Lithium in pregnancy: The need to treat, the duty to ensure safety

Expert Opinion on Drug Safety

Volumn 11, Issue 3, 2012, Pages 425-437

  Gentile, Salvatore ^a  

^a Mental Health Center   (Italy)

Author keywords

Bipolar disorder; Lithium; Perinatal complications; Pregnancy; Teratogenicity

Indexed keywords

ACETYLCHOLINESTERASE; ALPHA FETOPROTEIN; FOLIC ACID; LAMOTRIGINE; LITHIUM; LITHIUM ACETATE; LITHIUM CITRATE; NEUROLEPTIC AGENT;

AMNION FLUID; AORTA COARCTATION; BIPOLAR DISORDER; BODY TEMPERATURE DISORDER; BRADYCARDIA; BREAST FEEDING; CYANOSIS; DEXTROCARDIA; DIABETES INSIPIDUS; DISEASE ASSOCIATION; DRUG BLOOD LEVEL; DRUG BRAIN LEVEL; DRUG MONITORING; DRUG SAFETY; EBSTEIN ANOMALY; ECHOCARDIOGRAPHY; ECTOPIC THYROID GLAND; FIRST TRIMESTER PREGNANCY; GLOMERULUS FILTRATION RATE; GOITER; HEART ATRIUM FLUTTER; HEART ATRIUM SEPTUM DEFECT; HEART VENTRICLE SEPTUM DEFECT; HEPATOMEGALY; HUMAN; HYDRAMNIOS; HYDROCEPHALUS; HYPERBILIRUBINEMIA; HYPOGLYCEMIA; INCIDENCE; INFORMED CONSENT; LARGE FOR GESTATIONAL AGE; LETHARGY; MACROSOMIA; MAXILLA HYPOPLASIA; MENINGOMYELOCELE; MEROMELIA; METABOLIC ACIDOSIS; MICROTIA; MITRAL VALVE ATRESIA; MITRAL VALVE STENOSIS; MUSCLE HYPOTONIA; NEPHROGENIC DIABETES INSIPIDUS; NEURAL TUBE DEFECT; NEVUS FLAMMEUS; PATENT DUCTUS ARTERIOSUS; PERINATAL ASPHYXIA; PERINATAL MORTALITY; PERSISTENT PULMONARY HYPERTENSION; PES EQUINOVARUS; PREGNANCY OUTCOME; PREMATURE LABOR; PREMATURITY; PRENATAL DIAGNOSIS; PRENATAL DRUG EXPOSURE; PSYCHOPHARMACOTHERAPY; RESPIRATORY FUNCTION DISORDER; REVIEW; RISK FACTOR; SIDE EFFECT; SINGLE UMBILICAL ARTERY; SLEEP WAKING CYCLE; STILLBIRTH; SUPRAVENTRICULAR TACHYCARDIA; SYSTEMATIC REVIEW; SYSTOLIC HEART MURMUR; TACHYPNEA; TERATOGENICITY; TRICUSPID VALVE ATRESIA;

ABNORMALITIES, DRUG-INDUCED; ANTIMANIC AGENTS; BIPOLAR DISORDER; EVIDENCE-BASED MEDICINE; FEMALE; HUMANS; LITHIUM COMPOUNDS; PATIENT SAFETY; PRACTICE GUIDELINES AS TOPIC; PREGNANCY; PRENATAL EXPOSURE DELAYED EFFECTS; RISK ASSESSMENT; RISK FACTORS; TREATMENT OUTCOME;

EID: 84860212499     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2012.670419     Document Type: Review

References (100)

1. Kessler RC, Chiu WT, Demler O, et al. Prevalence, severity, and comorbidity of 12-month DSM IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry 2005;62:617-27 (Pubitemid 40973437)
2. Suominen K, Mantere O, Valtonen H, et al. Gender differences in bipolar disorder type I and II. Acta Psychiatr Scand 2009;120:464-73
3. Yonkers KA, Wisner KL, Stowe ZN, et al. Management of bipolar disorder during pregnancy and the postpartum period. Am J Psychiatry 2004;161:608-20 (Pubitemid 38445503)
4. Gentile S. Prophylactic treatment of bipolar disorder in pregnancy and breastfeeding: focus on emerging mood stabilizers. Bipolar Disord 2006;8:207-20
5. Yonkers KA, Wisner KL, Steward DE, et al. Typical somatic symptoms of pregnancy and their impact on a diagnosis of major depressive disorder. Gen Hosp Psychiatry 2009;3:327-33
6. Gentile S. The safety of new mood stabilizers in pregnancy and lactation [Abstract]. Eur Neuropsychopharmacol 2004;14(Suppl 3):S324
7. Viguera AC, Whitfield T, Baldessarini RJ, et al. Risk of recurrence in women with bipolar disorder during pregnancy: prospective study of mood stabilizer discontinuation. Am J Psychiatry 2007;164:1817-24 (Pubitemid 351739234)
8. Gentile S. Managing the suicidal risk in pregnant women with severe and persistent psychiatric disorder. Focus on antisuicidal drugs and somatic interventions. Curr Psychiatry Rev 2008;4:169-84
9. Gentile S. Antipsychotic therapy during early and late pregnancy. A systematic review. Schizophr Bull 2010;36:518-44
10. Gentile S. Schizoaffective disorder in women with childbearing potential: focus on treatment with newer and emerging mood stabilizers. In: Murray WH, editor. Schizoaffective Disorder: New research. Nova Publishers, New York, 2006. p. 187-220
11. Yonkers KA, Wisner KL, Stewart DE. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Gen Hosp Psychiatry 2009;31:403-13
12. Demler TL. Labeling guidelines for antipsychotics during pregnancy. Available from: http://www.uspharmacist. com/content/c/31079/[Accessed: 20 January 2011]
13. Donald B. Davis Drugs in Pregnancy-The Issues for 2010-. J Popul Ther Clin Pharmacol 2010;17:e331-5
14. Kessing LV, Hellmund G, Geddes JR, et al. Valproate v. lithium in the treatment of bipolar disorder in clinical practice: observational nationwide register-based cohort study. Br J Psychiatry 2011;199:57-63
15. Diav-Citrin O, Shechtman S, Bar-Oz B, et al. Pregnancy outcome after in utero exposure to valproate: evidence of dose relationship in teratogenic effect. CNS Drugs 2008;22:325-34 (Pubitemid 351367441)
16. Meador KJ, Baker GA, Browning N, et al. Cognitive function at 3 years of age after fetal exposure to antiepileptic drugs. N Engl J Med 2009;360:1597-605
17. Bromley RL, Mawer G, Clayton-Smith J, Baker GA; Liverpool and Manchester Neurodevelopment Group. Autism spectrum disorders following in utero exposure to antiepileptic drugs. Neurology 2008;71:1923-4
18. U.S Food and Drug Administration. Lamotrigine (marketed as Lamictal)-Healthcare Professional Sheet text version. Available from: http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm126225.htm [Accessed 23 July 2009]
19. Dolk H, Jentink J, Loane M, et al. EUROCAT Antiepileptic Drug Working Group. Does lamotrigine use in pregnancy increase orofacial cleft risk relative to other malformations? Neurology 2008;71:714-22
20. Calabrese JR, Suppes T, Bowden CL, et al. A double-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder. Lamictal 614 Study Group. J Clin Psychiatry 2000;61:841-50
21. Connolly KR, Thase ME. The clinical management of bipolar disorder: a review of evidence-based guidelines. Prim Care Companion CNS Disord 2011;13:pii-PCC. 10r01097
22. Newport DJ, Stowe ZN, Viguera AC, et al. Lamotrigine in bipolar disorder: efficacy during pregnancy. Bipolar Disord 2008;10:432-6 (Pubitemid 351522668)
23. Gentile S. The clinical utilization of atypical antipsychotics in pregnancy and lactation. Ann Pharmacother 2004;38:1265-71 (Pubitemid 38802173)
24. Gentile S. Long term atypical antipsychotics treatment and risk of weight gain. A literature analysis. Drug Saf 2006;29:303-19
25. Waller DK, Shaw GM, Rasmussen AS, et al. Prepregnancy obesity as a risk factor for structural birth defects. Arch Pediatr Adolesc Med 2007;161:745-50 (Pubitemid 47236440)
26. MGH Center for Women's Mental Health. New FDA warning on the use of antipsychotic medications in pregnancy. Available from: http://www. womensmentalhealth.org/posts/new-fda-warning-on-the-use-of-antipsychotic- medications-in-pregnancy/[Accessed 20 January 2011]
27. Gentile S. Atypical antipsychotic for the treatment of bipolar disorder. More shadows than lights. CNS Drugs 2007;21:367-87 (Pubitemid 46705301)
28. Gentile S. The safety of mood stabilizing medication in pregnancy and lactation [Abstract]. World J Biol Psychiatry 2009;10(Suppl 1):87
29. Briggs GG, Freeman RK, Jaffe SJ. editors. Lithium. In: Drugs in Pregnancy and Lactation. A Reference Guide to Fetal and Neonatal Risk. Williams & Wilkins; Philadelphia: 2005. p. 929-34
30. Diav-Citrin O, Shechtman S, Tahover E, et al. Pregnancy outcome after in-utero exposure to lithium: a prospective controlled study. Abstract presented in the 46th annual meeting of the American Teratology Society; June 1996; Tucson, Arizona
31. Van Gent EM, Verhoeven WMA. Bipolar illness, lithium prophylaxis, and pregnancy. Pharmacopsychiatry 1992;25:187-91
32. Jacobson SJ, Jones K, Johnson K, et al. Prospective multicentre study of pregnancy outcome after lithium exposure during first trimester. Lancet 1992;339:530-3
33. Cuniff CH, Sahn DJ, Reed KL, et al. Pregnancy outcome in patients treated with lithium [abstract]. Teratol Soc Abstr 1989;39:447-8
34. Schou M, Goldfield MD, Weinstein MR, et al. Lithium and pregnancy-I, report from the Register of lithium Babies. Br Med J 1973;2:135-6
35. Weinstein MR, Goldfield MD. Cardiovascular malformations with lithium use during pregnancy. Am J Psychiatry 1975;132:529-30
36. Schou M. Lithium treatment during pregnancy, delivery, and lactation: un update. J Clin Psychiatry 1990;51:410-13 (Pubitemid 20359848)
37. Schou M. What happened later to lithium babies? A follow-up study of children born without malformations. Acta Psychiatr Scand 1976;54:193-7
38. Nora JJ, Nora AH, Toews WH. Lithium, Ebstein's anomaly, and other congenital hearth defects [Letter]. Lancet 1974;9:594-5
39. Kallen B, Tandberg A. Lithium and pregnancy. A cohort study on manic-depressive women. Acta Psychiatr Scand 1983;68:134-9 (Pubitemid 13038250)
40. Kramer A, Knoppert-Vander Klein BAM, Van Kamp IL, et al. Bipolar and pregnant? No problem! A clinical evaluation of lithium use during pregnancy [Abstract]. Eur Neuropsychopharmacol 2003;13:S246
41. Lisi A, Botto LD, Robert-Gnansia E, et al. Surveillance of Adverse Fetal Effects of Medications (SAFE-Med): findings from the international clearinghouse of birth defects surveillance and research. Reprod Toxicol 2010;29:433-42
42. van der Lugt NM, van de Maat JS, van Kamp IL, et al. Fetal, neonatal and developmental outcomes of lithium-exposed pregnancies. Early Hum Dev 2011; Epub ahead of print
43. Zalstein E, Koren G, Einarson T, Freedom RM. A case-control study on the association between first trimester exposure to lithium and Ebstein's anomaly. Am J Cardiol 1990;63:817-18 (Pubitemid 20093413)
44. Edmonds LD, Oakley GP. Ebstein's anomaly and maternal lithium exposure during pregnancy [abstract]. Teratology 1990;41:551-2
45. Warkanj J. Teratogen update: lithium. Teratology 1988;38:593-6
46. Sipek A. Lithium and Ebstein's anomaly. Cor Vasa 1989;31:149-56
47. Czeizel A, Racz J. Evaluation of drug intake during pregnancy in the Hungarian case-control surveillance of congenital anomalies. Teratology 1990;42:505-12 (Pubitemid 20383739)
48. Kallen B. Comments on teratogen update: lithium. Teratology 1988;38:597
49. Schou M. Special review: lithium in psychiatric therapy and prophylaxis. J Psychiatr Res 1968;6:67
50. Rane A, Tomson G, Bjarke B. Effects of neonatal lithium therapy in a newborn infant. J Pediatr 1978;93:296-7 (Pubitemid 8380053)
51. O'Donovan P, O'Herlihy C, Roystan D. Hydrops fetalis and congenital mitral stenosis associated with maternal lithium treatment. J Obstet Gynecol 1984;5:101 (Pubitemid 14009024)
52. Long WA, Willis PW. Maternal lithium therapy and neonatal Ebstein's anomaly; evaluation with cross-sectional echocardiography. Am J Perinatol 1984;1:182-4 (Pubitemid 14095495)
53. Park JM, Sridaromont S, Ledbetter EO, et al. Ebstein's anomaly of the tricuspid valve associated with prenatal exposure to lithium carbonate. Am J Dis Child 1980;34:703-4
54. Robert E, Francannet C. Comment on "Teratogen update on lithium by J. Warkany" [Letter]. Teratology 1990;42:205 (Pubitemid 20292030)
55. Leung AC. Port-wine stain associated with maternal use of lithium carbonate. J Nat Med Assoc 1987;79:877-8
56. Tekin M, Ellison J. Oromandibular-limb hypogenesis spectrum and maternal lithium use. Clin Dismorphol 2000;9:139-71
57. Grover S, Gupta N. Lithium-associated anencephaly [Letter]. Can J Psychiatry 2005;50:185-6
58. Aoki FY, Ruedy J. Severe lithium intoxication: management without dialysis and report of a possible teratogenic effect of lithium. CMAJ 1971;105:847-8
59. Khandelwal SK, Sagar RS, Saxena S. Lithium in pregnancy and still birth: a case report. Br J Psychiatry 1989;154:116-18
60. Fries H. Lithium in pregnancy [Letter]. Lancet 1970;6:1233
61. Burt VK, Bernstein C, Rosenstein WS, et al. Bipolar disorder and pregnancy: maintaining psychiatric stability in the real world of obstetric and psychiatric complications. Am J Psychiatry 2010;167:892-7
62. Ramikisson R, Campbell M, Agius M. The clinical dilemma: prescribing in pregnancy. Psychiatr Danub 2008;20:88-90
63. Newport JD, Viguera AC, Beach AJ, et al. Lithium placental passage and obstetrical outcome: implications for clinical management during late pregnancy. Am J Psychiatry 2005;162:2162-70 (Pubitemid 41598272)
64. Troyer WA, Pereira GR, Lannon RA, et al. Association of maternal lithium exposure and premature delivery. J Perinatol 1993;13:123-7
65. Yoder MC, Belik A, Lannon RA, et al. Infants of mothers treated with lithium (Li) during pregnancy have an increased incidence of prematurity, macrosomia, and perinatal deaths [abstract]. Pediatr Res 1984;18:163A
66. Stevens D, Burnam D, Midwinter A. Transplacental lithium poisoning [Letter]. Lancet 1974;2:595
67. Wilson N, Forfar JC, Godman MJ. Atrial flutter in the newborn resulting from maternal lithium ingestion. Arch Dis Child 1983;58:538-49
68. Zeger B, Andriessen P. Maternal lithium therapy and neonatal morbidity. Eur J Pediatr 2003;162:348-9 (Pubitemid 36577828)
69. Khozma C. Neonatal toxicity and transient neurodevelopmental deficits following prenatal exposure to lithium. Another clinical report and a review of the literature. Am J Med Genet A 2005;132A:441-4
70. Arnon RC, Marin-Garcia J, Peeden JN. Tricuspid valve regurgitation and lithium carbonate toxicity in a newborn infant. Am J Dis Child 1981;135:941-3 (Pubitemid 11027140)
71. Ang MS, Thorp JA, Parisi VM. Maternal lithium therapy and polyhydramnios. Obstet Gynecol 1990;76:517-20
72. Mizrahi EM, Hobbs JF, Goldsmith DI. Nephrogenic diabetes insipidus in transplacental lithium intoxication. J Pediatr 1979;94:493-5 (Pubitemid 9111109)
73. Krause S, Ebbesen F, Lange AP. Polyhydramnios associated with maternal lithium treatment. Obstet Gynecol 1990;75:504-6 (Pubitemid 20062312)
74. Pinelli JM, Symington AJ, Cunningham KA, et al. Case report and review of the perinatal implications of maternal lithium use. Am J Obstet Gynecol 2002;187:245-9 (Pubitemid 34800332)
75. Stothers JK, Wilson DW, Royston N. Lithium toxicity in the newborn [Letter]. Br Med J 1973;3:233-4
76. Malzacher A, Engler H, Drack G, et al. Lethargy in a newborn: lithium toxicity or lab error? J Perinat Med 2003;31:340-2 (Pubitemid 36988205)
77. Tunnessen WW, Hertz CG. Toxic effects of lithium in newborn infants. A commentary. J Pediatr 1972;81:804-7
78. Sykes PA, Quarrie J, Alexander FW. Lithium carbonate and breastfeeding. Br Med J 1976;2:1299
79. Nars PW, Girard J. Lithium carbonate intake during pregnancy leading to large goiter in a premature infant. Am J Dis Child 1977;131:924-5 (Pubitemid 8165744)
80. Karlsson K, Lindsted G, Lundberg PA, et al. Transplacental lithium poisoning: reversible inhibition of fetal thyroid [Letter]. Lancet 1975;1:1295
81. Silverman JA, Winters RW, Strande C. Lithium carbonate therapy during pregnancy: apparent lack of effect upon the fetus. Am J Obstet Gynecol 1971;109:934-6
82. Connoley G, Menahem S. A possible association between neonatal jaundice and long-term maternal lithium ingestion. Med J Aust 1990;152:272-3 (Pubitemid 20120528)
83. Wilbanks GD, Bressler B, Peete CH Jr, et al. Toxic effects of lithium carbonate in a mother and newborn infant. JAMA 1970;213:865-7
84. Flaherty B, Krenzelok EP. Neonatal lithium toxicity as a result of maternal toxicity. Vet Hum Toxicol 1997;39:92-3 (Pubitemid 27143464)
85. Nishiwaki T, Tanaka K, Sekiya S. Acute lithium intoxication in pregnancy [Letter]. Int J Gynaecol Obstet 1996;52:191-2 (Pubitemid 26039249)
86. Blake LD, Lucas DN, Aziz K, et al. Lithium toxicity and the parturient: case report and literature review. Int J Obstet Anesth 2008;17:164-9 (Pubitemid 351381432)
87. Woody JN, London WL, Wilbanks GD. Lithium toxicity in a newborn. Pediatrics 1971;47:94-6
88. Morrell P, Sutherland GR, Buamah PK, et al. Lithium toxicity in a neonate. Arch Dis Child 1983;58:539-41 (Pubitemid 13072481)
89. Filtenborg JA. Persistent pulmonary hypertension after lithium intoxication in the newborn. Eur J Pediatr 1982;138:321-3 (Pubitemid 12041561)
90. Mackay AVP, Loose R, Glen AIM. Labor on lithium. Br Med J 1976;4:878
91. Mallinger AG, Hanin I, Stumpf R, et al. Lithium treatment during pregnancy: a case study of erythrocyte choline content and lithium transport. J Clin Psychiatry 1983;44:381-4 (Pubitemid 13022081)
92. Weinstein MR, Goldfield M. Lithium carbonate treatment during pregnancy (Report of a case). Dis Nerv Syst 1969;12:828-32
93. Gentile S. Neurodevelopmental effects of prenatal exposure to psychotropic medications. Depress Anxiety 2010;27:675-86
94. McKnight RF, Adida M, Budge K, et al. Lithium toxicity profile: a systematic review and meta-analysis. Lancet 2012;Early Online Publication, 20 January 2012; doi:10.1016/S0140-6736(11)61516-X.
95. Wang JF, Liu X, Christakos G, et al. Assessing local determinants of neural tube defects in the Heshun Region, Shanxi Province, China. BMC Public Health 2010;10:52-Available from: http://www. biomedcentral.com/1471-2458/10/52 [[Accessed 1 June 2010]
96. du Plessis L, Hunt RW, Fletcher AS, et al. What has happened with neural tube defects and women's understanding of folate in Victoria since 1998? Med J Aust 2008; 189: 570-4
97. Correa-Villasenor A, Ferencz C, Neill CA, et al. Ebstein's malformation of the tricuspid valve: genetic and environmental factors. Teratology 1994;50:137-47 (Pubitemid 24289115)
98. Cohen LS, Friedman JM, Jefferson JW, et al. A reevaluation of risk of in utero exposure to lithium. JAMA 1994;271:146-50 (Pubitemid 24020593)
99. Blencowe H, Cousens S, Modell B, et al. Folic acid to reduce neonatal mortality from neural tube disorders. Int J Epidemiol 2010;39(Suppl 1):i110-21
100. Valdimarsdottir U, Hultman CM, Cnattingius S, et al. Psychotic illness in first-time mothers with no previous psychiatric hospitalizations: a population-based study. PloS Med 2009;6(2):e000013-Available from: http://www.medscape.com/viewarticle/704732-print [[Accessed 29 July 2009]