hae Mi
authors.initials: HM
authors.lastname: Choe
authors.affiliation: Department of Psychiatry, University of Michigan, Ann Arbor, MI; Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI.
authors.forename: Kara
authors.initials: K
authors.lastname: Zivin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015283:Citalopram / Q000008:administration & dosage* / Q000009:adverse effects; D004348:Drug Labeling / Q000706:statistics & numerical data*; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D004562:Electrocardiography / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced* / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors
keywords: Citalopram; EKG monitoring; FDA warning; QT prolongation