title: Strategies for the prescription of psychotropic drugs with black box warnings.
abstract: BACKGROUND
  The Black Box Warning (BBW) is the Food and Drug Administration's highest level of drug warning. It signifies that a medication has serious (or potentially life-threatening) side effects and is prominently displayed on a medication's package insert. It literally consists of the medication warning and is surrounded by a bold black border.
  
  
  OBJECTIVE
  This article aims to review data related to BBWs on psychotropic medications currently used in clinical practice, with special attention to clinical situations and questions relevant to consultation-liaison psychiatrists.
  
  
  RESULTS
  We review 3 clinical advisories or BBWs for psychotropic medications (i.e., antidepressant medication and suicidality in the pediatric population, stimulant medication and sudden death in the pediatric population, and antipsychotic medication and increased mortality in the elderly) and discuss the effect they have had on prescribing practices. We provide a table of current BBWs relevant to psychotropic medications.
  
  
  CONCLUSIONS
  BBWs can have unintended and far-reaching consequences, albeit with a limited ability to target specific populations and practice patterns. Although it is critical for clinicians to be aware of these serious potential side effects and to inform patients about these warnings, medications with boxed warnings remain Food and Drug Administration-approved and may have critically important therapeutic roles.
authors.affiliation: Henry Ford Health Systems, Dearborn, MI; Wayne State University, Detroit, MI. Electronic address: jsteven8@hfhs.org.
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Stevens
authors.affiliation: Michigan State University, East Lansing, MI.
authors.forename: Tiana
authors.initials: T
authors.lastname: Jarrahzadeh
authors.affiliation: Red Sox Foundation and Massachusetts General Hospital (MGH), Home Base Program, Boston, MA; Harvard Medical School (HMS), Boston, MA.
authors.forename: Rebecca Weintraub
authors.initials: RW
authors.lastname: Brendel
authors.affiliation: Harvard Medical School (HMS), Boston, MA; Avery D. Weisman Psychiatry Consultation Service at MGH, Boston, MA.
authors.forename: Theodore A
authors.initials: TA
authors.lastname: Stern
mesh_terms: D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D000697:Central Nervous System Stimulants / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D016757:Death, Sudden, Cardiac / Q000209:etiology*; D003704:Dementia / Q000188:drug therapy; D003865:Major Depressive Disorder / Q000188:drug therapy; D004348:Drug Labeling; D006801:Humans; D009026:Mortality; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use; D059020:Suicidal Ideation; D013405:Suicide
chemical_list: D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D000697:Central Nervous System Stimulants; D011619:Psychotropic Drugs