Studies of Drug-Induced Birth Defects

Pharmacoepidemiology, Fifth Edition

Volumn , Issue , 2012, Pages 487-504

  Mitchell, Allen A ^a,b  

^a BOSTON UNIVERSITY   (United States)

^b BOSTON UNIVERSITY   (United States)

Author keywords

Antenatal medication; Birth defect; Pregnancy; Teratogen

Indexed keywords

EID: 84868193504     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781119959946.ch28     Document Type: Chapter

References (77)

1. 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. 30-2.
2. CDC. Surveillance summaries: Improved national prevalence estimates for 18 selected major birth defects - United States 1999 -2001. MMWR 2006; 54: 1301-05.
3. Gregg NM. Congenital cataract following German measles in the mother. Trans Ophthalmol Soc Aust 1941; 3: 35-46.
4. Lenz W. Thalidomide and congenital abnormalities. Lancet 1962; 1: 45.
5. Warkany J. Problems in applying teratologic observations in animals to man. Pediatrics 1974; 53: 820.
6. Mitchell AA. Systematic identifi cation of drugs that cause birth defects -a new opportunity. N Engl J Med 2003; 349: 2556-9.
7. Stern RS. When a uniquely effective drug is teratogenic: the case of isotreninoin. N Engl J Med 1989; 320: 1007-9.
8. Mitchell AA, Van Bennekom C, Louik C. A pregnancy - prevention program in women of childbearing age receiving isotretinoin. N Engl J Med 1995; 333: 101-6.
9. Mitchell AA, Van Bennekom C. Isotretinoin Survey. Presentation at FDA Advisory Committees. Gaithersburg, MD, February 26, 2004.
10. Risk Evaluation and Mitigation Strategy (REMS).The iPLEDGE Program. Single Shared System for Isotretinoin. http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsand Providers/UCM234639.pdf(accessed July 2011).
11. FDA. iPLEDGE. http://www.fda.gov/Drugs/Drug Safety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm094307.htm (accessed Aug 10).
12. Holmes LB. Teratogen update: Bendectin. Teratology 1983; 27: 277-81.
13. Neutel CI, Johansen HL. Measuring drug effectiveness by default: the case of Bendectin. Can J Pub Health 1995; 86: 66-70.
14. Hook EB, Healy KB. Consequences of a nationwide ban on spray adhesives alleged to be human teratogens and mutagens. Science 1976; 191: 566-7.
15. 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.
16. Newman CGH. Teratogen update: clinical aspects of thalidomide embryopathy -a continuing preoccupation. Teratology 1985; 32: 133-44.
17. Lammer EJ, Chen DT, Hoar RM, Agnish ND, Benke PJ, Braun JT et al. Retinoic acid embryopathy. N Engl J Med 1985; 313: 837-41.
18. Robert E. [Example of teratogen detection using a birth defects registry: depakine and spina bifi da.] Rev Epidemiol Sante Publique 1996; 44 (Suppl 1): 78-81 [in French].
19. Whitfi eld MF. Chondrodysplasia punctata after warfarin in early pregnancy. Arch Dis Child 1980; 55: 139-42.
20. Martin RA, Jones KL, Mendoza A, Barr M, Benirschke K. Effect of ACE inhibition on the fetal kidney: decreased renal blood fl ow. Teratology 1992; 46: 317-21.
21. Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernández-Díaz S. Medication use during pregnancy, with particular focus on prescription drugs: 1976 -2008, National Birth Defects Prevention Study. Am J Obstet Gynecol 2011 Apr 21. [Epub ahead of print] PMID: 21514558.
22. RayburnW,Wible -Kant J, Bledsoe P. Changing trends in drug use during pregnancy. J Reprod Med 1982; 27: 569-75.
23. Werler, MM, Mitchell AA, Hernandez-Diaz S, Honein MA and the National Birth Defects Prevention Study. Use of over -the-counter medications in pregnancy. Am J Obstet Gynecol 2005; 193: 771-7.
24. Broussard CS, Louik C, Honein MA, Mitchell AA and the National Birth Defects Prevention Study. Herbal use before and during pregnancy. Am J Obstet Gynecol 2010; 202: 439.e1-10.
25. Louik C, Gardiner P, Kelley K, Mitchell AA. Use of herbal treatments in pregnancy. Am J Obstet Gynecol 2010; 202: 443.e1-6.
26. Mitchell AA, Cottler LB, Shapiro S. Effect of questionnaire design on recall of drug exposure in pregnancy . Am J Epidemiol 1986; 123: 670-6.
27. Goldsworthy RC, Schwartz NC, Mayhorn CB. Beyond abuse and exposure: Framing the impact of prescription-medication sharing. Am J Publ Health 2008: 98: 1115-21.
28. Daniel KL, Honein MA, Moore CA. Sharing prescription medication among teenage girls: Potential danger to unplanned/undiagnosed pregnancies. Pediatrics 2003; 111: 1167-70.
29. Petersen EE, Rasmussen SA, Daniel KL, Yazdy MM, Honein MA. Prescription medication borrowing and sharing among women of reproductive age. J Womens Health 2008; 17: 1073-80.
30. Fischer MA, Stedman MR, Lii J, Vogeli C, Shrank WH, Brookhart MA, et al. Primary medication non - adherence: Analysis of 195,930 electronic prescriptions. J Gen Intern Med 2010; 25: 284-90.
31. Toh S, Mitchell AA, Werler MM, Hernandez-Diaz S. Sensitivity and specifi city of computerized algorithms to classify gestational periods in the absence of information of date of conception. Am J Epidemiol 2008; 167: 633-40.
32. Werler MM, Pober BR, Nelson K, Holmes LB. Reporting accuracy among mothers of malformed and nonmalformed infants. Am J Epidemiol 1989; 129: 415-21.
33. 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.
34. Bingol N, Fuchs M, Diaz V, Stone RK, Gromisch DS. Teratogenicity of cocaine in humans. J Pediatr 1987; 110: 93-6.
35. 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.
36. Slutsker L. Risks associated with cocaine use during pregnancy. Obstet Gynecol 1992; 79: 778-89.
37. 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, pp. 435-40.
38. Mills JL, Rhoads GG, Simpson JL, Cunningham GC, Conley MR, Lassman MR, et al. The absence of a relation between the periconceptional use of vitamins and neural tube defects. N Engl J Med 1989; 321: 430-5.
39. Werler MM, Shapiro S, Mitchell AA. Periconceptional folic acid exposure and risk of occurrent neural tube defects. JAMA 1993; 269: 1257-61.
40. Johnston MC, Sulik KK. Some abnormal patterns of development in the craniofacial region. Birth Defects Orig Artic Ser 1979; 15: 23-42.
41. 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.
42. Werler MM, Sheehan JE, Mitchell AA. Association of vasoconstrictive exposures with risks of gastroschisis and small intestinal atresia. Epidemiology 2003; 14: 349-54.
43. 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.
44. Slone D, Shapiro S, Miettinen OS, Finkle WD, Stolley PD. Drug evaluation after marketing. Ann Intern Med 1979; 90: 257-61.
45. MRC Vitamin Study Research Group. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. Lancet 1991; 338: 131-7.
46. Hernandez-Diaz S, Werler MM, Walker AM, Mitchell AA. Neural tube defects in relation to use of folic acidantagonists during pregnancy. Am J Epidemiol 2001; 153: 961-8.
47. Martinez-Frias ML, Rodriguez-Pinilla E, Prieto L. Prenatal exposure to salicylates and gastroschisis: a case-control study. Teratology 1997; 56: 241-3.
48. Werler MM, Sheehan JE, Mitchell AA. Maternal medication use and risks of gastroschisis and small intestinal atresia. Am J Epidemiol 2002; 155: 26-31.
49. Khoury MJ, Holtzman NA. On the ability of birth defects monitoring to detect new teratogens. Am J Epidemiol 1987; 126: 136-43.
50. Michaelis J, Gluck E, Michaelis H, Koller S, Degenhardt K-H. Teratogene Effekte von Lenotan. Dtsch Arztebl 1980; 23: 1527-9.
51. 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.
52. Harlap S, Shiono PH, Ramcharan S, Golbus M, Bachman R, Mann J, et al. 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.
53. Czeizel A. Lack of evidence of teratogenicity of benzodiazepine drugs in Hungary. Reprod Toxicol 1988; 1: 183-8.
54. Rebordosa CMG, Kogevinas M, Bech BH, Sørensen HT, Olsen J. Use of acetaminophen during pregnancy and risk of adverse pregnancy outcomes. Int J Epidemiol 2009; 38: 1-9.
55. The National Children 's Study. http://www. nationalchildrensstudy.gov/Pages/default.aspx (accessed Aug 2010).
56. Slone D, Siskind V, Heinonen OP, Monson RR, Kaufman DW, Shapiro S. Aspirin and congenital malformations. Lancet 1976; 1: 1373-5.
57. Jick H, Holmes LB, Hunter JR, Madsen S, Stergachis A. First-trimester drug use and congenital disorders. JAMA 1981; 246: 343-6.
58. Jick SS, Terris BZ, Jick H. First trimester topical tretinoin and congenital disorders. Lancet 1993; 341: 1181-2.
59. Ratanajamit C, Skriver MV, Norgaard M, Jepsen P, Schonheyder HC, Sorensen HT. Adverse pregnancy outcome in users of sulfamethizole during pregnancy: a population -based observational study. J Antimicrob Chemother 2003; 52: 837-41.
60. Pasternak B, Hviid A. Use of proton -pump inhibitors in early pregnancy and the risk of birth defects. N Engl J Med 2010; 363: 2114-23.
61. Kuehn BM: Studies probe medication use in pregnancy . JAMA 2010; 303: 601.
62. FDA. Pregnancy Registries. http://www.fda.gov/ ScienceResearch/SpecialTopics/WomensHealth Research/ucm251314.htm (accessed July 2011).
63. Dai WS, LaBraico JM, Stern RS. Epidemiology of isotretinoin exposure during pregnancy. J Am Acad Dermatol 1992; 26: 599-606.
64. Chambers C, Braddock SR, Briggs GG, Einarson A, Johnson YR, Miller RK, et al. Postmarketing surveillance for human teratogenicity: a model approach. Teratology 2001; 64: 252-61.
65. Chambers CD, Johnson KA, Dick LM, Felix RJ, Jones KL. Birth outcomes in pregnant women taking fl uoxetine. N Engl J Med 1996; 335: 1010-5.
66. Chambers CD, Hernandez-Diaz S, Van Marter LJ, Werler MM, Louik C, Jones KL, et al. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med 2006; 354: 579-87.
67. Yoon PW, Rasmussen SA, Lynberg MC, Moore CA, Anderka M, Carmichael SL, et al. The national birth defects prevention study. Public Health Rep 2001; 116 (Suppl 1): 32-40.
68. Jick H, Walker AM, Rothman KJ, Hunter JR, Holmes LB, Watkins RN, et al. Vaginal spermicides and congenital disorders. JAMA 1981; 245: 1329-32.
69. Mills JL, Harley EE, Reed GF, Berendes HW. Are spermicides teratogenic? JAMA 1982; 248: 2148-51.
70. Shapiro S, Slone D, Heinonen OP, Kaufman DW, Rosenberg L, Mitchell AA, et al. Birth defects and vaginal spermicides. JAMA 1982; 247: 2381-4.
71. Louik C, Mitchell AA, Werler MM, Hanson JW, Shapiro S. Maternal exposure to spermicides in relation to certain birth defects. N Engl J Med 1987; 317: 474-8.
72. Warburton D, Neugut RH, Lustenberger A, Nicholas A, Kline J. Lack of association between spermicide use and trisomy. N Engl J Med 1987; 317: 478-82.
73. Lester BM, ElSohly M, Wright LL, Smeriglio VL, Verter J, Bauer CR, et al. The Maternal Lifestyle Study: Drug use by meconium toxicology and maternal self -report. Pediatrics 2001; 107: 309-17.
74. Frison G, Vavretto D, Vogliardi S, Terranova C, Ferrara SD. Quantifi cation of citalopram or escitalopram and their demethylated metabolites in neonatal hair samples by liquid chromatography -tandem mass spectrometry. Ther Drug Monit 2008; 30: 467-73.
75. Strickler SM, Dansky LV, Miller MA, Seni MH, Andermann E, Spielberg SP. Genetic predisposition tophenytoin-induced birth defects. Lancet 1985; 2: 746-9.
76. Andrews EB. International Society for Pharmacoepidemiology. Data privacy, medical record confi dentiality, and research in the interest of public health. Pharmacoepidemiol Drug Saf 1999; 8: 247-60.
77. Schatz M, Chambers CD, Jones KL, Louik C, Mitchell AA. Safety of infl uenza immunizations and treatment during pregnancy: The vaccines and medications in pregnancy surveillance system. Am J Obstet Gynecol 2011: S64-8.