Evaluating the postmarketing experience of risperidone use during pregnancy: Pregnancy and neonatal outcomes

Drug Safety

Volumn 30, Issue 3, 2007, Pages 247-264

  Coppola, Danielle ^a   Russo, Leo J ^a   Kwarta Jr , Robert F ^a   Varughese, Ruana ^a   Schmider, Juergen ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BUPRENORPHINE; CARBAMAZEPINE; CHLORPROMAZINE; CLOMIPRAMINE; CLONAZEPAM; CLORAZEPATE DIPOTASSIUM; CLOXAZOLAM; CLOZAPINE; CYAMEMAZINE; DIAZEPAM; FLUNITRAZEPAM; HALOPERIDOL; IMIPRAMINE; LEVOMEPROMAZINE; LORMETAZEPAM; METHADONE; NITRAZEPAM; PAROXETINE; PENTAZOCINE; PETHIDINE; PHENOBARBITAL; PRAZEPAM; PROMETHAZINE; RISPERIDONE; SERTRALINE; SULPIRIDE; TROPATEPINE; UNINDEXED DRUG; VALPROIC ACID; ZUCLOPENTHIXOL;

ADULT; AGITATION; AIRWAY OBSTRUCTION; ARTICLE; BEHAVIOR DISORDER; BIRTH INJURY; BRAIN MALFORMATION; CONGENITAL HEART MALFORMATION; CONGENITAL MALFORMATION; CONTROLLED STUDY; CONVULSION; CYANOSIS; DEVELOPMENTAL COORDINATION DISORDER; DIARRHEA; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG USE; DYSKINESIA; DYSTONIA; EATING DISORDER; ERYTHRODERMA; EXTERNAL EAR MALFORMATION; EXTRAPYRAMIDAL SYNDROME; FEMALE; HUMAN; HYPERREFLEXIA; HYPERSALIVATION; HYPERSENSITIVITY; INDUCED ABORTION; INTESTINE MALFORMATION; INVOLUNTARY MOVEMENT; IRRITABILITY; JAUNDICE; LARYNGOMALACIA; LETHARGY; LIP MALFORMATION; MOTOR DYSFUNCTION; MUSCLE CONTRACTION; MUSCLE HYPERTONIA; MUSCLE SPASM; MUSCLE TONE; MYELINATION; NERVOUSNESS; NEWBORN; NEWBORN CARE; NYSTAGMUS; OLIGOHYDRAMNIOS; PALATE MALFORMATION; PALLOR; POSTMARKETING SURVEILLANCE; PREGNANCY OUTCOME; PREMATURITY; PRENATAL EXPOSURE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SCHIZOPHRENIA; SEIZURE; SIDE EFFECT; SKELETON MALFORMATION; SOMNOLENCE; SPONTANEOUS ABORTION; STILLBIRTH; TACHYPNEA; TERATOGENICITY; TREMOR; UNSPECIFIED SIDE EFFECT; WITHDRAWAL SYNDROME;

EID: 33947269105     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200730030-00006     Document Type: Article

References (47)

1. Leung A, Chue P. Sex differences in schizophrenia, a review of the literature. Acta Psychiatr Scand Suppl. 2000; 401: 3-38
2. Howard LM, Kumar C, Leese M, et al. The general fertility rate in women with psychotic disorders. Am J Psychiatry 2002; 159: 991-7
3. Calabrese JR, Gulledge AD. Psychotropics during pregnancy and lactation: a review. Psychosomatics 1985 May; 26 (5): 413-6
4. Mortola JF. The use of psychotropic agents in pregnancy and lactation. Psychiatr Clin North Am 1989 Mar; 12 (1): 69-87
5. Miller LJ. Clinical strategies for the use of psychotropic drugs during pregnancy. Psychiatr Med 1991; 9 (2): 275-98
6. Cohen LS. Psychotropic drug use in pregnancy. Hosp Community Psychiatry 1989 Jun; 40 (6): 566-7
7. Thiels C, Steinhausen HC. Pharmacotherapy of psychiatric disorder in pregnancy and during breastfeeding: a review. Pharmacopsychiatry 1987 Jul; 20 (4): 133-46
8. Goldberg HL. Psychotropic drugs in pregnancy and lactation. Int J Psychiatry Med 1994; 24 (2): 129-47
9. Rumeau-Rouquette C, Goujard J, Huel G. Possible teratogenic effect of phenothiazines in human beings. Teratology 1977 Feb; 15 (1): 57-64
10. Slone D, Siskind V, Heinonen OP, et al. Antenatal exposure to the phenothiazines in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score. Am J Obstet Gynecol 1977 Jul; 128 (5): 486-8
11. Schou M, Goldfield MD, Weinstein MR, et al. Lithium and pregnancy: report from the Register of Lithium Babies. BMJ 1973 Apr; 2 (5859): 135-6
12. Kallen B, Tandberg A. Lithium and pregnancy: a cohort study on manic-depressive women. Acta Psychiatr Scand 1983 Aug; 68 (2): 134-9
13. Cohen LS, Friedman JM, Jefferson JW, et al. A reevaluation of risk of in utero exposure to lithium. JAMA 1994 Jan; 271 (2): 146-50
14. Shaw GM, Wasserman CR, O'Malley CD, et al. Orofacial clefts and maternal anticonvulsant use. Reprod Toxicol 1995 Jan-Feb; 9 (1): 97-8
15. Laegreid L, Olegard R, Conradi N, et al. Congenital malformations and maternal consumption of benzodiazepines: a case-control study. Dev Med Child Neurol 1990 May; 32 (5): 432-41
16. McKenna K, Koren G, Tetelbaum M, et al. Pregnancy outcome of women using atypical antipsychotic drugs: a prospective comparative study. J Clin Psychiatry 2005 Apr; 66 (4): 444-9
17. Fleischhacker W, Eerdekens M, Karcher K, et al. Treatment of schizophrenia with long-acting injectable risperidone: a 12 month evaluation of the first long-acting 2nd generation antipsychotic. J Clin Psychiatry 2003 Oct; 64: 1250-7
18. Kane JM, Eerdekens M, Lindenmayer JP, et al. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotics. Am J Psychiatry Jun 2003; 160 (6): 1125-32
19. Chue P, Eerdekens M, Augustyns I, et al. Comparative efficacy and safety of long-acting risperidone and risperidone oral tablets. Eur Neuropsychopharmacol 2005 Jan; 15 (1): 111-7
20. Hirschfeld RM, Keck PE Jr, Kramer M, et al. Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial. Am J Psychiatry 2004 Jun; 161 (6): 1057-65
21. Segal J, Berk M, Brook S. Risperidone compared with both lithium and haloperidol in mania: a double-blind randomized controlled trial. Clin Neuropharmacol 1998 May-Jun; 21 (3): 176-180
22. Sachs GS, Grossman F, Ghaemi SN, et al. Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: a double-blind, placebo-controlled comparison of efficacy and safety. Am J Psychiatry 2002 Jul; 159 (7): 1146-54
23. Data on file, Johnson & Johnson, 2006
24. Risperdal (risperidone). Janssen, LP prescribing information [online]. Available from URL: http://www.risperdal.com [Accessed 2005 Dec 1]
25. Reilly T, Heylen SLE. Guidelines for the practical use of risperidone. In: Kane JM, Moller HJ, Awouters F, editors. Serotonin in antipsychotic treatment. New York (NY): Dekker Inc, 1996: 357-68
26. Medical Economics staff, editors. Physicians' Desk Reference. 57th ed. Montvale (NJ): Thomson PDR, 2003
27. March of Dimes [online]. Available from URL: http://www.marchofdimes.com [Accessed 2006 Jan 3]
28. American College of Obstetics and Gynecology [online]. Available from URL: http://www.americanpregnancy.org. [Accessed 2005 Dec 1]
29. Howard LM, Kumar R, Thornicroft G. Psychosocial characteristics and needs of mothers with psychotic disorders. Br J Psychiatry 2001 May; 178: 427-32
30. Allison SK. Psychotropic medication in pregnancy: ethical aspects and clinical management. J Perinat Neonatal Nurs 2004 Jul-Sept; 18 (3): 194-205
31. Casiano ME, Hawkins DR. Major mental illness and childbearing: a role for the consultation-liaison psychiatrist in obstetrics. Psychiatr Clin North Am 1987 Mar; 10 (1): 35-51
32. Bagnall AM, Jones L, Ginnelly L, et al. A systematic review of atypical antipsychotic drugs in schizophrenia. Health Technol Assess 2003; 7 (13): 1-193
33. Moller HJ. Neuroleptic treatment of negative symptoms in schizophrenic patients: efficacy problems and methodological difficulties. Eur Neuropsychopharmacol 1993 March; 3 (1): 1-11
34. Stanniland C, Taylor D. Tolerability of atypical antipsychotics. Drug Safety 2000 Mar; 22 (3): 195-214
35. Wolfgang P, Schloemp S, Sterzik K, et al. Atypical antipstychotic agents in early pregnancy. Reprod Toxicol 2005; 20: 453-91
36. Maciag D, Simpson KL, Coppinger D, et al. Neonatal antidepressant exposure has lasting effects on behavior and serotonin circuitry. Neuropsychopharmacology 2006 Jan; 31 (1): 47-57
37. Costei AM, Kozer E, Ho T, et al. Perinatal outcome following third trimester exposure to paroxetine. Arch Pediatr Adolesc Med 2002 Nov; 156 (11): 1129-32
38. Lin AE, Peller AJ, Westgate MN, et al. Clonazepam use in pregnancy and the risk of malformations. Birth Defects Res Clin Mol Teratol 2004 Dec; 70 (8): 534-6
39. Iqbal MM, Sobhan T, Ryals T. Effects of commonly used benzodiazepines on the fetus, the neonate, and the nursing infant. Psychiatr Serv 2002 Jan; 53 (1): 39-49
40. Pennell PB. Using current evidence in selecting antiepileptic drugs for use during pregnancy. Epilepsy Curr 2005 Mar-Apr; 5 (2): 45-51
41. Bennedsen BE. Adverse pregnancy outcome in schizophrenic women: occurrence and risk factors. Schizophr Res 1998 Sept; 33 (1-2): 1-26
42. Kallen K. Maternal smoking and urinary organ malformations. Int J Epidemiol 1997 Jun; 26 (3): 571-4
43. Meyer KA, Williams P, Hernandez-Diaz S, et al. Smoking and the risk of oral clefts: exploring the impact of study designs. Epidemiology 2004 Nov; 15 (6): 671-8
44. Regier DA, Farmer ME, Rae DS, et al. Comorbidity of mental disorders with alcohol and other drug abuse: results from the Epidemiologic Catchment Area (ECA) Study. JAMA 1990 Nov; 264 (19): 2511-8
45. Singer HS. Tardive dyskinesia: a concern for the pediatrician. Pediatrics 1986 Apr; 77 (4): 553-6
46. Gualtieri CT, Quade D, Hicks RE, et al. Tardive dyskinesia and other clinical consequences of neuroleptic treatment in children and adolescents. Am J Psychiatry 1984 Jan; 141 (1): 20-3
47. Sexson WR, Barak Y. Withdrawal emergent syndrome in an infant associated with maternal haloperidol therapy. J Perinatol 1989 Jun; 9 (2): 170-2