Strategies for the prescription of psychotropic drugs with black box warnings

Psychosomatics
Jonathan R StevensTheodore A Stern

Abstract

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. 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. 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. 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 ...Continue Reading

References

Apr 8, 1995·BMJ : British Medical Journal·P HazellD Henry
Dec 28, 1999·JAMA : the Journal of the American Medical Association·P Lurie, L D Sasich
Jul 20, 2001·Journal of Psychiatric Research·I D GlickR J Hu
May 1, 2002·JAMA : the Journal of the American Medical Association·Karen E LasserDavid H Bor
Nov 20, 2002·Archives of Internal Medicine·Jeffrey M RothschildDavid W Bates
Feb 26, 2003·Psychotherapy and Psychosomatics·David Healy
Jun 5, 2003·The American Journal of Psychiatry·Mark OlfsonPeter S Jensen
Oct 16, 2004·The New England Journal of Medicine·David A Brent
Feb 9, 2005·Archives of General Psychiatry·Robert D GibbonsJ John Mann
Sep 22, 2005·Journal of the American Academy of Child and Adolescent Psychiatry·E Jane CostelloAdrian Angold
Oct 20, 2005·JAMA : the Journal of the American Medical Association·Lon S SchneiderPhilip Insel
Nov 19, 2005·Pharmacoepidemiology and Drug Safety·Anita K WagnerRichard Platt
Jan 3, 2006·The Journal of Allergy and Clinical Immunology·Shirley Murphy, Rosemary Roberts
Feb 16, 2006·Archives of Internal Medicine·Karen E LasserDavid W Bates
Sep 5, 2006·Pediatrics·Timothy E WilensJoseph Biederman
Dec 21, 2006·Journal of Child Psychology and Psychiatry, and Allied Disciplines·E Jane CostelloAdrian Angold
Jun 2, 2007·The American Journal of Psychiatry·Anne M LibbyRobert J Valuck
Jun 6, 2007·Annals of Internal Medicine·Sudeep S GillPaula A Rochon
Jul 4, 2007·Archives of Pediatrics & Adolescent Medicine·Benji T KurianWilliam O Cooper
Sep 5, 2007·Archives of Pediatrics & Adolescent Medicine·Tanya E FroehlichRobert S Kahn
Nov 8, 2007·The American Journal of Psychiatry·Elaine H MorratoRobert J Valuck
Dec 1, 2007·Journal of the American Academy of Child and Adolescent Psychiatry·Boris BirmaherJennifer Medicus
Feb 26, 2008·Journal of Child and Adolescent Psychopharmacology·Supriya K BhatiaChristopher J Kratochvil
Oct 4, 2008·Psychiatric Services : a Journal of the American Psychiatric Association·Colin DeppTodd P Gilmer
Mar 24, 2009·Current Neuropharmacology·Rosa LiperotiAndrea Corsonello
Jun 3, 2009·Archives of General Psychiatry·Anne M LibbyRobert J Valuck
Jan 6, 2010·Pharmacoepidemiology and Drug Safety·Carol A PamerAndrew D Mosholder
Jan 13, 2010·Archives of Internal Medicine·E Ray DorseyG Caleb Alexander
Apr 15, 2010·Journal of Clinical Child and Adolescent Psychology : the Official Journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53·Kate B Wolitzky-TaylorDean G Kilpatrick
Aug 3, 2010·Medical Care Research and Review : MCRR·Susan H BuschColleen L Barry
Apr 1, 2011·Journal of the American Medical Directors Association·Paula LesterMartin Feuerman
Oct 4, 2011·Journal of the American Academy of Child and Adolescent Psychiatry·Paul G HammernessTimothy E Wilens
Nov 3, 2011·The New England Journal of Medicine·William O CooperWayne A Ray
Feb 7, 2012·Lancet·Anita ThaparAjay K Thapar
Jan 16, 2013·Psychiatric Services : a Journal of the American Psychiatric Association·Rachel KornfieldG Caleb Alexander

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Citations

Sep 29, 2017·Drugs -- Real World Outcomes·Kanika AnandJohn-Michael Gamble
Apr 11, 2019·Psychiatric Services : a Journal of the American Psychiatric Association·Elizabeth Hisle-GormanGregory H Gorman
Dec 24, 2015·Current Psychiatry Reports·Aaron M KoenigJoel E Streim

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