TERATOGENIC PROPERTIES OF DRUGS. BACKGROUND INFORMATION
https://doi.org/10.15690/pf.v10i1.588
Abstract
The article presents the most significant steps in the development of ideas about drugs’ effects on fetus. It features the thalidomide tragedy and features of thalidomide teratogenic properties, as well as data on thalidomide syndrome prevention relevance in the 21st century. The article covers teratogenesis principles and gives information about the discovery of teratogenic properties and their manifestation in several other major teratogens: retinoids, carbamazepine, valproic acid, diethylstilbestrol.
About the Authors
A. A. Ivanova
St. Petersburg State University
Russian Federation
postgraduate student at the faculty of medicine, St. Petersburg State University
Russian Federation
postgraduate student at the faculty of medicine, St. Petersburg State University
A. V. Mikhailov
SFHI «Maternity Hospital № 17», St. Petersburg, Russian Federation; Mechnikov North-West State Medical University, St. Petersburg, Russian Federation
A. S. Kolbin
Regional Centre for Drug Monitoring and Safety, St. Petersburg, Russian Federation
References
1. Guidance for industry reproductive and developmental toxities — integrating study results to assess concerns. U. S. Department of health and human services, food and drug administration, center for drug evalution and research (CDER). Pharmacology and Toxicology. 2011 Sept. 20 p.
2. Schaefer C., Spielmann H., Vetter K. Lekarstvennaya terapiya v period beremennosti i laktatsii. Per. s nem. pod red. B.K. Romanova [Drug Therapy during Pregnancy and Lactation. Translated from German, edited by B.K. Romanov]. Moscow, Logosfera, 2010. 768 p.
3. Shaefer C., Peters P., Miller R. C. Drugs during pregnancy and lactation. Treatment options and risk assessment. Second edition. Elsevier, 2007. 875 р.
4. Astakhova A.V., Lepakhin V.K. Pregnancy and medication. In book: Medicines. Adverse drug reactions well as a monitoring security. Bezopasnost' lekarstv i farmakonadzor = Drug safety and pharmacovigilance. 2009; 2: 3–20.
5. Sher S.A. Teratogenic effects of drugs on the body of the child in utero. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2011; 8 (6): 57–60.
6. Dally A. Thalidomide: was the tragedy preventable? Lancet. 1998; 351: 1197– 9.
7. Kirillova I.A., Kravtsova G.I., Kruchinskii G.V. et al. Teratologiya cheloveka. Rukovodstvo dlya vrachei. Pod red. G. I. Lazyuka. 2-e izd., pererab. i dop. il. [Human Teratology. Guide for Physicians. Edited by G.I. Lazyuk. 2nd ed., rev. and enl., illustrated]. Moscow, Meditsina, 1991. 480 p.
8. Schumacher G. H. Teratology in cultural documents and today. Ann. Anat. 2004; 186 (5–6): 539–46.
9. Garfield E. Teratology literature and the thalidomide controversy. Essays of an Information Scientist. 1986; 9: 404–412.
10. Friedman J. M. The principles of teratology: are they still true? Birth. Defects Res. A Clin. Mol. Teratol. 2010; 88 (10): 766–768.
11. Squier S. M. Poultry science, chicken culture: a partial alphabet. Rutgers University Press, 2011. Р. 84.
12. Stephens T., Brynner R. Dark remedy: the impact of thalidomide and its revival as a vital medicine. USA, Basic Books, 2001. 240 р.
13. Greek R., Shanks N., Rice M. J. The history and implications of testing thalidomide on animals. The Journal of Philosophy, Scince & Law. 2011; 11. Available at: http://www.miami.edu/ethics/jpsl
14. Whipple G. H. Pregnancy and chloroform anesthesia: a study of the maternal, placental, and fetal tissues. J. Exp. Med. 1912; 15 (3): 246–258.
15. Wilson J. G. The evolution of teratological testing. Teratology. 1979; 20 (2): 205–211.
16. Briggs G. G., Freeman R. K., Yaffee S. J. Drugs in pregnancy and lactation. Eight edition. Philadelphia, LippincottWilliams & Wilkins, 2008. 2217 p.
17. Vianna F. S., Lopez-Camelo J. S., Leite J. C. et al. Epidemiological surveillance of birth defects compatible with thalidomide embryopathy in Brazil. PLoS One. 2011; 6 (7): e21735.
18. Kalter H. Teratology in the 20th century: environmental causes of congenital malformations in humans and how they were established. Neurotoxicol. Teratol. 2003; 25 (2): 131–282.
19. Avorn J. Learning about the safety of drugs — a half-century of evolution. N Engl J Med. 2011; 365: 2151–2153.
20. McBride W. G. Thalidomide and congenital abnormalities. Lancet. 1961; 2: 358.
21. Lenz W. Thalidomide and congenital abnormalities. Lancet. 1962; 1: 45.
22. Klingberg M. A. An epidemiologist's journey from typhus to thalidomide, and from the Soviet Union to Seveso. JLL Bulletin: Commentaries on the history of treatment evaluation (www.jameslindlibrary.org). 2010.
23. Zheng C. F., Xu J. H., Huang Y. et al. Treatment of pediatric refractory Crohn’s disease with thalidomide. World J. Gastroenterol. 2011; 17 (10): 1286–1291.
24. Metodicheskie rekomendatsii po izucheniyu obshchetoksicheskogo deistviya farmakologicheskikh sredstv. Utverzhdeny Upravleniem gosudarstvennogo kontrolya lekarstvennykh sredstv i meditsinskoi tekhniki Minzdrava Rossii 29 dekabrya 1997 g. [Guidelines for the Study of the General Toxicity of Pharmacological Agents. Approved by the Office of the State Control of Medicines and Medical Equipment of Russian Ministry of Health dated December 29, 1997].
25. Ryon M. G., Sawhney D. S. Scientific rationale for the selection of toxicity testing methods II. Teratology, immunotoxicology, and inhalation toxicology. United States Environmental Protection Agency, Washington DC, 1985. 253 p.
26. Lo W. Y., Friedman J. M. Teratogenicity of recently introduced medications in human pregnancy. Obstet Gynecol. 2002; 100 (3): 465–73.
27. Strizhenok E.A., Gudkov I.V., Strachunskii L.S. pplication of drugs during pregnancy: results of a multicenter pharmacoepidemiological study. Klin. mikrobiol. antimikrob. khimioter. = Clinical microbiology and antimicrobial chimiotherapy. 2007; 9 (2): 162–175.
28. Federal'nyi zakon Rossiiskoi Federatsii ot 12 aprelya 2010 g. № 61-FZ «Ob obrashchenii lekarstvennykh sredstv». St. 43, p. 6 [Federal Law dated April 12, 2010 № 61-FZ "On Circulation of Medicines". Art. 43, p. 6].
29. Reviewer guidance evaluating the risk of drug exposure in human pregnancies. U. S. Department of health and human services, food and drug administrtion, center for drug evaluation and research (CDER). Center for Biologics Evaluation and Research (CBER). 2005. 28 р.
30. Zagorodnikova K.A., Burbello A.T., Pokladova M.V. Safety of medicines and pharmacovigilance in pregnant women - from "talidomidovoy tragedy" to the present day. Remedium = Remedium. 2012; 8 (186): 15–22.
31. Jelinek R. The contribution of new findings and ideas to the old principles of teratology. Reprod Toxicol. 2005; 20 (3): 295–300.
32. Val'kovich E.I. Teratogenesis and teratogenicity. Pediatr = Pediatrician. 2010; 1: 13–15.
33. van Gelder M. M., van Rooij I. A., Miller R. K. et al. Teratogenic mechanisms of medical drugs. Hum. Reprod Update. 2010; 16 (4): 378–94.
34. Chetley A. Problemnye lekarstva [Problem Drugs]. Landmark Ltd, 1998. 256 p. Available at official web site: www.antibiotic.ru.
35. Hormonally active agents in the environment. Committee on hormonally active agents in the environment, board on environmental studies and toxicology, commission on life scinces, national research council. National academy press, 1999. 435 р.
36. Scientific frontiers in developmental toxicology and risk assessment. Committee on devel-opmental toxicology, board on environmental studies and toxicology, national research council. Washington, DC, National Academies Press, 2000. 354 р.
37. Zavidova S.S., Namazova-Baranova L.S., Topolyanskaya S.V. Clinical studies of drugs in pediatrics: challenges and achievements. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2010; 7 (1): 6–14.
Review
For citations:
Ivanova A.A., Mikhailov A.V., Kolbin A.S. TERATOGENIC PROPERTIES OF DRUGS. BACKGROUND INFORMATION. Pediatric pharmacology. 2013;10(1):46-53. https://doi.org/10.15690/pf.v10i1.588
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