Periconceptional vitamin a use: How much is teratogenic?

Reproductive Toxicology

Volumn 12, Issue 1, 1998, Pages 75-88

  Miller, Richard K ^a,e   Hendrickx, Andrew G ^b   Mills, James L ^c   Hummler, Hans ^d   Wiegand, Ulf W ^d  

^a UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^d F HOFFMANN LA ROCHE LTD   (Switzerland)

^e UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

Author keywords

Periconceptional vitamin A use; Retinol; Retinyl esters; Tetratogenicity

Indexed keywords

RETINOL; RETINOL ESTER; TERATOGENIC AGENT;

ANIMAL; ARTICLE; CONGENITAL MALFORMATION; DOSE RESPONSE; DRUG SAFETY; EMBRYOTOXICITY; FEMALE; FERTILIZATION; HUMAN; PREGNANCY; PRENATAL DRUG EXPOSURE; PRENATAL EXPOSURE; RETINOL DEFICIENCY; RETINOL INTOXICATION; TERATOGENICITY; TIME;

EID: 0031987260     PISSN: 08906238     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0890-6238(97)00102-0     Document Type: Article

References (90)

1. 1. Blomhoff R. Overview of vitamin A metabolism and function. In: Blomhoff R, ed. Vitamin A in Health and Disease. New York: Marcel Dekker; 1994:1-35.
2. 2. Gorodischer R. Vitamin A in the fetus and newborn. In: Koren G, ed. Retinoids in Clinical Practice. New York: Marcel Dekker; 1993:37-45.
3. 3. Eskild W, Hansson V. Vitamin A functions in reproductive organs. In: Blomhoff R, ed. Vitamin A in Health and Disease. New York: Marcel Dekker; 1994:531-59.
4. 4. Cohlan Q. Excessive intake of vitamin A as a cause of congenital anomalies in the rat. Science (Washington DC). 1953;117:535-6.
5. 5. Teratology Society Position Paper. Recommendations for vitamin A use during pregnancy. Teratology. 1987;35:269-73.
6. 6. Rosa FW, Retinoid embryopathy in humans. In: Koren G, ed. Retinoids in Clinical Practice, New York: Marcel Dekker; 1993: 77-109.
7. 7. Maden M. Vitamin A in embryonic development. Nutr Rev. 1994;52:S3-S12.
8. 8. Nau H, Chahoud I, Dencker L, Lammer EJ, Scott J. Teratogenicity of vitamin A and retinoids. In: Blomhoff R, ed. Vitamin A in Health and Disease. New York: Marcel Dekker. 1994:615-63.
9. 9. Heywood R, Palmer AK, Greson RL, Hummler H. The toxicity of β-carotene. Toxicology. 1985;36:91-100.
10. 10. Beecher GR, Khachik F. Evaluation of vitamin A and carotenoid data in food composition tables. J Natl Cancer Inst. 1984;73:1397-1405.
11. 11. National Research Council. Recommended Dietary Allowances, 10th ed. Washington DC: National Academy Press; 1989:78-92.
12. 12. Code of Federal Regulation. Title 21 101.9.
13. 13. Lammer EJ, Chen DT, Hoar RM, Agnish ND, Benke PJ, Braun JT, Curry CJ, Fernhoff PM, Grix AW Jr, Lott IT, et al. Retinoic acid embryopathy. N Engl J Med. 1985;313:837-41.
14. 14. Adams J. Neural and behavioral pathology following prenatal exposure to retinoids. In: Koren G, ed. Retinoids in Clinical Practice. New York: Marcel Dekker; 1993:111-28.
15. 15. Adam J, Lammer EJ. Neurobehavioral teratology of isotretinoin. Reprod Toxicol. 1993;7:175-7.
16. 16. Carlson BM, ed. Human embryology and Developmental Biology. St. Louis: Mosby-Yearbook; 1994.
17. 17. Hummler H, Korte R, Hendrickx AG. Induction of malformations in the cynomolgus monkey with 13-cis retinoic acid. Teratology. 1990;42:263-72.
18. 18. Nau H. Chemical structure - teratogenicity relationships toxicokinetics and metabolism in risk assessment of retinoids. Toxicol Lett. 1995:82-83;975-979.
19. 19. Rosa FW, Wilk AL, Kelsey FO. Teratogen update: vitamin A congeners. Teratology. 1986;33:355-64.
20. 20. Zuber C, Librizzi RJ, Vogt BL. Outcome of pregnancies exposed of high dose of vitamin A. Teratology. 1987;35:42A.
21. 21. Conway H. Effect of supplemental vitamin therapy on the limitation of incidence of cleft lip and cleft palate in humans. Plast Reconstr Surg. 1958;22:450-3.
22. 22. Sarma V. Maternal vitamin A deficiency and fetal microcephaly and anophthalmia: report of a case. Obstet Gynecol. 1959;13:299-301.
23. 23. Lamba PA, Sood NN. Congenital microphthalmos and colobomata in maternal vitamin A deficiency. J Pediatr Ophthalmol. 1968;5: 115-7.
24. 24. Rabadan F. Malformacion congenita bilateral de al conjunctiva con microcornea y colombo papebral izquierdo y otras anomalias faciales. Anarch Soc Oftalmol His Am. 1952;12:391-4.
25. 25. Kapoor S, Kapoor M. Congenital ocular anomalies in Pondicherry. J Pediatr Ophthalmol. 1977;14:382-389.
26. 26. Hale F. Pigs born without eyeballs. J Hered. 1933;24:105-10.
27. 27. Warkany J. Schaffenberger E. Congenital malformations induced by rats by maternal vitamin A deficiency. I. Defects of the eye. Arch Ophthalmol. 1946;35:150-8.
28. 28. Wilson JG, Warkany J. Malformations of the genitourinary tract induced by maternal vitamin A deficiency in fetal rats. Anal Rec. 1947;97(Suppl):60-8.
29. 29. Wilson JG, Warkany J. Malformations of the genito-urinary tract induced by maternal vitamin A deficiency in the rat. Am J Anat. 1948:83:357-65.
30. 30. Wilson JG, Warkany J. Aortic arch and cardiac anomalies in offspring of vitamin A-deficient rats. Am J Anat. 1949;83:113-20.
31. 31. Martinez-Frias ML, Salvador J. Epidemiologic aspects of prenatal exposure to high doses of vitamin A in Spain. Eur J Epidemiol. 1990;6:118-23.
32. 32. Werler MM, Lammer EJ, Rosenberg L, Mitchell AA. Maternal vitamin A supplementation in relation to selected birth defects. Teratology. 1990;42:497-503.
33. 33. Rothman KJ, Moore LL, Singer MR, Nguyen UDT, Mannino S, Milunsky A. Teratogenicity of high vitamin A intake. New Engl J Med. 1995;333:1369-73.
34. 34. Milunsky A, Jick H, Jick SS, Bruell CL, MacLaughlin DS, Rothman KJ, Willet W. Multivitamin/folic acid supplementation in early pregnancy reduces the prevalence of neural tube defects. J Am Med Assoc. 1989;262:2847-52.
35. 35. Werler MM, Lammer EJ, Mitcheli AA. Letter to the Editor. N Engl J Med. 1996;334:1195-6.
36. 36. Watkins M, Moore C, Mulinare J. Letter to the Editor. N Engl J Med. 1996:1196.
37. 37. Brent RL, Hendrickx AG, Holmes LB, Miller RK. Letter to the Editor. N Engl J Med. 1996;334:1196.
38. 38. Khoury MJ Moore CA Mulinare J. Letter to the Editor. Lancet 1996;347:322.
39. 39. Mulinare J, Cordero JF, Erickson JD, Berry RJ. Periconceptional use of multivitamins and the occurrence of neural tube defects. J Am Med Assoc. 1988;260:3141-5.
40. 40. Shaw GM, Wasserman CR, Block G, Lammer EJ. Lancet. 347, I: 1996:899-900.
41. 41. Mills JL, Simpson JL, Cunningham GC, Conley MR, Rhoads GG. Vitamin A and Birth Defects. Am J Obstet Gynecol. 1997;177: 31-6.
42. 42. Werler MM, Mitchell AA. Case-control study of vitamin supplementation and neural tube defects: consideration of potential confounding by lifestyle factors. Ann NYAS. 1993;678:22.
43. 43. Mills JL, Rhoads GG, Simpson JL, Cunningham GC, Conley MR, Lassman MR, Walden ME, Depp OR, Hoffmann HJ. The absence of a relation between the periconceptional use of vitamins and neural-tube defects. N Engl J Med. 1989;321:430-5.
44. 44. Schorah CJ, Smithells RW. A possible role for periconceptional multivitamin supplementation in the prevention of the recurrence of neural tube defects. In: Bendich A, Butterworth F Jr, eds. Micronutrients in health and in disease prevention. New York: Marcel Dekker; 1991:263-285.
45. 45. Medical Research Council. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. MRC (Medical Research Council) vitamin A Study Research Group. Lancet. 1991;338:131-7.
46. 46. Dudas I, Czeizel AE, Use of 6000 IU vitamin A during early pregnancy without teratogenic effect. Teratology. 1992;45:335-6.
47. 47. Vocci F, Farber T. Extrapolation of animal toxicity data to man. Regul Toxicol Pharmacol. 1988;8:389-98.
48. 48. Brown NA, Fabro S. The value of animal teratogenicity testing for predicting human risk. Clin Obstet Gynecol. 1983;26:467-77.
49. 49. Creech Kraft J, Willhite CC. Retinoids in abnormal and normal embryonic development. In: Lambert GH, Kacew S, eds. Environmental Toxicology and Pharmacology during Development. Washington: Taylor and Francis; 1996:15-49.
50. 50. Armstrong R, Ashenfelter K, Eckhoff C, Levin A, Shapiro S. General and reproductive toxicology of retinoids. In: Sporn MB, Roberts AB, Goodman D, eds. The retinoids, biology, and medicine, 2nd ed. New York: Raven Press; 1994:545-572.
51. 51. Buss NE, Tembe EA, Prendergast BD, Renwick AG, George CF. The teratogenic metabolites of vitamin A in women following supplements and liver. Human Exp Toxicol. 1994;13:33-43.
52. 52. Eckhoff C, Baily JR, Collins MD, Slikker W, Nau H. Influence of dose and pharmaceutical formulation of vitamin A on plasma levels of retinyl esters and retinol and metabolic generation of retinoic acid compounds and β-glucuronides in the cynomolgus monkey. Toxicol Appl Pharmacol. 1991;111:116-27.
53. 53. Blomhoff R, Green MH, Berg T, Norum KR. Transport and storage of vitamin A. Science (Washington DC). 1990;250:399-404.
54. 54. Blomhoff R, Green MH, Green JB, Berg T, Norum KR. Vitamin A metabolism: new perspectives on absorption, transport, and storage. Physiol Rev. 1991;71:951-90.
55. 55. Ong DE. Absorption of Vitamin A. In: Blomhoff R, ed. Vitamin A in health and disease. New York: Marcel Dekker; 1994:37-72.
56. 56. Wang XD, Tang G, Fox JG, Krinsky NI, Russell RM. Enzymatic conversion of β-carotene into β-apo-carotenals and retinoids by human, monkey, ferret and rat tissues. Arch Biochem Biophys. 1991;285:8-16.
57. 57. Bendich A. Safety of β-Carotene. Nutr Rev. 1988;11:207-14.
58. 58. Wake K. Role of perisinusoidal stellate cells in vitamin A Storage. In: Blomhoff R, ed. Vitamin A in health and disease. New York: Marcel Dekker; 1994:73-86.
59. 59. Tang G, Russel RM. Formation of all-trans-retinoic acid and 13-cis-retinoic acid from all-trans-retinyl palmitate in humans. J Nutr Biochem. 1991;2:210-3.
60. 60. Krasinski SD, Russell RM, Otradovec CL, Sadowski JA, Hartz SC, Jacob RA, McGandy RB. Relationship of vitamin A and vitamin E intake to fasting plasma retinol, retinol-binding protein, retinyl esters, carotene, alpha-tocopherol, and cholesterol among elderly people and young adults: increased plasma retinyl esters among vitamin A-supplement users. Am J Clin Nutr. 1989;49:112-20.
61. 61. Bendich A, Langseth L. Safety of vitamin A. Am J Clin Nutr. 1989;49:358-71.
62. 62. Sommer A, West KP Jr. Vitamin A deficiency. Health survival and vision. Oxford, UK: Oxford University Press; 1996:96-149.
63. 63. Rando RR. Retinoid Isomerization reactions in the visual system. In: Blomhoff R, ed. Vitamin A in Health and Disease. New York: Marcel Dekker; 1994:503-29.
64. 64. Olson JA. Vitamin A. In: Machlin L, ed. Handbook of vitamins: nutritional, biochemical, and clinical aspects. New York: Marcel Dekker; 1984:1-43.
65. 65. Alaimo K, McDowell MA, Briefel RR, Bischof AM. Dietary intake of vitamins, minerals and fiber of persons ages 2 months and over in the United States: Third National Health and Nutrition Examination Survey, Phase 1, 1988-1991; vital and health statistics of the centers for disease control and prevention/national center for health statistics No: 258, November 1994:14.
66. 66. Netherlands Health Council. Vitamin A and teratogenicity. Health Council and Food and Nutrition Council. The Hague, The Netherlands, 1994.
67. 67. Wyss R, Bucheli F. Quantitative analysis of retinoids in biologic fluids by high-performance liquid chromatography (HPLC) using column switching. J Chromatography. 1988;456:33-43.
68. 68. Ranalder UB, Lausecker BB, Huselton C. Microliquid chromatography-mass spectrometry with direct liquid introduction used for separation and quantitation of all-trans and 13-cis-retinoic acids and their 4-Oxo metabolites in human plasma. J Chromatography. 1993;617:129-35.
69. 69. Eckhoff C, Nau H. 13 Cis retinoic acid is an endogenous compound in human serum. J Lipid Res. 1990;31:174-82.
70. 70. Hartmann S, Broers O, Blomhoff R, Wiegand UW. Retinoid plasma concentrations following multiple oral vitamin A doses. FASEB J. 1997.
71. 71. Tembe EA, Honey well R, Buss NE, Renwick AG. All-trans-retinoic acid in maternal plasma and teratogenicity in rats and rabbits. Toxicol Appl Pharmacol. 1996;141:456-72.
72. 72. Wiegand UW, Hartmann S, Wyss R. Endogenous concentrations of retinoids during pregnancy and their relevance for the risk assessment of vitamin A in women. Presentation at symposium: "Pharmacokinetics/Pharmacodynamics in the Developing System and Impact on Risk Assessment." April 1996; Little Rock.
73. 73. Wiegand UW, Cuntiffe W, Wyss R, Crevoisier C. Treatment of female patients with isotretinoin: what is the safe post-therapy contraceptive period? Clinical Dermatology 2000. May 1996; Vancouver: p. 7.
74. 74. Hendrickx AG, Hummler H. Teratogenicity of all-trans retinoic acid during early embryonic development in the cynomolgus monkey (Macaca fascicularis). Teratology. 1992;45:65-74.
75. 75. Hummler H, Hendrickx AG, Nau H. Maternal toxicokinetics, metabolism, and embryo exposure following a teratogenic dosing regimen with 13-cis-retinoic acid (isotretinoin) in the cynomolgus monkey. Teratology. 1994;50:184-93.
76. 76. Kraft JC, Nau H, Lammer E, Olney A. Embryonic retinoid concentrations after maternal intake of isotretinoin. N Engl J Med. 1989;321:262.
77. 77. Kraft JC Shepard T, Juchau MR. Tissue levels of retinoids in human embryo/fetuses. Reprod Toxicol. 1993;7:11-15.
78. 78. Hendrickx AG, Hummler H. Teratogenicity of hypervitaminosis A in the monkey. FASEB J. 1997;11:A412.
79. 79. Geelen JAG. Hypervitaminosis A induced teratogenesis. CRC Crit Rev Toxicol. 1979;6:351-75.
80. 80. Hutchings DE, Gaston J. The effects of vitamin A excess administered during the mid-fetal period on learning and development in rat offspring. Dev Psychobiol. 1974;7:225-33.
81. 81. Vorhees CV, Brunner RL, McDaniel CR, Butcher RE. The relationship of gestational age to vitamin A-induced postnatal dysfunction. Teratology. 1978;17:271-76.
82. 82. Kistler A. Embryo toxicity study in mice with oral administration of Ro 01-5892, vitamin A palmitate, AROVlT. Phase II teratological study. Teratology. 1981;23:25-31.
83. 83. Kamm JJ. Toxicology, carcinogenicity and teratogenicity of some orally administered retinoids. J Am Acad Dermatol. 1982;6:652-9.
84. 84. Willhite CC, Sheaiy YF. Amelioration of embryo toxicity by structural modification of the terminal group of cancer chemopreventive retinoids. J Natl Cancer Inst. 1984;72:689-95.
85. 85. Panel on Nonhuman Primate Nutrition et al. Nutrient requirements of nonhuman primates. In: Nutrient requirements of domestic animals, no. 14. Washington DC: National Academy of Sciences; 1978:43-4.
86. 86. Mounoud R, Klein D, Weber F. A propos d'un cas de syndrome de Goldenhar: intoxication aigue à la vitamine A chez la mère pendant la grossesse. J Génét Hum. 1975;23:135-54.
87. 87. Stange L, Carlstrom K, Eriksson M. Hypervitaminosis A in early human pregnancy and malformations of the central nervous system. Acta Obstet Gynecol Scand. 1978;57:289-91.
88. 88. Van Lennep E, Lel Khazen N, De Pierreux G, Amy JJ, Rodesch F. Van Regemorte N. A case of partial sirenomelia and possible vitamin A teralogenesis. Prenatal Diagn. 1985;5:35-40.
89. 89. Bernhardt IB, Dorsey DJ. Hypervitaminous and congenital renal anomalies in a human infant. Obstet Gynecol. 1974;43:750-5.
90. 90. Pilotti G, Scorta A. Ipervitaminosi A gravidica e malformazioni neonatali dell'attarato urinario. Min Gin. 1965;87:1103-8.