981
Views
16
CrossRef citations to date
0
Altmetric
Drug Safety Evaluation

Drug safety evaluation of aripiprazole in bipolar disorder

, , , , , , , & show all
Pages 455-463 | Received 22 Aug 2018, Accepted 08 May 2019, Published online: 17 May 2019

  • Abilify. US prescribing information. [cited 2019 May 5]. Available from: https://www.otsuka-us.com/media/static/Abilify-PI.pdf?_ga=2.264923207.974101112.1534422344-1967302315.1528042378.
  • Abilify Maintena. US prescribing information. revision 03/2018, cited 2019 May 5 Available from: https://www.otsuka-us.com/media/static/Abilify-M-PI.pdf?_ga=2.12856318.834932134.1534433675-1974053279.1534433675.
  • Fagiolini A, Forgione R, Maccari M, et al. Prevalence, chronicity, burden and borders of bipolar disorder. J Affect Disord. 2013;148(2–3):161–169.
  • Kilbourne AM, Cornelius JR, Han X. at al. Bipolar Disord. 2004;6:368–373.
  • Centorrino F, Mark TL, Talamo A, et al. Health and economic burden of metabolic comorbidity among individuals with bipolar disorder. J Clin Psychopharmacol. 2009;29:595–600.
  • McIntyre RS, Konarski JZ, Yatham LN. Comorbidity in bipolar disorder: a framework for rational treatment selection. Hum Psychopharmacol. 2004;19:369–386.
  • Oswald P, Souery D, Kasper S, et al. Current issues in bipolar disorder: a critical review. Eur Neuropsychopharmacol. 2007;17:687–695.
  • Hayes JF, Miles J, Walters K, et al. A systematic review and meta-analysis of premature mortality in bipolar affective disorder. Acta Psychiatr Scand. 2015;131(6):417–425.
  • Hayes JF, Marston L, Walters K, et al. Mortality gap for people with bipolar disorder and schizophrenia: UK-based cohort study 2000–2014. Br J Psychiatry. 2017;211(03):175–181.
  • Crump C, Sundquist K, Ma W, et al. Comorbidities and mortality in bipolar disorder: a Swedish national cohort study. JAMA Psychiatry. 2013;70(9):931–939.
  • Fagiolini A, Forgione R, Maccari M, et al. Prevalence, chronicity, burden and borders of bipolar disorder. J Affect Disord. 2013 Jun;148(2–3):161–169.
  • Malhi GS, Bargh DM, McIntyre R, et al. Balanced efficacy, safety, and tolerability recommendations for the clinical management of bipolar disorder. Bipolar Disord. 2012;14(Suppl 2):1–21.
  • Li DJ, Tseng PT, Stubbs B, et al. Efficacy, safety and tolerability of aripiprazole in bipolar disorder: an updated systematic review and meta-analysis of randomized controlled trials. Prog Neuropsychopharmacol Biol Psychiatry. 2017;79(Pt B):289–301.
  • Briles JJ, Rosenberg DR, Brooks BA, et al. Review of the safety of second-generation antipsychotics: are they really “atypically” safe for youth and adults? Prim Care Companion CNS Disord. 2012;14(3):PCC.11r01298.
  • McIntyre RS, Soczynska JK, Woldeyhannes HO. Aripiprazole: pharmacology and evidence in bipolar disorder. Expert Opin Pharmacother. 2007;8(7):1001–1009.
  • Pae C. A review of the safety and tolerability of aripiprazole. Expert Opin Drug Saf. 2009;8(3):373–386.
  • McIntyre RS, Yoon J, Jerrell JM, et al. Aripiprazole for the maintenance treatment of bipolar disorder: a review of available evidence. Neuropsychiatr Dis Treat. 2011;7:319–323.
  • Casey AB, Canal CE. Classics in chemical neuroscience: aripiprazole. ACS Chem Neurosci. 2017;8(6):1135–1146.
  • Di Sciascio G. Riva MA Aripiprazole: from pharmacological profile to clinical use. Neuropsychiatr Dis Treat. 2015;11:2635–2647.
  • De Bartolomeis A, Tomasetti C, Iasevoli F. Update on the mechanism of action of aripiprazole: translational insights into antipsychotic strategies beyond dopamine receptor antagonism. CNS Drugs. 2015;29:773–799.
  • Chen JX, Su Y, Bian QT, et al. Adjunctive aripiprazole in the treatment of risperidone-induced hyperprolactinemia: A randomized, double-blind, placebo-controlled, dose–response study. Psychoneuroendocrinology. 2015;58:130–140.
  • Raghuthaman G, Venkateswaran R, Krishnadas R. Adjunctive aripiprazole in risperidone-induced hyperprolactinaemia: double-blind, randomised, placebo-controlled trial. BJPsych Open. 2015;1(2):172–177.
  • Zhao J, Song X, Ai X, et al. Adjunctive aripiprazole treatment for risperidone-induced hyperprolactinemia: an 8-week randomized, open-label, comparative clinical trial. Plos One. 2015;10(10):e0139717.
  • Davies MA, Sheffler DJ Roth BL Aripiprazole: a novel atypical antipsychotic drug with a uniquely robust pharmacology. CNS Drug Rev. 2004 Winter;10(4):317–336.
  • Leggio GM, Salomone S, Bucolo C, et al. Dopamine D(3) receptor as a new pharmacological target for the treatment of depression. Eur J Pharmacol. 2013;5, 719(1–3):25–33.
  • McIntyre RS. Konarski JZ Tolerability profiles of atypical antipsychotics in the treatment of bipolar disorder. J Clin Psychiatry. 2005;66(Suppl 3):28–36.
  • Abilify. European medicines agency. summary of product characteristics. cited 2019 May 4 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000471/WC500020170.pdf
  • Tsai CJ, Yu YH, Chiu HJ, et al. The quantitative detection of aripiprazole and its main metabolite by using capillary-electrophoresis. J Chin Med Assoc. 2011 Jun;74(6):267–271.
  • Abilify Maintena. European medicines agency. Summary of product characteristics.cited 2019 May 4 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002755/WC500156105.pdf
  • Citrome L, Macher JP, Salazar DE, et al. Pharmacokinetics of aripiprazole and concomitant carbamazepine. J Clin Psychopharmacol. 2007;27(3):279–283.
  • Fagiolini A, Nitti M, Forgione RN, et al. Aripiprazole for the treatment of bipolar disorder: a review of current evidence. Expert Opin Pharmacother. 2011;12(3):473–488.
  • Chen JX, Su YA, Bian QT, et al. Adjunctive aripiprazole in the treatment of risperidone-induced hyperprolactinemia: A randomized, double-blind, placebo-controlled, dose–response study. Psychoneuroendocrinology. 2015;58:130–140.
  • Byerly MJ, Marcus RN, Tran QV, et al. Effects of aripiprazole on prolactin levels in subjects with schizophrenia during cross-titration with risperidone or olanzapine: analysis of a randomized, open-label study. Schizophr Res. 2009 Feb;107(2–3):218–222.
  • Sogawa R, Shimomura Y, Minami C, et al. Aripiprazole-associated hypoprolactinemia in the clinical setting. J Clin Psychopharmacol. 2016;36(4):385–387.
  • Safer DJ, Calarge CA, Safer AM. Prolactin serum concentrations during aripiprazole treatment in youth. J Child Adolesc Psychopharmacol. 2013;23:282–289.
  • Propst AJ, Jarvis GE, Margolese HC. Aripiprazole-induced hypoprolactinemia in an adult male with first episode psychosis. Clin Schizophr Relat Psychoses. 2016;9:173–176.
  • Zimbroff DL, Marcus RN, Manos G, et al. Management of acute agitation in patients with bipolar disorder: efficacy and safety of intramuscular aripiprazole. J Clin Psychopharmacol. 2007;27:171–176.
  • American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care 2004;27:596–601.
  • Muneer A. The treatment of adult bipolar disorder with aripiprazole: a systematic review. Cureus. 2016 Apr 7;8(4):e562.
  • McQuade RD, Marcus R, Sanchez R, et al. Aripiprazole versus placebo in acute mania: safety and tolerability pooled analysis. Poster presented at the 5th International Conference on Bipolar Disorder. Pittsburgh, PA; 2003 June 12–14
  • Casey DE, Carson WH, Saha AR, et al. Switching patients to aripiprazole from other antipsychotic agents: a multi-center randomized study. Psychopharmacology (Berl). 2003;166:391–399.
  • Casey DE. Tardive dyskinesia and atypical antipsychotic drugs. Schizophr Res. 1999;35(Suppl):S61–6.).
  • Woods SW, Morgenstern H, Saksa JR, et al. Incidence of tardive dyskinesia with atypical versus conventional antipsychotic medications: a prospective cohort study. J Clin Psychiatry. 2010;71(4):463–474.
  • Macaluso M, Flynn A, Preskorn S. Determining whether a definitive causal relationship exists between aripiprazole and tardive dyskinesia and/or dystonia in patients with major depressive disorder, part 4: case report data. J Psychiatr Pract. 2016 May;22(3):203–220.
  • Kang NR, Kim MD. Tardive dyskinesia: treatment with aripiprazole. Clin Psychopharmacol Neurosci. 2011;9:1–8.
  • Osorio RS, Agüera-Ortiz L, Hurtado de Mendoza A, et al. Treatment of tardive dyskinesia with aripiprazole. Neurotoxic Res. 2010;17:432–434.
  • Peña MS, Yaltho TC, Jankovic J. Tardive dyskinesia and other movement disorders secondary to aripiprazole. Mov Disord. 2011;26:147–152.
  • Rajarethinam R, Dziuba J, Manji S, et al. Use of aripiprazole in tardive dyskinesia: an open label study of six cases. World J Biol Psychiatry. 2009;10:416–419.
  • Kang NR, Kim MD. Tardive dyskinesia: treatment with aripiprazole. Clin Psychopharmacol Neurosci. 2011;9:1–8.
  • Goyal R, Devi SH. A case of aripiprazole induced tardive dyskinesia in a neuroleptic-naïve patient with two years of follow up. Clin Psychopharmacol Neurosci. 2014;12:69–71.
  • Abbasian C, Power P. A case of aripiprazole and tardive dyskinesia. J Psychopharmacol. 2009;23:214–215.
  • Heitzmann E, Javelot H, Michel B. A case of aripiprazole-induced tardive dyskinesia with dramatic evolution. Case Rep Psychiatry. 2016;2016:7031245.
  • Tomruk NB, Saatcioglu O, Yildizhan E, et al. Aripiprazole-induced tardive dyskinesia treated with quetiapine: a case report. Acta Neuropsychiatr. 2011;23(4):188–190.
  • Aguilar L, Lorenzo C, Fernández-Ovejero R, et al. Tardive dyskinesia after aripiprazole treatment that improved with tetrabenazine, clozapine, and botulinum toxin. Front Pharmacol. 2019 Mar;20(10):281.
  • Sato K, Yoshida K, Higuchi H. Probable aripiprazole-induced tardive writer’s cramp. J Neuropsychiatry Clin Neurosci. 2012;24(3): article E44. PubMed] [Google Scholar].
  • Alexander J, Bickerstaff S. Aripiprazole induced tardive dyskinesia—accruing evidence. Aust N Z J Psychiatry. 2013;47(3):289–290.
  • Doval N, Das S. Moun V aripiprazole in tardive dyskinesia: is it a safe choice? J Neurosci Rural Pract. 2017 April-June;8(2):294–295.
  • Wang LJ, Ree SC, Chen CK. Courses of aripiprazole-associated tardive dyskinesia: report of two cases. Prog Neuropsychopharmacol Biol Psychiatry. 2009;33:743–744. PubMed: 19344742
  • Maeda K, Lerdrup L, Sugino H, et al. Brexpiprazole II: antipsychotic-like and procognitive effects of a novel serotonin-dopamine activity modulator. J Pharmacol Exp Ther. 2014 Sep;350(3):605–614.
  • Das S, Barnwal P, Winston B, et al. Brexpiprazole: so far so good. Ther Adv Psychopharmacol. 2016;6(1):39–54.
  • Fleischhacker W. Aripiprazole. Expert Opin Pharmacother. 2005;6:2091–2101.
  • Keck PE Jr, Calabrese JR, McQuade RD, et al. Aripiprazole study group. A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder. J Clin Psychiatry. 2006;67(4):626–637.
  • Keck PE Jr, Calabrese JR, McIntyre RS, et al. Aripiprazole monotherapy for maintenance therapy in bipolar I disorder: a 100-week, double-blind study versus placebo. J Clin Psychiatry. 2007 Oct;68(10):1480–1491.
  • Keck PE, Orsulak PJ, Cutler AJ, et al. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placebo- and lithium-controlled study. J Affect Disord. 2009 Jan;112(1–3):36–49.
  • Woo YS, Bahk WM, Chung MY, et al. Aripiprazole plus divalproex for recently manic or mixed patients with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind maintenance trial. Hum Psychopharmacol. 2011;26(8):543–553.
  • Vieta E, Owen R, Baudelet C, et al. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485–1496.
  • Vieta E, T’joen C, McQuade RD, et al. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316–1325.
  • Marcus R, Khan A, Rollin L, et al. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord. 2011;13(2):133–144.
  • Hebbrecht K, Morrens M, Neels H, et al. Pharmacokinetic evaluation of the aripiprazole (once-monthly) injection for the treatment of bipolar disorder. Expert Opin Drug Metab Toxicol. 2018 Oct;14(10):999–1005.
  • Calabrese JR, Sanchez R, Jin N, et al. Efficacy and safety of aripiprazole once-monthly in the maintenance treatment of bipolar I disorder: a double-blind, placebo-controlled, 52-week randomized withdrawal study. J Clin Psychiatry. 2017;78(3):324–331.
  • Cuomo A, Goracci A, Fagiolini A. Aripiprazole use during pregnancy, peripartum and lactation. A systematic literature search and review to inform clinical practice. J Affect Disord. 2018;228:229–237.
  • Bellet F, Beyens MN, Bernard N, et al. Exposure to aripiprazole during embryogenesis: a prospective multicenter cohort study. Pharmacoepidemiol Drug Saf. 2015;24:368–380.
  • Paulus W. Is the use of aripiprazole safe during first trimester of pregnancy? Reprod. Toxicol. 2013;37(87):2013.
  • Gildengers AG, Mulsant BH, Begley AE, et al. A pilot study of standardized treatment in geriatric bipolar disorder. Am J Geriatr Psychiatry. 2005;13(4):319–323.
  • Fagiolini A, Frank E, Houck PR, et al. Prevalence of obesity and weight change during treatment in patients with bipolar I disorder. J Clin Psychiatry. 2002 Jun;63(6):528–533.
  • Fagiolini A, Frank E, Scott JA, et al. Metabolic syndrome in bipolar disorder: findings from the bipolar disorder center for Pennsylvanians. Bipolar Disord. 2005 Oct;7(5):424–430.
  • Fagiolini A, Kupfer DJ, Houck PR, et al. Obesity as a correlate of outcome in patients with bipolar I disorder. Am J Psychiatry. 2003;160(1):112–117.
  • Fagiolini A, Kupfer DJ, Rucci P, et al. Suicide attempts and ideation in patients with bipolar I disorder. J Clin Psychiatry. 2004 Apr;65(4):509–514.
  • La Torre D. Falorni A pharmacological causes of hyperprolactinemia. Ther clin risk manag. 2007;3(5):929–951.
  • Kinon BJ, Gilmore JA, Liu H, et al. Hyperprolactinemia in response to antipsychotic drugs; characterization across comparative clinical trials. Psychoneuroendocr. 2003;28(Suppl 2):S69–82.
  • Halbreich U, Kahn LS. Hyperprolactinemia and schizophrenia: mechanisms and clinical aspects. J Psychiatr Pract. 2003;9:344–353.
  • Halbreich U, Kinon BJ, Gilmore JA. Elevated prolactin level in patients with schizophrenia. Mechanisms and related adverse effects. Psychoneuroendocr. 2003;28(Suppl 1):53–67.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.