Skip to main content Accessibility help
×
Home
Hostname: page-component-768dbb666b-vkhs7 Total loading time: 0.601 Render date: 2023-02-02T09:41:47.253Z Has data issue: true Feature Flags: { "useRatesEcommerce": false } hasContentIssue true

Safety Considerations in Pharmacotherapy of Bipolar Disorder

Published online by Cambridge University Press:  07 November 2014

Abstract

Bipolar disorder is a chronic, frequently relapsing illness with a prevalence of 1.2% to 3.4% in the general population. It is associated with high disability, higher comorbidity due to medical illnesses, and significant social and economical consequences for patients, their families, and society. The episodic nature of this disease warrants rational use of medications and proper monitoring for adverse events. Various drug classes, such as mood stabilizers, antipsychotics, benzodiazepines, and antidepressants, are used for the acute and maintenance treatment of bipolar disorder. Each group of drugs is associated with wide array of adverse events and drug interactions, which are the main hurdles in treatment outcome and compliance. Common side effects seen with several agents, particularly antipsychotics, are somnolence, weight gain, extrapyramidal symptoms, dyslipidemia, type-2 diabetes, and hyperprolactinemia. Major drug interactions are seen with drugs such as carbamazepine, due to hepatic enzyme induction. Adverse effects such as somnolence are tolerability concerns and can be managed easily; others, such as diabetes mellitus, are safety concerns. It is prudent to have precise knowledge of the individual drug's side-effect profile, pharmacokinetics, and pharmacodynamics, to plan a treatment regimen. More research is needed to understand potential rish of various drugs and to devise and incorporate monitoring protocols in the treatment regimen.

Type
Research Article
Copyright
Copyright © Cambridge University Press 2004

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Goodwin, FK, Jamison, KR. Manic-Depressive Illness. New York, NY: Oxford University Press; 1990.Google ScholarPubMed
2.Murray, CL, Lopez, AD, eds. The Global Burden of Disease. Boston, Mass: Harvard University Press; 1996.Google Scholar
3.Osby, U, Brandt, L, Correla, N, et al.Excess mortality in bipolar and unipolar disorder in Sweden. Arch Gen Psychiatry. 2001;58(9):844850.CrossRefGoogle ScholarPubMed
4.Simon, GE. Social and economic burden of mood disorders. Biol Psychiatry. 2003;54:208215.CrossRefGoogle Scholar
5.Ketter, TA, Pazzaglia, PJ, Post, RM. Synergy of carbamazepine and valproic acid in affective illness: case report and review of literature. J Clin Psychopharmacol. 1992;12(4):276281.Google Scholar
6.Maj, M. The impact of lithium prophylaxis on the course of bipolar disorder: a review of the research evidence. Bipolar Disord. 2000;2:93101.CrossRefGoogle Scholar
7.Moller, HJ, Nasrallah, HA. Treatment of bipolar disorder. J Clin Psychiatry. 2003;64(Suppl 6):917.Google ScholarPubMed
8.Tohen, M, Jacobs, TG, Grundy, SL, et al.The olanzapine HGGW Study Group. Efficacy of olanzapine in acute bipolar mania: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2000;57:841849.CrossRefGoogle Scholar
9.Dube, S, Anderson, SE, Sanger, TM, et al.Olanzapine-fluoxetine combination for psychotic major depression. Poster presented at: Annual meeting of the American Psychiatric Association; 05 18-23, 2002; Philadelphia, PA.Google Scholar
10.Vieta, E, Brugue, E, Goikolea, JM, et al.Acute and continuation risperidone monotherapy in mania. Hum Psychopharmacol. 2004;19:4145.CrossRefGoogle ScholarPubMed
11.Bowden, CL, Brugger, AM, Swann, AC, et al.The Depakote Mania Study Group. Efficacy of divalproex vs lithium and placebo in the treatment of mania. JAMA. 1994;271:918924.CrossRefGoogle Scholar
12.Calabrese, JR, Bowden, CL, Sachs, GS, et al.A double-blind, placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. J Clin Psychiatry. 1999;60:7988.CrossRefGoogle ScholarPubMed
13.McElroy, SL, Keck, PE Jr. Pharmacological agents for the treatment of acute bipolar mania. Biol Psychiatry. 2000;48:539557.CrossRefGoogle Scholar
14.Weisler, RH, Kalali, AH, Ketter, TA, and the SPD417 Study Group. A multi-center, randomized, double-blind, placebo-controlled trial of extended-release carbamazepine capsules as monotherapy for bipolar disorder patients with manic or mixed episodes. J Ciin Psychiatry. In press.Google ScholarPubMed
15.Ketter, TA, Kalali, AH, Weisler, RH, and the SPD417 Study Group. A 6-month, multicenter, open-label evaluation of extended-release carbamazepine capsule monotherapy in bipolar disorder patients with manic or mixed episodes. J Ciin Psychiatry. In press.Google ScholarPubMed
16.Shire Pharmaceutical Development Inc. Data on file. Study 304, 2003.Google ScholarPubMed
17.Marcotte, D. Use of topiramate, a new antiepileptic, as a mood stabilizer. J Affect Disorl 1998;50:245251.CrossRefGoogle Scholar
18.Baldassano, CF, Ghaemi, SN, Ballas, C, et al.Adjunctive zonisamide as immediate treatment of bipolar disorder outpatients. Poster presented at: annual meeting of American Epilepsy Society; 12 6-11, 2002; Seattle, WA.Google Scholar
19.Silverstone, PH, Silverstone, T. A review of acute treatments for bipolar depression. Int Clin Pychopharmacol. 2004;19(3): 113124.CrossRefGoogle Scholar
20.Parker, G, Parker, K. Which antidepressants flick the switch? Aust N Z J Psychiatry. 2003;37(4):464468.CrossRefGoogle Scholar
21.Hirschfeld, RM, Lewis, L, Vornik, LA. Perceptions and impact of bipolar disorder: how far have we really come? Results of the national depressive and manic-depressive association 2000 survey of individuals with bipolar disorder. J Ciin Psychiatry. 2003;64:161174.Google Scholar
22.Nasrallah, HA. Factors in antipsychotic drug selection: tolerability considerations. CNS Spectr. 2003;8(11 Suppl 2):2325.CrossRefGoogle ScholarPubMed
23.Bendz, H, Aurell, M. Adverse affects of lithium treatment and safety routines. Lakaridningen. 2004;101(21-22):1902-1906, 1908.Google Scholar
24.Baldessarini, RJ. Treatment research in bipolar disorder: issues and recommendations. CNS Drugs. 2002;16(11):721729.CrossRefGoogle ScholarPubMed
25.Citrome, L. Use of lithium, carbamazepine, and valproic acid in a state-operated psychiatric hospital. J Pharm Technol. 1995;11(2):5559.CrossRefGoogle Scholar
26.Ebert, MH, Loosen, PT, Nurcombe, B. Bipolar disorder: Current Diagnosis & Treatment in Psychiatry. E-Book. New York, NY: McGraw Hill Companies; Copyright ©20022003.Google Scholar
27.Jamison, KR, Gerner, RH, Goodwin, FK. Patient and physician attitude toward lithium: relationship to compliance. Arch Gen Psychiatry. 1979;36:866869.CrossRefGoogle ScholarPubMed
28.Baptista, T, Teneud, L, Contreras, Q, et al.Lithium and body weight gain. Pharmacopsychiatry. 1995;28(2):35–34.CrossRefGoogle ScholarPubMed
29.Calabrese, JR, Bowden, CL, Sachs, G, et al.A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar 1 disorder. J Clin Psychiatry. 2003;64(9):10131024.CrossRefGoogle Scholar
30.Bowden, CL. Valproate. Bipolar Disord. 2003;5:189202.CrossRefGoogle ScholarPubMed
31.Calabrese, JR, Delucchi, GA. Spectrum of efficacy of valproate in 55 patients with rapid-cycling bipolar disorder. Am J Psychiatry. 1990;147(4):431434.Google ScholarPubMed
32. Depakon® [package insert]. North Chicago, Il: Abbott laboratories; 2000.Google Scholar
33.Macritchie, K, Geddes, JR, Scott, J, et al. Valproate (Cochrane review). Issue 4. 2004.Google Scholar
34.Holtmann, M, Krause, M, Opp, J, et al.Oxcarbazepine-induced hyponatremia and the regulation of serum sodium after replacing carbamazepine with oxcarbazepine in children. Neuropediatrics. 2002;33:298300.CrossRefGoogle ScholarPubMed
35.Ghaemi, SN, Berv, DA, Klugman, Jet al.Oxcarbazepine treatment of bipolar disorder. J Ciin Psychiatry. 2003;64(8):943945.Google ScholarPubMed
36.Mendlewicz, J, Souery, D, Rivelli, SK. Short-term and long-term treatment for bipolar patients: beyond the guidelines. J Affect Disord. 1999;55:7985.CrossRefGoogle Scholar
37. Tegretol® [package insert]: East Hanover, NJ: Novartis Pharmaceuticals Corp; 2001.Google Scholar
38.Freeman, MP, Stoll, AL. Mood stabilizer combination: a review of safety and efficacy. Am J Psychiatry. 1998; 155(1): 1221.CrossRefGoogle ScholarPubMed
39.Bowden, CL, Asnis, GM, Ginsberg, LD, et al.Safety and tolerability of lamotrigine for bipolar disorder. Drug Saf. 2004;27(3):173184.CrossRefGoogle ScholarPubMed
40.Goldsmith, DR, Wagstaff, AJ, Ibbotson, T, et al.Lamotrigine: a review of its use in bipolar disorder. Drugs. 2003;63(19):20292050.CrossRefGoogle ScholarPubMed
41.Biton, V, Mirza, W, Montouris, G, et al.Weight change associated with valproate and lamotrigine monotherapy in patients with epilepsy. Neurobgy. 2001;56(2):172177.Google ScholarPubMed
42.Bowden, CL, Calabrese, JR, McElroy, SL, et al.A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar 1 disorder. Divalproex Maintenance Study Group. Arch Gen Psychiatry. 2000;57(5):490492.CrossRefGoogle ScholarPubMed
43.Nemeroff, CB. Safety of available agents used to treat bipolar disorder: focus on weight gain. J Clin Psychiatry. 2003;64(5):532539.CrossRefGoogle ScholarPubMed
44.Suppes, T. Review of the use of topiramate for treatment of bipolar disorders. J Ciin Psychopharmacol. 2002;22(6):599609.CrossRefGoogle Scholar
45.McElroy, SL, Suppes, T, Keck, PE Jr, et al.Open-label adjunctive to topiramate in the treatment of bipolar disorders. Biol Psychiatry. 2000;47(12):10251033.CrossRefGoogle Scholar
46.Kapur, S, Zipursky, R, Jones, C, et al.Relationship between dopamine D2 occupancy, clinical response, and side effects: a double-blind PET study of first-episode schizophrenia. Am J Psychiatry. 2000;157:514520.CrossRefGoogle Scholar
47.Keck, PE Jr, Marcus, R, Tourkodimitris, S, et al.Atipiprazole Study Group. A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry. 2003;160:16511658.CrossRefGoogle Scholar
48.Kane, JM. Tardive dyskinesia rates with atypical antipsychotics in adults: prevalence and incidence. J Ciin Psychiatry. 2004;65(Suppl 9):1620.Google ScholarPubMed
49.Kane, JM, Woemer, M, Borenstein, M, et al.Integrating incidence and prevalence of tardive dyskinesia. Psychopharmacol Bull. 1986;22:254258.Google ScholarPubMed
50.Yassa, R, Nair, NP. A 10-year follow-up study of tardive dyskinesia. Acta Psychiatr Scand. 1992;86:262266.CrossRefGoogle ScholarPubMed
51.Hunt, N, Silverstone, T. Tardive dyskinesia in bipolar affective disordet: a catchment area study. Int Ciin Psychopharmacol. 1991;6:4550.CrossRefGoogle ScholarPubMed
52.Jeste, DV, Lacro, JP, Bailey, A, et al.Lower incidence of tardive dyskinesia with risperidone compared with haloperidol in older patients. J Am Geriatric Soc. 1999;47:716719.CrossRefGoogle ScholarPubMed
53.Zhang, XY, Zhou, DF, Cao, Ly, et al.The effect of vitamin E treatment on terdive dyskinesia and blood superoxide dismutase: A double-blind, placebo-controlled trial. J Clin Psychopharmacol. 2004;1:8386.CrossRefGoogle Scholar
54.Lerner, V, Miodownick, C, Kaptsan, A, et al.Vitamin B6 in the treatment of tardive dyskinesia: A double-blind, placebo-controlled, crossover study. Am J Psychiatry. 2001;158(9):15111514.CrossRefGoogle Scholar
55.Mokdad, AH, Bowman, BA, Ford, FS, et al.The continuing epidemics of obesity and diabetes in United States. JAMA. 2001;286:11951200.CrossRefGoogle ScholarPubMed
56.National Task Force on the Prevention and Treatment of Obesity. JAMA. 1996;276:19071915.CrossRefGoogle ScholarPubMed
57.Carek, PJ, Sherer, JT, Carson, DS. Management of obesity: medical treatment options. Am Fam Physician. 1997;55:551562.Google ScholarPubMed
58.Elmslie, JL, Silverstone, JT, Mann, JI, et al.Prevalence of overweight and obesity in bipolar patients. J Ciin Psychiatry. 2000;61(3):179184.Google ScholarPubMed
59.Masand, P, Gupta, S. Quality of life issues associated with antipsychotic-induced weight gain. Expert Rev. Pharmacoeconomics Outcomes Res. 2003;3(5):651659.CrossRefGoogle Scholar
60.Allison, DB, Mentore, JL, Heo, M, et al.Antipsychotic-induced weight gain: a comprehensive research synthesis. Am J Psychiatry. 1999;156:16861696.Google Scholar
61.Sachs, GS, Gtossman, F, Ghaemi, SN, et al.Combination of mood stabilizer with risperidone or haloperidol for treatment of acute mania: a double-blind, placebo-conttolled comparison of efficacy and safety. Am J Psychiatry. 2002;159(7):11461154.CrossRefGoogle Scholar
62.Marcus, RN, Carson, WH Jr, McQuade, RD, et al.Overview of safety and tolerability of atipiprazole in acute mania. Poster presented at: 157th Annual Meeting of American Psychiattic Association; 05 1-6, 2004; New Yotk, NY.Google Scholar
63.Tohen, M, Chengappa, KN, Suppes, T, et al.Efficacy of olanzapine in combination with valproate or lithium in the treatment of mania in patients partially nonresponsive to valproate or lithium monothetapy. Arch Gen Psychiatry. 2002;59(1):6269.CrossRefGoogle ScholarPubMed
64.Vieta, E, Sanchez-Moreno, J, Golkelia, JM, et al.Effects on weight and outcome of long-term olanzapine-topiramate combination treatment in bipolar disorder. J Clin Psychopharmacol. 2004;24(4):374378.CrossRefGoogle ScholarPubMed
65.Keck, PE, Potkin, SG, Giller, E Jr, et al.Ziprasidone's long-term efficacy and safety in bipolar disorder. Poster presented at: 157th Annual Meeting of American Psychiatric Association; 05 1-6, 2004; New Yotk, NY.Google Scholar
66.Caballero, E. Obesity, diabetes, and the metabolic syndrome: New challenges in antipsychotic drug therapy. CNS Spectr. 2003;8(11 Suppl 2):1922.CrossRefGoogle Scholar
67.Merz, CN, Buse, JB, Tuncer, D, Twillman, GB. Physician attitudes and practices and patient awareness of the cardiovascular complications of diabetes. J Am Coll Cardiol. 2002;40:18771881.CrossRefGoogle Scholar
68.Btown, WV. Risk factots for vascular disease in patients with diabetes. Diabetes Obes Metab. 2000;2(Suppl):S11S18Google Scholar
69.Reaven, GM. Pathophysiology of insulin resistance in human disease. Physiol Rev. 1995;75:473486.Google ScholarPubMed
70.Ryall, RW. Some actions of chlorpromazine. Br J Pharmacol 1956;11(3):339345.Google ScholarPubMed
71.Gupta, S, Lentz, B, Lockwood, K, et al.Atypical antipsychotics and glucose dysregulation: a series of 4 cases. Prim Care Companion J Clin Psychiatry. 2001;3(2):6165.CrossRefGoogle Scholar
72.Ratzoni, G, Gothelf, D, Brand-Gothelf, A, et al.Weight gain associated with olanzapine and risperidone in adolescent patients: a comparative prospective study. J Am Acad Child Adoiesc Psychiatry. 2002;41(3):337343.CrossRefGoogle ScholarPubMed
73.Click, ID, Romano, SJ, Simpson, G, et al.Insulin tesistance in olanzapine and ziprasidone treated patients: results of a double-blind, controlled 6-week trial. Poster presented at: 154th Annual Meeting of the American Psychiatric association; 05 7-11, 2001; New Orleans, La.Google Scholar
74.Koller, EA, Weber, J, Doraiswamy, PM, et al.A survey of reports of quetiapine-associated hypetglycemia and diabetes mellitus. J Clin Psychiatry. 2004;65(6):587863.CrossRefGoogle ScholarPubMed
75.Kollet, EA, Cross, JT, Doraiswamy, PM, et al.Risperidone-associated diabetes mellitus: a pharmacovigilance study. Pharmacotherapy. 2003;23:735744.CrossRefGoogle Scholar
76.Koller, EA, Doraiswamy, PM. Olanzapine-associated diabetes mellitus. Pharmacotherapy. 2002;22:841852.CrossRefGoogle Scholar
77.Lindenmayer, JP, Czobor, P, Volavka, J, et al.Changes in glucose and cholesterol levels in patients with schizophrenia treated with typical and atypical antipsychotics. Am J Psychiatry. 2003;160:290296.CrossRefGoogle ScholarPubMed
78.Ametican Diabetes Association; American Psychiatric Association; Ametican 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(2):596601.Google Scholar
79.Wieck, A, Haddad, PM. Antipsychotic-induced hyperprolactinemia in women: pathophysiology, severity and consequences. Selective literature review. Br J Psychiatry. 2003;182:199204.CrossRefGoogle ScholarPubMed
80.Keck, PE Jr, Sanchez, R, Marcus, RN, et al.Atipiprazole for relapse prevention in bipolar disorder in 26-week trial. Postet presented at: 157th Annual Meeting of American Psychiatric Association; 05 1-6, 2004; New Yotk, NY.Google ScholarPubMed
81.Hennessy, S, Bilker, WB, Santanna, JC, et al.Cardiac arrest risk appears to vary little by choice of antipsychotic drug. Postet presented at: Annual Meeting of American Psychiatric Association; 05 7-11, 2001; New Orleans, La.Google Scholar
82.FDA Psychopharmacological Drug Advisory Committee. Pfizer study 54-07 19, 2000.Google Scholar
83.Funck-Brentano, C, Jailon, P. Rate-corrected QT interval: techniques and limitations. Am J Cardiol. 1993;72:178228.CrossRefGoogle Scholar
84.Gupta, S, Masand, PS, Gupta, S. Cardiovascular side effects of novel antipsychotics. CNS Spectr. 2001;6(11):912918.CrossRefGoogle ScholarPubMed
5
Cited by

Save article to Kindle

To save this article to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Safety Considerations in Pharmacotherapy of Bipolar Disorder
Available formats
×

Save article to Dropbox

To save this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you used this feature, you will be asked to authorise Cambridge Core to connect with your Dropbox account. Find out more about saving content to Dropbox.

Safety Considerations in Pharmacotherapy of Bipolar Disorder
Available formats
×

Save article to Google Drive

To save this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you used this feature, you will be asked to authorise Cambridge Core to connect with your Google Drive account. Find out more about saving content to Google Drive.

Safety Considerations in Pharmacotherapy of Bipolar Disorder
Available formats
×
×

Reply to: Submit a response

Please enter your response.

Your details

Please enter a valid email address.

Conflicting interests

Do you have any conflicting interests? *