Drugs in Pregnancy

New England Journal of Medicine

Volumn 338, Issue 16, 1998, Pages 1128-1137

  Koren, Gideon ^a,b,c,d   Pastuszak, Anne ^a   Ito, Shinya ^a,b,c,d  

^a HOSPITAL FOR SICK CHILDREN   (Canada)

^b HOSPITAL FOR SICK CHILDREN RESEARCH INSTITUTE   (Canada)

^c UNIVERSITY OF TORONTO   (Canada)

^d UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ALCOHOL; AMINOPTERIN; ANTIDIABETIC AGENT; ANTITHYROID AGENT; CARBAMAZEPINE; CHEMICAL TERATOGEN; CHOLINERGIC RECEPTOR BLOCKING AGENT; COCAINE; CONTRACEPTIVE AGENT; CYCLOPHOSPHAMIDE; DANAZOL; DIETHYLSTILBESTROL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ISOTRETINOIN; LEVONORGESTREL; LITHIUM; MEDROXYPROGESTERONE; METHOTREXATE; METHYLMERCURY; MISOPROSTOL; NONSTEROID ANTIINFLAMMATORY AGENT; PARAMETHADIONE; PHENYTOIN; PSYCHOTROPIC AGENT; RETINOID; TETRACYCLINE; THALIDOMIDE; TRIMETHADIONE; VALPROIC ACID; WARFARIN;

CONGENITAL MALFORMATION; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; NONHUMAN; PATIENT COUNSELING; PREGNANCY; PRENATAL EXPOSURE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TERATOGENESIS;

ABNORMALITIES, DRUG-INDUCED; ANIMALS; COUNSELING; DOXYLAMINE; DRUG COMBINATIONS; DRUG EVALUATION, PRECLINICAL; EPIDEMIOLOGIC STUDIES; FEMALE; FETUS; HUMANS; INFANT, NEWBORN; INFORMATION SERVICES; ISOTRETINOIN; PHARMACEUTICAL PREPARATIONS; PREGNANCY; PREGNANCY COMPLICATIONS; PYRIDOXINE; RISK; TERATOGENS; THALIDOMIDE;

EID: 0032537137     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199804163381607     Document Type: Review

References (95)

1. Better news on population. Lancet 1992;339:1600.
2. Koren G, Bologa M, Long D, Feldman Y, Shear NH. Perception of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester. Am J Obstet Gynecol 1989;160:1190-4.
3. Koren G, Pastuszak A. Prevention of unnecessary pregnancy termination by counselling women on drug, chemical, and radiation exposure during the first trimester. Teratology 1990;41:657-61.
4. Newton ER, ed. Medical problems in pregnancy. Med Clin North Am 1989;73:517-752.
5. Moore KL. The developing human: clinically oriented embryology. 4th ed. Philadelphia: W.B. Saunders, 1988:131.
6. Schardein JL. Chemically induced birth defects. 2nd ed. rev. New York: Marcel Dekker, 1993.
7. Lenz W, Knapp K. Die Thalidomid-Embryopathie. Dtsch Med Wochenschr 1962;87:1232-42.
8. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 4th ed. Baltimore: Williams & Wilkins, 1994.
9. Saxen I. Associations between oral clefts and drugs taken during pregnancy. Int J Epidemiol 1975;4:37-44.
10. Rosenberg L, Mitchell AA, Parsells JL, Pashayan H, Luvik C, Shapiro S. Lack of relation of oral clefts to diazepam use during pregnancy. N Engl J Med 1983,309:1282-5.
11. Shiono PH, Mills JL. Oral clefts and diazepam use during pregnancy. N Engl J Med 1984;311:919-20.
12. Czeizel A. Lack of evidence of teratogenicity of benzodiazepine drugs in Hungary. Reprod Toxicol 1987;1:183-8.
13. Nora JJ, Nora AH, Blu J, et al. Exogenous progestogen and estrogen implicated in birth defects. JAMA 1978;240:837-43.
14. Schardein JL. Congenital abnormalities and hormones during pregnancy: a clinical review. Teratology 1980;22:251-70.
15. Bracken MB. Oral contraception and congenital malformations in offspring: a review and meta-analysis of the prospective studies. Obstet Gynecol 1990;76:552-7.
16. Raman-Wilms L, Tseng AL, Wighardt S, Einarson TR, Koren G. Fetal genital effects of first-trimester sex hormone exposure: a meta-analysis. Obstet Gynecol 1995;85:141-9.
17. Jick H, Walker AM, Rothman KJ, et al. Vaginal spermicides and congenital disorders. JAMA 1981;245:1329-32.
18. Einarson TR, Koren G, Mattice D, Schechter-Tsafriri O. Maternal spermicide use and adverse reproductive outcome: a meta-analysis. Am J Obstet Gynecol 1990;162:655-60.
19. Walker BE. Induction of cleft palate in rats with antiinflammatory drugs. Teratology 1971;4:39-42.
20. Werler MM, Mitchell AA, Shapiro S. The relation of aspirin use during the first trimester of pregnancy to congenital cardiac defects. N Engl J Med 1989;321:1639-42.
21. Slone D, Siskind V, Heinonen OP, Monson RR, Kaufman DW, Shapiro S. Aspirin and congenital malformations. Lancet 1976;1:1373-5.
22. Dickson JH. Congenital deformities associated with Bendectin. Can Med Assoc J 1977;117:721.
23. Donnai D, Harris R. Unusual fetal malformations after antiemetics in pregnancy. BMJ 1978;1:691-2.
24. Einarson TR, Leeder JS, Koren G. A method for meta-analysis of epidemiological studies. Drug Intell Clin Pharm 1988;22:813-24.
25. McKeigue PM, Lamm SH, Linn S, Kutcher JS. Bendectin and birth defects. I. A meta-analysis of the epidemiologic studies. Teratology 1994; 50:27-37.
26. Neutel CI, Johansen HL. Measuring drug effectiveness by default: the case of Bendectin. Can J Public Health 1995;68:66-70.
27. Ornstein M, Einarson A, Koren G. Bendectin/Diclectin for morning sickness: a Canadian follow-up of an American tragedy. Reprod Toxicol 1995;9:1-6.
28. Mazzota P, Magee L, Koren G. Therapeutic abortions due to morning sickness: unacceptable combination. Can Fam Physician 1997;43:1055-7.
29. Fantel AG, Shepard TH, Newell-Morris LL, Moffett BC. Teratogenic effects of retinoic acid in pigtail monkeys (Macaca nemestrina). I. General features. Teratology 1977;15:65-71.
30. Lammer EJ, Chen DT, Hoar RM, et al. Retinoic acid embryopathy. N Engl J Med 1985;313:837-41.
31. A nation of illiterates. US News and World Report. May 17, 1982:1.
32. Pastuszak AL, Koren G, Rieder MJ. Use of the Retinoid Pregnancy Prevention Program in Canada: patterns of contraception use in women treated with isotretinoin and etretinate. Reprod Toxicol 1994;8:63-8.
33. Koren G. The children of neverland: the silent human disaster. Toronto: Kid In Us, 1997.
34. Jones GR. Thalidomide: 35 years on and still deforming. Lancet 1994; 343:1041.
35. Polaneczky M, Slap G, Forke C, Rappaport A, Sondheimer S. The use of levonorgestrel implants (Norplant) for contraception in adolescent mothers. N Engl J Med 1994;331:1201-6.
36. Glasier A. Emergency postcoital contraception. N Engl J Med 1997; 337:1058-64.
37. Pipkin FB, Turner SR, Symonds EM. Possible risk with captopril in pregnancy: some animal data. Lancet 1980;1:1256.
38. Rosa FW, Bosco LA, Graham CF, et al. Neonatal anuria with maternal angiotensin-converting enzyme inhibition. Obstet Gynecol 1989;74:371-4.
39. Sullivan FM, McElhatton PR. A comparison of the teratogenic activity of the antiepileptic drugs carbamazepine, clonazepam, ethosuximide, phenobarbital, phenytoin, and primidone in mice. Toxicol Appl Pharmacol 1977;40:365-78.
40. Rosa FW. Spina bifida in infants of women treated with carbamazepine during pregnancy. N Engl J Med 1991;324:674-7.
41. Wood JR Jr, Plessinger MA, Clark KE. Effect of cocaine on uterine blood flow and fetal oxygenation. JAMA 1987;257:957-61.
42. Fantel AG, Macphail BJ. The teratogenicity of cocaine. Teratology 1982;26:17-9.
43. Weathers WT, Crane MM, Sauvain KJ, Blackhurst DW. Cocaine use in women from a defined population: prevalence at delivery and effects on growth in infants. Pediatrics 1993;91:350-4.
44. Lutiger B, Graham K, Einarson TR, Koren G. Relationship between gcstational cocaine use and pregnancy outcome: a meta-analysis. Teratology 1991;44:405-14.
45. Chasnoff IJ. Cocaine, pregnancy, and the growing child. Curr Probl Pediatr 1992;22:302-21.
46. Ellis FW, Pick JR. An animal model of the fetal alcohol syndrome in beagles. Alcohol Clin Exp Res 1980;4:123-34.
47. Shoemaker WJ, Koda LY, Shoemaker CA, Bloom FE. Ethanol effects in chick embryos: cerebellar Purkinje neurons. Neurobehav Toxicol 1980; 2:239-42.
48. Sulik KK, Johnston MC, Webb MA. Fetal alcohol syndrome: embryogenesis in a mouse model. Science 1981;214:936-8.
49. Clarren SK. Recognition of fetal alcohol syndrome. JAMA 1981;245: 2436-9.
50. Streissguth AP, Aase JM, Clarren SK, Randels SP, LaDue RA, Smith DF. Fetal alcohol syndrome in adolescents and adults. JAMA 1991;265: 1961-7.
51. Wilby OK, Tesh SA, Ross FW, Tesh JM. Effects of lithium on development in vitro and in vivo in the rat. Teratology 1987;35:69. abstract.
52. Nora JJ, Nora AH, Toews WH. Lithium, Ebstein's anomaly, and other congenital heart defects. Lancet 1974;2:594-5.
53. 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.
54. Tatetsu M. Experimental manifestation of "congenital Minamata disease." Psychiatr Neurol Jpn 1968;70:162.
55. Dougherty WJ, Coulston F, Golberg L. Toxicity of methylmercury in pregnant rhesus monkeys. Toxicol Appl Pharmacol 1974;29:138. abstract.
56. Matsumoto H, Koya G, Takeuchi T. Fetal Minamata disease: a neuropathological study of two cases of intrauterine intoxication by a methyl mercury compound. J Neuropathol Exp Neurol 1965;24:563-74.
57. McClain RM, Langhoff L. Teratogenicity of diphenylhydantoin in New Zealand white rabbits. Toxicol Appl Pharmacol 1979;48:A32. abstract.
58. Finnell RH. Phenytoin-induced teratogenesis: a mouse model. Science 1981;211:483-4.
59. Harbison RD. Studies on the mechanism of teratogenic action and neonatal pharmacology of diphenylhydantoin. (Ph.D. thesis. Iowa City: State University of Iowa, 1969.)
60. Hanson JW, Smith DW. The fetal hydantoin syndrome. J Pediatr 1975; 87:285-90.
61. Scolnik D, Nulman I, Rovet J, et al. Neurodevelopment of children exposed in utero to phenytoin and carbamazepine monotherapy. JAMA 1994;271:767-70.
62. Fratta ID, Sigg EB, Maiorana K. Teratogenic effects of thalidomide in rabbits, rats, hamsters, and mice. Toxicol Appl Pharmacol 1965;7:268-86.
63. McBride WG. Thalidomide and congenital abnormalities. Lancet 1961;2:1358.
64. Nau H. Species differences in pharmacokinetics and drug teratogenesis. Environ Health Perspect 1986;70:113-29.
65. Finnel RH, Bennett GD, Karras SB, Mohl VK. Common hierarchies of susceptibility to the induction of neural tube detects in mouse embryos bv valproic acid and its 4-propyl-4-pentenoic acid metabolite. Teratology 1988;38:313-20.
66. Jager-Roman E, Deichi A, Jakob S, et al. Fetal growth, major malformations, and minor anomalies in infants born to women receiving valproic acid. J Pediatr 1986;108:997-1004.
67. Lammer EJ, Sever LE, Oakley GP Jr. Teratogen update: valproic acid. Teratology 1987;35:465-73.
68. Howe AM, Webster WS. The warfarin embryopathy: a rat model showing maxillonasal hypoplasia and other skeletal disturbances. Teratology 1992;46:379-90.
69. Hall JG, Pauli RM, Wilson KM. Maternal and fetal sequelae of anticoagulation during pregnancy. Am J Med 1980;68:122-40.
70. Baxter H, Fraser FC. The production of congenital detects in the offspring of female mice treated with cortisone. McGill Med J 1950;19:245-9.
71. Fainstat T. Cortisone-induced congenital cleft palate in rabbits. Endocrinology 1954;55:502-8.
72. Buresh JJ, Urban TJ. The teratogenic effect of the steroid nucleus in the rat. J Dent Res 1970;43:548-54.
73. Wilson JG, Fradkin R, Schumacher HJ. Influence of drug pretreatment on the effectiveness of known teratogenic agents. Teratology 1970; 3:210-1. abstract.
74. Pinsky L, DiGeorge AM. Cleft palate in the mouse: a teratogenic index of glucocorticoid potency. Science 1965;147:402-3.
75. Fraser FC, Sajoo A. Teratogenic potential of corticosteroids in humans. Teratology 1995,51:45-6.
76. Shepard TH. Catalog of teratogenic agents. 7th ed. Baltimore: Johns Hopkins University Press, 1994.
77. Miller RP, Becker BA. Teratogenicity of oral diazepam and diphenylhydantoin in mice. Toxicol Appl Pharmacol 1975;32:53-61.
78. Klein KL, Scott WJ, Wilson JG. Aspirin-induced teratogenesis: a unique pattern of cell death and subsequent polydactyly in the rat. J Exp Zool 1981;216:107-12.
79. Wilson JG, Ritter EJ, Scott WJ, Fradkin R. Comparative distribution and embryotoxicity of acetylsalicylic acid in pregnant rats and rhesus monkeys. Toxicol Appl Pharmacol 1977;41:67-78.
80. Beall JR, Klein MF. Enhancement of aspirin-induced teratogenicity by food restriction in rats. Toxicol Appl Pharmacol 1977;39:489-95.
81. Mastroiacovo P, Corchia C, Botto LD, Lanni R, Zampino G, Fusco D. Epidemiology and genetics of microtia-anotia: a registry based study on over one million births. J Med Genet 1995;52:453-7.
82. Herbst AL, Scully RE. Adenocarcinoma of the vagina in adolescence: a report of 7 cases including 6 clear-cell carcinomas. Cancer 1970;25:745-57.
83. Rosa FW. Teratogenicity of isotretinoin. Lancet 1983;2:513.
84. Koren G, Pastuszak A. Teratogen information services. In: Koren G, ed. Maternal-fetal toxicology: a clinician's guide. 2nd ed. rev. New York: Marcel Dekker, 1994:683-705.
85. Pastuszak A, Schick-Boschetto B, Zuber C, et al. Pregnancy outcome following first-trimester exposure to fluoxetine. JAMA 1993;269:2246-8.
86. Goldstein DJ, Corbin LA, Sundell KL. Effects of first-trimester fluoxetine exposure on the newborn. Obstet Gynecol 1997;89:713-8.
87. Adams J. Neural and behavioral pathology following prenatal exposure to retinoids. In: Koren G, ed. Retinoids in clinical practice: the risk-benefit ratio. New York: Marcel Dekker, 1993:111-28.
88. Gonen R, Shilalukey K, Magee L, Koren G, Shime J. Maternal disorders leading to increased reproductive risk. In: Koren G, ed. Maternal-fetal toxicology: a clinician's guide. 2nd ed. rev. New York: Marcel Dekker, 1994:641-82.
89. Feldman Y, Koren G, Mattice K, Shear H, Pellegrini E, MacLeod SM. Determinants of recall and recall bias in studying drug and chemical exposure in pregnancy. Teratology 1989;40:37-45.
90. Werler MM, Shapiro S, Mitchell AA. Periconceptional folic acid exposure and risk of occurrent neural tube defects. JAMA 1993;269:1257-61.
91. McCall RB. The development of intellectual functioning in infancy and the prediction of later I.Q. In: Osofsky JD, ed. Handbook of infant development. New York: John Wiley, 1979:707-41.
92. Teratology Society Public Affairs Committee. FDA classification or drugs for teratogenic risk. Teratology 1994;49:446-7.
93. Smith J, Taddio A, Koren G. Drugs of choice for pregnant women. In: Koren G, ed. Maternal-fetal toxicology: a clinician's guide. 2nd ed. rev. New York: Marcel Dekker, 1994:115-28.
94. Loebstein R, Lalkin A, Koren G. Pregnancy induced pharmacokinetic changes and their clinical relevance. Clin Pharmacokinet 1997;33:328-43.
95. Theis JGW. Acetylsalicylic acid (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy: are they safe? Can Fam Physician 1996;42:2347-9.