Pregnancy registries in epilepsy: A consensus statement on health outcomes

Neurology

Volumn 71, Issue 14, 2008, Pages 1109-1117

  Meador, K J ^a,b   Pennell, P B ^b   Harden, C L ^c   Gordon, J C ^d   Tomson, T ^e   Kaplan, P W ^f   Holmes, G L ^g   French, J A ^h   Hauser, W A ⁱ   Wells, P G ^j   Cramer, J A ^k  

^a UNIVERSITY OF FLORIDA   (United States)

^b EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

^d Epilepsy Therapy Project   (United States)

^e KAROLINSKA INSTITUTE   (Sweden)

^f JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g DARTMOUTH MEDICAL SCHOOL   (United States)

^h NEW YORK UNIVERSITY   (United States)

ⁱ University of Toronto ^*  (United States)

^j UNIVERSITY OF TORONTO   (Canada)

^k YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; CLONAZEPAM; DIAZEPAM; ETIRACETAM; LAMOTRIGINE; PHENOBARBITAL; PHENYTOIN; TOPIRAMATE; VALPROIC ACID; VIGABATRIN;

ADVERSE OUTCOME; BEHAVIOR; CLEFT LIP; CLEFT PALATE; CLINICAL TRIAL; COGNITION; CONGENITAL MALFORMATION; CONSENSUS; EPILEPSY; ETHICS; FETUS DEATH; FETUS DEVELOPMENT; FOLLOW UP; HUMAN; KNOWLEDGE; MEDICAL RESEARCH; NONHUMAN; ORGANIZATION; OUTCOME ASSESSMENT; PREGNANCY; PRIORITY JOURNAL; REGISTER; REGULATORY MECHANISM; REPRODUCTION; REVIEW; RISK; SIDE EFFECT; TERATOGENICITY; AUSTRALIA; CHEMICALLY INDUCED DISORDER; COGNITIVE DEFECT; CONFERENCE PAPER; CONSENSUS DEVELOPMENT; DEVELOPMENTAL DISORDER; EUROPE; FEMALE; MENTAL DEFICIENCY; MULTICENTER STUDY; POSTMARKETING SURVEILLANCE; PREGNANCY COMPLICATION; PRESCHOOL CHILD; STATISTICS; UNITED KINGDOM; UNITED STATES;

ABNORMALITIES, DRUG-INDUCED; ANTICONVULSANTS; AUSTRALIA; CHILD, PRESCHOOL; COGNITION DISORDERS; DEVELOPMENTAL DISABILITIES; EPILEPSY; EUROPE; FEMALE; GREAT BRITAIN; HUMANS; MENTAL RETARDATION; MULTICENTER STUDIES AS TOPIC; OUTCOME ASSESSMENT (HEALTH CARE); PREGNANCY; PREGNANCY COMPLICATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; REGISTRIES; UNITED STATES;

EID: 54549119442     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/01.wnl.0000316199.92256.af     Document Type: Review

References (60)

1. Artama M, Isojarvi JIT, Raitanen T, Auvinen A. Birth rate among patients with epilepsy: a nationwide populationbased cohort study in Finland. Am J Epidemiol 2004;159: 1057-1063.
2. Schupf N, Ottman R. Reproduction among individuals with idiopathic/cryptogenic epilepsy: risk factors for reduced fertility in marriage. Epilepsia 1996;37:833-840.
3. Agarwal P, Mehndiratta MM, Antony AR, et al. Epilepsy in India: nuptiality behaviour and fertility. Seizure 2006; 15:409-415.
4. Dansky LV, Andermann E, Andermann F. Marriage and fertility in epileptic patients. Epilepsia 1980;21:261-271.
5. Schupf N, Ottman R. Reproduction among individuals with idiopathic/cryptogenic epilepsy: risk factors for spontaneous abortion. Epilepsia 1997;38:824-829.
6. Holmes LB, Harvey EA, Coull BA, et al. The teratogenicity of anticonvulsant drugs. N Engl J Med 2001;344: 1132-1138.
7. Olafsson E, Hallgrimsson JT, Hauser WA, Ludvigsson P, Gudmundsson G. Pregnancies of women with epilepsy: a population-based study in Iceland. Epilepsia 1998;39: 887-892.
8. Minkoff H, Schaffer RM, Delke I, Grunebaum AN. Diagnosis of intracranial hemorrhage in utero after a maternal seizure. Obstet Gynecol 1985;65:22S-24S.
9. Hiilesmaa VK, Bardy A, Teramo K. Obstetric outcome in women with epilepsy. Am J Obstet Gynecol 1985;152: 499-504.
10. Sahoo S, Klein P. Maternal complex partial seizure associated with fetal distress. Arch Neurol 2005;62:1304-1305.
11. Nei M, Daly S, Liporace J. A maternal complex partial seizure in labor can affect fetal heart rate. Neurology 1998; 51:904-1006.
12. Crawford P. Management of epilepsy in pregnancy. Rev Future Neurol 2006;1:303-310.
13. Teramo K, Hiilesmaa V, Brady A, Saarikosk S. Fetal heart rate during a grand mal epileptic seizure. J Perinat Med 1979;7:3-6.
14. EURAP Study Group. Seizure control and treatment in pregnancy: observations from the EURAP epilepsy pregnancy registry. Neurology 2006;66:354-360.
15. Friis ML. Facial clefts and congenital heart defects in children of parents with epilepsy: genetic and environmental etiologic factors. Acta Neurol Scand 1989;79:433-459.
16. Kaneko S, Otani K, Fukushima Y, et al. Teratogenicity of antiepileptic drugs: analysis of possible risk factors. Epilepsia 1988;29:459-467.
17. Pschirrer ER, Monga M. Seizure disorders in pregnancy. Obstet Gynecol Clin North Am 2001;28:601.
18. Yerby M, Koepsell T, Daling J. Pregnancy complications and outcomes in a cohort of women with epilepsy. Epilepsia 1985;26:631-635.
19. Hamilton BE, Martin JA, Ventura SJ, Sutton PD, Menacker F. Births: preliminary data for 2004. Natl Vital Stat Rep 2005;54:1-17.
20. Wide K, Winbladh B, Kallen B. Major malformations in infants exposed to antiepileptic drugs in utero, with emphasis on carbamazepine and valproic acid: a nation-wide, population-based register study. Acta Paediatr 2004;93: 174-176.
21. Artama M, Auvinen A, Raudaskoski T, Isojarvi I, Isojarvi J. Antiepileptic drug use of women with epilepsy and congenital malformations in offspring. Neurology 2005;64: 1874-1878.
22. Guidance for Industry: Establishing Pregnancy Exposure Registries. US department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. 2002 Aug. Available at: http://www.fda.gov/cber/gdlns/pregexp.htm.
23. Tomson T, Battino D. Teratogenicity of antiepileptic drugs: state of the art: review. Curr Opin Neurol 2005;18: 135-140.
24. Holmes LB, Wyszynski DF, Lieberman ES. The AED (antiepileptic drug) Pregnancy Registry: a 6-year experience. Arch Neurol 2004;61:673-678.
25. Wyszynski DF, Nambisan M, Surve T, et al. Increased rate of major malformations in offspring exposed to valproate during pregnancy. Neurology 2005;64:961-965.
26. Holmes LB, Wyszynski DF, Baldwin EJ, et al. Increased risk for non-syndromic cleft palate among infants exposed to lamotrigine during pregnancy. Birth Def Res (Part A): Clin Mol Teratol 2006;76:318.
27. Hernandez-Diaz S, Smith CR, Wyszynski DP, Holmes LB. Malformations among infants exposed to carbamazepine during pregnancy. Birth Def Res (Part A): Clin Mol Teratol 2007;79:357.
28. Morrow JI, Russell A, Gutherie E, et al. Malformation risks of anti-epileptic drugs in pregnancy: a prospective study from the UK Epilepsy and Pregnancy Register. J Neurol Neurosurg Psychiatry 2006;77:193-198.
29. Hunt S, Craig J, Russell A, et al. Levetiracetam in pregnancy: preliminary experience from the UK Epilepsy and Pregnancy Register. Neurology 2006;67:1876-1879.
30. Vajda FJE, Hitchcock A, Graham J, O'Brien T, Lander C, Eadie M. The Australian Register of antiepileptic drugs in pregnancy: the first 1002 pregnancies. Aust NZ J Obstet Gynaecol 2007;47:468-474.
31. Meador KJ, Browning N, Cohen MJ, et al. In utero antiepileptic drugs: differential cognitive outcomes in children of women with epilepsy. AES Abstract 2006. Available at: http://www.aesnet.org/Visitors/AnnualMeeting/Abstractsnew/ dsp-Abstract.cfm?id=5.
32. Cunnington M, Tennis P, International Lamotrigine Pregnancy Registry Scientific Advisory Committee. Lamotrigine and the risk of malformations in pregnancy. Neurology 2005;64:955-960.
33. Cunnington M, Ferber S, Quartey G, International Lamotrigine Pregnancy Registry Scientific Advisory Committee. Effect of dose on the frequency of major birth defects following fetal exposure to lamotrigine monotherapy in an international observational study. Epilepsia 2007; 48:1207-1210.
34. Fisher JE, Vorhees C. Developmental toxicity of antiepileptic drugs: relationship to postnatal dysfunction. Pharmacol Res 1992;26:207-221.
35. Wide K, Hening E, Tomson T, Winbladh B. Psychomotor development in preschool children exposed to antiepileptic drugs in utero. Acta Paediatr 2002;91:409-414.
36. Gaily E, Kantola-Sorsa E, Hiilesmaa V, et al. Normal intelligence in children with prenatal exposure to carbamazepine. Neurology 2004;62:28-32.
37. Rasalam AD, Hailey H, Williams LHG, et al. Characteristics of fetal anticonvulsant syndrome associated autistic disorder. Dev Med Child Neurol 2005;47:551-555.
38. Shapiro S, Hartz SC, Siskind V, et al. Anticonvulsants and parental epilepsy in the development of birth defects. Lancet 1976;1:272-275.
39. Sulzbacher S, Farwell JR, Temkin N, Lu AS, Hirtz DG. Late cognitive effects of early treatment with Phenobarbital. Clin Pediatr (Phila) 1999;38:387-394.
40. Gaily E, Kantola-Sorsa E, Granstrom ML. Intelligence of children of epileptic mothers. J Pediatr 1988;113:677-684.
41. Hanson JW, Myrianthopoulos NC, Harvey MA, Smith DW. Risks to the offspring of women treated with hydantoin anticonvulsants, with emphasis on the fetal hydantoin syndrome. J Pediatr 1976;89:662-668.
42. Eriksson K, Viinikainen K, Mönkkönen A, et al. Children exposed to valproate in utero: population based evaluation of risks and confounding factors for long-term neurocognitive development. Epilepsy Res 2005;65:189-200.
43. Adab N, Kini U, Vinten J, et al. The longer term outcome of children born to mothers with epilepsy. J Neurol Neurosurg Psychiatry 2004;75:1575-1583.
44. Adab N, Jacoby A, Smith D, Chadwick D. Additional educational needs in children born to mothers with epilepsy. J Neurol Neurosurg Psychiatry 2001;70:15-21.
45. Dean J, Hailey H, Moore S, et al. Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. J Med Genet 2002;39:252-259.
46. Finnell RH, Chernoff GF. Gene-teratogen interactions. An approach to understanding the metabolic basis of birth defects. In: Nau H, Scott WJ, eds. Pharmacokinetics in Teratogenesis. Boca Raton, FL: CRC Press; 1987:97-109.
47. Meador KJ. Cognitive effects of epilepsy and of antiepileptic medications. In: Wyllie E, ed. The Treatment of Epilepsy. Principles and Practices, 4th Edition. Philadelphia: Lippincott Williams & Wilkins; 2005:1185-1195.
48. Wells PG, Kim PM, Laposa RR, et al. Oxidative damage in chemical teratogenesis. Mutat Res 1997;396:65-78.
49. Bittigau P, Sifringer M, Ikonomidou C. Antiepileptic drugs and apoptosis in the developing brain. Ann NY Acad Sci 2003;993:103-114.
50. Glier C, Dzietko M, Bittigau P, et al. Therapeutic doses of topiramate are not toxic to the developing rat brain. Exp Neurol 2004;187:403-409.
51. Katz I, Kim J, Gale KN, Kondratyev AD. Effects of lamotrigine alone and in combination with MK-801, phenobarbital, or phenytoin on cell death in the neonatal rat brain. J Pharmacol Exp Ther. Available at: http://jpet. aspetjournals.org/cgi/reprint/jpet.107.123133v1.
52. Kim J, Kondratyev A, Gale K. Enhancement of phenytoininduced neuronal death in neonatal rats by AEDs that do not induce neuronal death when given alone. AES Annual Meeting Abstract. 2006. Available at: http://www.aesnet.org/ Visitors/AnnualMeeting/Abstractsnew/dsp-Abstract.cfm?id=562.
53. Manthey D, Asimiadou S, Stefovska V, et al. Sulthiame but not levetiracetam exerts neurotoxic effect in the developing rat brain. Exp Neurol 2005;193:497-503.
54. Manent JB, Jorquera I, Mazzucchelli I, et al. Fetal exposure to GABA-acting antiepileptic drugs generates hippocampal and cortical dysplasias. Epilepsia 2007;48:684-693.
55. Pennell PB. Antiepileptic drug pharmacokinetics during pregnancy and lactation. Neurology 2003;61(6 suppl 2): S35-S42.
56. Tomson T. Gender aspects of pharmacokinetics of new and old antiepileptic drugs: pregnancy and breast-feeding. Ther Drug Monit 2005;27:718-721.
57. Pennell PB, Newport DJ, Stowe ZN, Helmers SL, Montgomery JQ, Henry TR. The impact of pregnancy and childbirth on the metabolism of lamotrigine. Neurology 2004;62: 292-295.
58. Christensen J, Sabers A, Sidenius P. Oxcarbazepine concentrations during pregnancy: a retrospective study in patients with epilepsy. Neurology 2006;67:1497-1499.
59. Tomson T, Palm R, Källén K, et al. Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation. Epilepsia 2007;48:1111-1116.
60. Practice parameter: management issues for women with epilepsy (summary statement). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 1998;51:944-948.