메뉴 건너뛰기




Volumn , Issue , 2007, Pages 501-514

Studies of Drug-Induced Birth Defects

Author keywords

"class action" teratogenesis fallacy; Biologic plausibility in drug defect associations; Case control surveillance and drug induced birth defects; Drug induced birth defect; Maternal rubella infection in pregnancy; Non prescription (or over the counter, OTC) drugs; specific birth defect and sample size requirement; System for Thalidomide Education and Prescribing Safety (STEPS); Teratogenesis adverse drug effect

Indexed keywords


EID: 84889294771     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470059876.ch32     Document Type: Chapter
Times cited : (15)

References (66)
  • 1
    • 0004077988 scopus 로고
    • The women, their offspring, and the malformations. In: Kaufman DW, ed.
    • Littleton, MA: Publishing Sciences Group
    • Heinonen OP, Slone D, Shapiro S. The women, their offspring, and the malformations. In: Kaufman DW, ed., Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977; pp. 30-32.
    • (1977) Birth Defects and Drugs in Pregnancy , pp. 30-32
    • Heinonen, O.P.1    Slone, D.2    Shapiro, S.3
  • 2
    • 0039190478 scopus 로고
    • Congenital Malformations Surveillance Report: January 1982-December 1985
    • CDC, Atlanta, GA: US Department of Health and Human Services, Public Health Service
    • CDC. Congenital Malformations Surveillance Report: January 1982-December 1985. Atlanta, GA: US Department of Health and Human Services, Public Health Service, 1988.
    • (1988)
  • 3
    • 0001846970 scopus 로고
    • Congenital cataract following German measles in the mother
    • Gregg NM. Congenital cataract following German measles in the mother. Trans Ophthalmol Soc Aust 1941; 3: 35-46.
    • (1941) Trans Ophthalmol Soc Aust , vol.3 , pp. 35-46
    • Gregg, N.M.1
  • 4
    • 49749219257 scopus 로고
    • Thalidomide and congenital abnormalities
    • Lenz W. Thalidomide and congenital abnormalities. Lancet 1962; 1: 45.
    • (1962) Lancet , vol.1 , pp. 45
    • Lenz, W.1
  • 5
    • 0016066904 scopus 로고
    • Problems in applying teratologic observations in animals to man
    • Warkany J. Problems in applying teratologic observations in animals to man. Pediatrics 1974; 53: 820.
    • (1974) Pediatrics , vol.53 , pp. 820
    • Warkany, J.1
  • 6
    • 0346256841 scopus 로고    scopus 로고
    • Systematic identification of drugs that cause birth defects-a new opportunity
    • Mitchell AA. Systematic identification of drugs that cause birth defects-a new opportunity. N Engl J Med 2003; 349: 2556-9.
    • (2003) N Engl J Med , vol.349 , pp. 2556-2559
    • Mitchell, A.A.1
  • 7
    • 0024516104 scopus 로고
    • When a uniquely effective drug is teratogenic: the case of isotreninoin
    • Stern RS. When a uniquely effective drug is teratogenic: the case of isotreninoin. N Engl J Med 1989; 320: 1007-9.
    • (1989) N Engl J Med , vol.320 , pp. 1007-1009
    • Stern, R.S.1
  • 8
    • 0029021685 scopus 로고
    • A pregnancyprevention program in women of childbearing age receiving isotretinoin
    • Mitchell AA, Van Bennekom C, Louik C. A pregnancyprevention program in women of childbearing age receiving isotretinoin. N Engl J Med 1995; 333: 101-6.
    • (1995) N Engl J Med , vol.333 , pp. 101-106
    • Mitchell, A.A.1    Van Bennekom, C.2    Louik, C.3
  • 9
    • 84889458815 scopus 로고    scopus 로고
    • Isotretinoin Survey
    • Presentation at FDA Advisory Committees. Gaithersburg, MD, February 26
    • Mitchell AA, Van Bennekom C. Isotretinoin Survey. Presentation at FDA Advisory Committees. Gaithersburg, MD, February 26, 2004.
    • (2004)
    • Mitchell, A.A.1    Van Bennekom, C.2
  • 10
    • 0020959379 scopus 로고
    • Teratogen update: Bendectin
    • Holmes LB. Teratogen update: Bendectin. Teratology 1983; 27: 277-81.
    • (1983) Teratology , vol.27 , pp. 277-281
    • Holmes, L.B.1
  • 11
    • 0028914991 scopus 로고
    • Measuring drug effectiveness by default: the case of Bendectin
    • Neutel CI, Johansen HL. Measuring drug effectiveness by default: the case of Bendectin. Can J Pub Health 1995; 86:66-70.
    • (1995) Can J Pub Health , vol.86 , pp. 66-70
    • Neutel, C.I.1    Johansen, H.L.2
  • 12
    • 0017287441 scopus 로고
    • Consequences of a nationwide ban on spray adhesives alleged to be human teratogens and mutagens
    • Hook EB, Healy KB. Consequences of a nationwide ban on spray adhesives alleged to be human teratogens and mutagens. Science 1976; 191: 566-7.
    • (1976) Science , vol.191 , pp. 566-567
    • Hook, E.B.1    Healy, K.B.2
  • 13
    • 0002491348 scopus 로고
    • Sedatives, tranquilizers, and antidepressant drugs
    • Littleton, MA: Publishing Sciences Group
    • Heinonen OP, Slone D, Shapiro S. Sedatives, tranquilizers, and antidepressant drugs. In: Kaufman DW, ed., Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977; pp. 335-44.
    • (1977) Birth Defects and Drugs in Pregnancy , pp. 335-344
    • Heinonen, O.P.1    Slone, D.2    Shapiro, S.3
  • 14
    • 0021848841 scopus 로고
    • Teratogen update: clinical aspects of thalidomide embryopathy-a continuing preoccupation
    • Newman CGH. Teratogen update: clinical aspects of thalidomide embryopathy-a continuing preoccupation. Teratology 1985; 32: 133-44.
    • (1985) Teratology , vol.32 , pp. 133-144
    • Newman, C.G.H.1
  • 16
    • 0029959905 scopus 로고    scopus 로고
    • Robert E. [Example of teratogen detection using a birth defects registry: depakine and spina bifida.]
    • suppl 1, in French
    • Robert E. [Example of teratogen detection using a birth defects registry: depakine and spina bifida.] Rev Epidemiol Sante Publique 1996; 44 (suppl 1): 78-81 (in French).
    • (1996) Rev Epidemiol Sante Publique , vol.44 , pp. 78-81
  • 17
    • 0018905381 scopus 로고
    • Chondrodysplasia punctata after warfarin in early pregnancy
    • Whitfield MF. Chondrodysplasia punctata after warfarin in early pregnancy. Arch Dis Child 1980; 55: 139-42.
    • (1980) Arch Dis Child , vol.55 , pp. 139-142
    • Whitfield, M.F.1
  • 18
    • 0026775429 scopus 로고
    • Effect of ACE inhibition on the fetal kidney: decreased renal blood flow
    • Martin RA, Jones KL, Mendoza A, Barr M, Benirschke K. Effect of ACE inhibition on the fetal kidney: decreased renal blood flow. Teratology 1992; 46: 317-21.
    • (1992) Teratology , vol.46 , pp. 317-321
    • Martin, R.A.1    Jones, K.L.2    Mendoza, A.3    Barr, M.4    Benirschke, K.5
  • 19
    • 0026566545 scopus 로고
    • First trimester maternal medication use in relation to gastroschisis
    • Werler MM, Mitchell AA, Shapiro S. First trimester maternal medication use in relation to gastroschisis. Teratology 1992; 45: 361-7.
    • (1992) Teratology , vol.45 , pp. 361-367
    • Werler, M.M.1    Mitchell, A.A.2    Shapiro, S.3
  • 20
    • 0020416265 scopus 로고
    • Changing trends in drug use during pregnancy
    • Rayburn W, Wible-Kant J, Bledsoe P. Changing trends in drug use during pregnancy. J Reprod Med 1982; 27: 569-75.
    • (1982) J Reprod Med , vol.27 , pp. 569-575
    • Rayburn, W.1    Wible-Kant, J.2    Bledsoe, P.3
  • 23
    • 0022632256 scopus 로고
    • Effect of questionnaire design on recall of drug exposure in pregnancy
    • Mitchell AA, Cottler LB, Shapiro S. Effect of questionnaire design on recall of drug exposure in pregnancy. Am J Epidemiol 1986; 123: 670-6.
    • (1986) Am J Epidemiol , vol.123 , pp. 670-676
    • Mitchell, A.A.1    Cottler, L.B.2    Shapiro, S.3
  • 24
    • 0024534022 scopus 로고
    • Reporting accuracy among mothers of malformed and nonmalformed infants
    • Werler MM, Pober BR, Nelson K, Holmes LB. Reporting accuracy among mothers of malformed and nonmalformed infants. Am J Epidemiol 1989; 129: 415-21.
    • (1989) Am J Epidemiol , vol.129 , pp. 415-421
    • Werler, M.M.1    Pober, B.R.2    Nelson, K.3    Holmes, L.B.4
  • 25
    • 0018567243 scopus 로고
    • Exogenous hormones and other exposures of children with congenital heart disease
    • Rothman KJ, Fyler DC, Goldblatt A, Kreidberg MB. Exogenous hormones and other exposures of children with congenital heart disease. Am J Epidemiol 1979; 109: 433-9.
    • (1979) Am J Epidemiol , vol.109 , pp. 433-439
    • Rothman, K.J.1    Fyler, D.C.2    Goldblatt, A.3    Kreidberg, M.B.4
  • 27
    • 0019441348 scopus 로고
    • Birth defects related to Bendectin use in pregnancy
    • 1. Oral clefts and cardiac defects
    • Mitchell AA, Rosenberg L, Shapiro S, Slone D. Birth defects related to Bendectin use in pregnancy. 1. Oral clefts and cardiac defects. JAMA 1981; 245: 2311-14.
    • (1981) JAMA , vol.245 , pp. 2311-2314
    • Mitchell, A.A.1    Rosenberg, L.2    Shapiro, S.3    Slone, D.4
  • 28
    • 0026597845 scopus 로고
    • Risks associated with cocaine use during pregnancy
    • Slutsker L. Risks associated with cocaine use during pregnancy. Obstet Gynecol 1992; 79: 778-89.
    • (1992) Obstet Gynecol , vol.79 , pp. 778-789
    • Slutsker, L.1
  • 29
    • 0013392601 scopus 로고
    • Methodologic issues in the epidemiological investigation of drug-induced congenital malformations
    • New York: Oxford University Press
    • Bracken MB. Methodologic issues in the epidemiological investigation of drug-induced congenital malformations. In: Bracken MB, ed., Perinatal Epidemiology. New York: Oxford University Press, 1984.
    • (1984) Perinatal Epidemiology
    • Bracken, M.B.1
  • 31
    • 0027518951 scopus 로고
    • Periconceptional folic acid exposure and risk of occurrent neural tube defects
    • Werler MM, Shapiro S, Mitchell AA. Periconceptional folic acid exposure and risk of occurrent neural tube defects. JAMA 1993; 269: 1257-61.
    • (1993) JAMA , vol.269 , pp. 1257-1261
    • Werler, M.M.1    Shapiro, S.2    Mitchell, A.A.3
  • 32
    • 0018621665 scopus 로고
    • Some abnormal patterns of development in the craniofacial region
    • Johnston MC, Sulik KK. Some abnormal patterns of development in the craniofacial region. Birth Defects Orig Artic Ser 1979; 15: 23-42.
    • (1979) Birth Defects Orig Artic Ser , vol.15 , pp. 23-42
    • Johnston, M.C.1    Sulik, K.K.2
  • 33
    • 0020839664 scopus 로고
    • Gastroschisis: abdominal wall disruption secondary to early gestational interruption of the omphalomesenteric artery
    • Hoyme HE, Jones MC, Jones KL. Gastroschisis: abdominal wall disruption secondary to early gestational interruption of the omphalomesenteric artery. Semin Perinatol 1983; 7: 294-8.
    • (1983) Semin Perinatol , vol.7 , pp. 294-298
    • Hoyme, H.E.1    Jones, M.C.2    Jones, K.L.3
  • 34
    • 85047690453 scopus 로고    scopus 로고
    • Association of vasoconstrictive exposures with risks of gastroschisis and small intestinal atresia
    • Werler MM, Sheehan JE, Mitchell AA. Association of vasoconstrictive exposures with risks of gastroschisis and small intestinal atresia. Epidemiology 2003; 14: 349-54.
    • (2003) Epidemiology , vol.14 , pp. 349-354
    • Werler, M.M.1    Sheehan, J.E.2    Mitchell, A.A.3
  • 35
    • 0026569432 scopus 로고
    • The interaction between dysmorphology and epidemiology: methodologic issues of grouping and splitting
    • Khoury MJ, Moore CA, James LM, Cordero JF. The interaction between dysmorphology and epidemiology: methodologic issues of grouping and splitting. Teratology 1992; 45: 133-8.
    • (1992) Teratology , vol.45
    • Khoury, M.J.1    Moore, C.A.2    James, L.M.3    Cordero, J.F.4
  • 37
    • 0025863475 scopus 로고
    • MRC Vitamin Study Research Group
    • Prevention of neural tube defects: results of the Medical Research Council Vitamin Study
    • MRC Vitamin Study Research Group. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. Lancet 1991; 338: 131-7.
    • (1991) Lancet , vol.338 , pp. 131-137
  • 38
    • 0035873403 scopus 로고    scopus 로고
    • Neural tube defects in relation to use of folic acid antagonists during pregnancy
    • Hernandez-Diaz S, Werler MM, Walker AM, Mitchell AA. Neural tube defects in relation to use of folic acid antagonists during pregnancy. Am J Epidemiol 2001; 153: 961-8.
    • (2001) Am J Epidemiol , vol.153 , pp. 961-968
    • Hernandez-Diaz, S.1    Werler, M.M.2    Walker, A.M.3    Mitchell, A.A.4
  • 39
    • 2642697832 scopus 로고    scopus 로고
    • Prenatal exposure to salicylates and gastroschisis: a case-control study
    • Martinez-Frias ML, Rodriguez-Pinilla E, Prieto L. Prenatal exposure to salicylates and gastroschisis: a case-control study. Teratology 1997; 56: 241-3.
    • (1997) Teratology , vol.56 , pp. 241-243
    • Martinez-Frias, M.L.1    Rodriguez-Pinilla, E.2    Prieto, L.3
  • 40
    • 0036140125 scopus 로고    scopus 로고
    • Maternal medication use and risks of gastroschisis and small intestinal atresia
    • Werler MM, Sheehan JE, Mitchell AA. Maternal medication use and risks of gastroschisis and small intestinal atresia. Am J Epidemiol 2002; 155: 26-31.
    • (2002) Am J Epidemiol , vol.155 , pp. 26-31
    • Werler, M.M.1    Sheehan, J.E.2    Mitchell, A.A.3
  • 41
    • 0023193651 scopus 로고
    • On the ability of birth defects monitoring to detect new teratogens
    • Khoury MJ, Holtzman NA. On the ability of birth defects monitoring to detect new teratogens. Am J Epidemiol 1987; 126: 136-43.
    • (1987) Am J Epidemiol , vol.126 , pp. 136-143
    • Khoury, M.J.1    Holtzman, N.A.2
  • 43
    • 0019866820 scopus 로고
    • Congenital anomalies in relation to the use of doxylamine/dicyclomine and other antenatal factors
    • Gibson GT, Colley DP, McMichael AJ, Hartshorne JM. Congenital anomalies in relation to the use of doxylamine/dicyclomine and other antenatal factors. Med J Aust 1981; 1: 410-14.
    • (1981) Med J Aust , vol.1 , pp. 410-414
    • Gibson, G.T.1    Colley, D.P.2    McMichael, A.J.3    Hartshorne, J.M.4
  • 44
    • 0021790418 scopus 로고
    • Chromosomal abnormalities in the Kaiser-Permanente Birth Defects Study, with special reference to contraceptive use around the time of conception
    • Harlap S, Shiono PH, Ramcharan S, Golbus M, Bachman R, Mann J, Lewis JP. Chromosomal abnormalities in the Kaiser-Permanente Birth Defects Study, with special reference to contraceptive use around the time of conception. Teratology 1985;31: 381-7.
    • (1985) Teratology , vol.31 , pp. 381-387
    • Harlap, S.1    Shiono, P.H.2    Ramcharan, S.3    Golbus, M.4    Bachman, R.5    Mann, J.6    Lewis, J.P.7
  • 45
    • 0023457417 scopus 로고
    • Lack of evidence of teratogenicity of benzodiazepine drugs in Hungary
    • Czeizel A. Lack of evidence of teratogenicity of benzodiazepine drugs in Hungary. Reprod Toxicol 1988; 1: 183-8.
    • (1988) Reprod Toxicol , vol.1 , pp. 183-188
    • Czeizel, A.1
  • 46
    • 84889417103 scopus 로고    scopus 로고
    • Experiences from an existing birth cohort: the Danish National Birth Cohort
    • Presentation at Medicines Exposures Workshop (National Children's Study). Baltimore, MD,December 16
    • Olsen J. Experiences from an existing birth cohort: the Danish National Birth Cohort. Presentation at Medicines Exposures Workshop (National Children's Study). Baltimore, MD,December 16, 2002.
    • (2002)
    • Olsen, J.1
  • 49
    • 0027274075 scopus 로고
    • First trimester topical tretinoin and congenital disorders
    • Jick SS, Terris BZ, Jick H. First trimester topical tretinoin and congenital disorders. Lancet 1993; 341: 1181-2.
    • (1993) Lancet , vol.341 , pp. 1181-1182
    • Jick, S.S.1    Terris, B.Z.2    Jick, H.3
  • 52
    • 84889273943 scopus 로고    scopus 로고
    • FDA. Guidance for industry: Establishing pregnancy exposure registries
    • FDA. Guidance for industry: Establishing pregnancy exposure registries. Available at: http://www.fda.gov/cder/guidance/3626fnl.pdf.
  • 53
    • 0026522941 scopus 로고
    • Epidemiology of isotretinoin exposure during pregnancy
    • Dai WS, LaBraico JM, Stern RS. Epidemiology of isotretinoin exposure during pregnancy. J Am Acad Dermatol 1992; 26: 599-606.
    • (1992) J Am Acad Dermatol , vol.26 , pp. 599-606
    • Dai, W.S.1    LaBraico, J.M.2    Stern, R.S.3
  • 55
    • 0026460256 scopus 로고
    • First-trimester exposure to alprazolam
    • St Clair SM, Schirmer RG. First-trimester exposure to alprazolam. Obstet Gynecol 1992; 80: 843-6.
    • (1992) Obstet Gynecol , vol.80 , pp. 843-846
    • St Clair, S.M.1    Schirmer, R.G.2
  • 63
    • 0027525907 scopus 로고
    • Adaptation of the meconium drug test for mass screening
    • Ostrea EM Jr, Romero A, Yee H. Adaptation of the meconium drug test for mass screening. J Pediatr 1993; 122: 152-4.
    • (1993) J Pediatr , vol.122 , pp. 152-154
    • Ostrea Jr, E.M.1    Romero, A.2    Yee, H.3
  • 64
    • 0024817557 scopus 로고
    • Determination of gestational cocaine exposure by hair analysis
    • Graham K, Koren G, Klein J, Schneiderman J, Greenwald M. Determination of gestational cocaine exposure by hair analysis.JAMA 1989; 262: 3328-30.
    • (1989) JAMA , vol.262 , pp. 3328-3330
    • Graham, K.1    Koren, G.2    Klein, J.3    Schneiderman, J.4    Greenwald, M.5
  • 66
    • 0032812286 scopus 로고    scopus 로고
    • International Society for Pharmacoepidemiology. Data privacy, medical record confidentiality, and research in the interest of public health
    • Andrews EB, International Society for Pharmacoepidemiology. Data privacy, medical record confidentiality, and research in the interest of public health. Pharmacoepidemiol Drug Saf 1999; 8: 247-60.
    • (1999) Pharmacoepidemiol Drug Saf , vol.8 , pp. 247-260
    • Andrews, E.B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.