Sensitive periods for developmental toxicity of orally administered artesunate in the rat

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 83, Issue 4, 2008, Pages 407-417

  White, Tacey E K ^a   Clark, Robert L ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Artemisinin; Artesunate; Embryotoxicity; Heart; Long bone; Malaria; Malformations; Teratogenicity

Indexed keywords

ARTESUNATE;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CARDIOVASCULAR MALFORMATION; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE COMPARISON; EMBRYO; EMBRYOTOXICITY; FEMALE; FETUS; LETHALITY; NONHUMAN; ORGANOGENESIS; PRENATAL PERIOD; PRIORITY JOURNAL; RAT; SENSITIVITY ANALYSIS; SINGLE DRUG DOSE; SKELETON MALFORMATION;

ADMINISTRATION, ORAL; ANIMALS; ARTEMISININS; CESAREAN SECTION; EMBRYO LOSS; FEMALE; FETUS; MUSCULOSKELETAL ABNORMALITIES; PREGNANCY; PRENATAL EXPOSURE DELAYED EFFECTS; RATS; TIME FACTORS;

ARTESUNATE; RATTUS;

EID: 51449124524     PISSN: 15429733     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdrb.20157     Document Type: Article

References (55)

1. Ashley EA, White NJ. 2005. Artemisinin-based combinations. Curr Opin Infect Dis 18:531-536.
2. Bialek R, Knobloch J. 1999. [Parasitic infections in pregnancy and congenital protozoan infections. Part I: Protozoan infections]. Z Geburtshilfe Neonatal 203:55-62.
3. Bounyasong S. 2001. Randomized trial of artesunate and mefloquine in comparison with quinine sulfate to treat P. falciparum malaria pregnant women. J Med Assoc Thai 84:1289-1299.
4. Brabin B. 1997. Malaria in pregnancy: current issues. Afr Health 19:19-20.
5. Brabin B, Piper C. 1997. Anemia- and malaria-attributable low birthweight in two populations in Papua New Guinea. Ann Hum Biol 24:547-555.
6. Chen LJ, Wang MY, Sun WK, Liu MZ. 1984. [Embryotoxicity and teratogenicity studies on artemether in mice, rats and rabbits]. Zhongguo Yao Li Xue Bao 5:118-122.
7. Clark RL, Arima A, Wier PJ. 2007. Artesunate: lack of developmental toxicity in Cynomolgus monkeys when administered at 12 mg/kg/day for 3 and 7 days during the putative sensitive period. Birth Defects Res A Clin Mol Teratol 79:423.
8. Clark RL, Kumemura M, Makori N, Nakata Y, Bernard F, Harrell A, White TEK, Arima A. 2006. Artesunate: Developmental toxicity in monkeys. Birth Defects Res A Clin Mol Teratol 76:329.
9. Clark RL, White TE, Clode A, Gaunt I, Winstanley P, Ward SA. 2004. Developmental toxicity of artesunate and an artesunate combination in the rat and rabbit. Birth Defects Res B Dev Reprod Toxicol 71:380-394.
10. Colnot CI, Helms JA. 2001. A molecular analysis of matrix remodeling and angiogenesis during long bone development. Mech Dev 100:245-250.
11. Conover WJ. 1980. Practical nonparametric statistics. New York: Wiley and Sons.
12. Danielsson BR, Skold AC, Azarbayjani F. 2001. Class III antiarrhythmics and phenytoin: teratogenicity due to embryonic cardiac dysrhythmia and reoxygenation damage. Curr Pharm Des 7:787-802.
13. Deen JL, von Seidlein L. 2002. Antimalarial use during pregnancy and its effect on birthweight. Trans R Soc Trop Med Hyg 96:573-574.
14. Deen JL, von Seidlein L, Pinder M, Walraven GE, Greenwood BM. 2001. The safety of the combination artesunate and pyrimethamine-sulfadoxine given during pregnancy. Trans R Soc Trop Med Hyg 95:424-428.
15. Dunnett CW. 1965. A multiple comparisons procedure comparing several treatments with a control. J Am Stat Soc 55:1096-1121.
16. Ghatpande SK, Billington Jr CJ, Rivkees SA, Wendler CC. 2008. Hypoxia induces cardiac malformations via A1 adenosine receptor activation in chicken embryos. Birth Defects Res A Clin Mol Teratol 82:121-130.
17. Granja AC, Machungo F, Gomes A, Bergstrom S, Brabin B. 1998. Malaria-related maternal mortality in urban Mozambique. Ann Trop Med Parasitai 92:257-263.
18. Guerin PJ, Olliaro P, Nosten F, Druilhe P, Laxminarayan R, Binka F, Kilama WL, Ford N, White NJ. 2002. Malaria: current status of control, diagnosis, treatment, and a proposed agenda for research and development. Lancet Infect Dis 2:564-573.
19. Hollander M, Wolfe DA. 1999. Nonparametric statistical methods. New York: Wiley and Sons.
20. Kawamura S, Kato T, Matsuo M, Sasaki M, Katsuda Y, Hoberman AM, Yasuda M. 1995. Species difference in developmental toxicity of an N-phenylimide herbicide between rats and rabbits and sensitive period of the toxicity to rat embryos. Congenit Anom 35:123-132.
21. Kawamura S, Yoshioka T, Kato T, Matsuo M, Yasuda M. 1996. Histological changes in rat embryonic blood cells as a possible mechanism for ventricular septal defects produced by an N-phenylimide herbicide. Teratology 54:237-244.
22. Kelemen E, Calvo W, Fliedner TM. 1979. Atlas of human hemopoietic development. Berlin: Springer-Verlag.
23. Laffan SB, Chadderton AR, White TE, Solomon HM, Clark RL. 2005. In vitro sensitivity of rat embryonic blood cells to the anti-malarial drug Artesunate. Birth Defects Res A Clin Mol Teratol 73:296.
24. Langman J. 1982. Medical Embryology. 4th ed. Baltimore: Williams and Wilkins.
25. Li QG, Peggins JO, Fleckenstein LL, Masonic K, Heiffer MH, Brewer TG. 1998. The pharmacokinetics and bioavailability of dihydroartemisinin, arteether, artemether, artesunic acid and artelinic acid in rats. J Pharm Pharmacol 50:173-182.
26. Li ZL. 1988. [Teratogenicity of sodium artesunate]. Zhong Yao Tong Bao 13:42-44.
27. Littell RC, Milliken GA, Stroup WW, Wolfinger RD. 1996. SAS system for MIXED models. SAS Institute, Inc.
28. Longo M, Zanoncelli S, Torre PD, Riflettuto M, Cocco F, Pesenti M, Giusti A, Colombo P, Brughera M, Mazue G, Navaratman V, Gomes M, Olliaro P. 2006. In vivo and in vitro investigations of the effects of the antimalarial drug dihydroartemisinin (DHA) on rat embryos. Reprod Toxicol 22:797-810.
29. Maes C, Carmeliet P, Moermans K, Stockmans I, Smets N, Collen D, Bouillon R, Carmeliet G. 2002. Impaired angiogenesis and endochondral bone formation in mice lacking the vascular endothelial growth factor isoforms VEGF164 and VEGF188. Mech Dev 111:61-73.
30. McGready R, Ashley EA, Moo E, Cho T, Barends M, Hutagalung R, Looareesuwan S, White NJ, Nosten F. 2005. A randomized comparison of artesunate-atovaquone-proguanil versus quinine in treatment for uncomplicated falciparum malaria during pregnancy. J Infect Dis 192:846-853.
31. McGready R, Brockman A, Cho T, Cho D, van Vugt M, Luxemburger C, Chongsuphajaisiddhi T, White NJ, Nosten F. 2000. Randomized comparison of mefloquine-artesunate versus quinine in the treatment of multidrug-resistant falciparum malaria in pregnancy. Trans R Soc Trop Med Hyg 94:689-693.
32. McGready R, Cho T, Cho JJ, Simpson JA, Luxemburger C, Dubowitz L, Looareesuwan S, White NJ, Nosten F. 1998. Artemisinin derivatives in the treatment of falciparum malaria in pregnancy. Trans R Soc Trop Med Hyg 92:430-433.
33. McGready R, Cho T, Keo NK, Thwai KL, Villegas L, Looareesuwan S, White NJ, Nosten F. 2001a. Artemisinin antimalarials in pregnancy: a prospective treatment study of 539 episodes of multidrug-resistant Plasmodium falciparum. Clin Infect Dis 33:2009-2016.
34. McGready R, Cho T, Samuel, Villegas L, Brockman A, van Vugt M, Looareesuwan S, White NJ, Nosten F. 2001b. Randomized comparison of quinine-clindamycln versus artesunate in the treatment of falciparum malaria in pregnancy. Trans R Soc Trop Med Hyg 95:651-656.
35. McGready R and Nosten F. 1999. The Thai-Burmese border: drug studies of Plasmodium falciparum in pregnancy. Ann Trop Med Parasitol 93(Suppl 1):S19-S23.
36. Medvinsky A, Dzierzak E. 1996. Definitive hematopoiesis is autonomously initiated by the AGM region. Cell 86:897-906.
37. Medvinsky AL, Samoylina NL, Muller AM, Dzierzak EA. 1993. An early pre-liver intraembryonic source of CFU-S in the developing mouse. Nature 364:64-67.
38. Moore KL, Persaud TVN. 2003. The developing human: clinically oriented embryology. 7th Ed. Philadelphia: Saunders.
39. Palis J, Yoder MC. 2001. Yolk-sac hematopoiesis: the first blood cells of mouse and man. Exp Hematol 29:927-936.
40. Sachs J, Malaney P. 2002. The economic and social burden of malaria. Nature 415:680-685.
41. SAS Institute. 1990. SAS/STAT User's Guide. 4th Edition. Cary, NC: SAS Institute, Inc.
42. SAS Institute. 1997. SAS/STAT Software: Changes and Enhancements through Release 6.12. Cary, NC: SAS Institute, Inc.
43. Satterthwaite FW. 1946. An approximate distribution of estimates of variance components. Biometrics 2:110-114.
44. Si Y, Zeng J, Johnson T, Xie L, Weina P, Milhous W, Li Q. 2004. Evaluation of the embryonic toxicity of artesunate in rats. Am J Trop Med Hyg 71:260.
45. Snow RW, Guerra CA, Noor AM, Myint HY, Hay SI. 2005. The global distribution of clinical episodes of Plasmodium falciparum malaria. Nature 434:214-217.
46. Solomon HM, Wier PJ, Fish CJ, Hart TK, Johnson CM, Posobiec LM, Gowan CC, Maleeff BE, Kerns WD. 1997. Spontaneous and induced alterations in the cardiac membranous ventricular septum of fetal, weanling, and adult rats. Teratology 55:185-194.
47. Staples RE. 1974. Detection of visceral alterations in mammalian fetuses. Teratology 9:A37.
48. Tavassoli M. 1991. Embryonic and fetal hemopoiesis: an overview. Blood Cells 17:269-281.
49. Wendler CC, Amatya S, McClaskey C, Ghatpande S, Fredholm BB, Rivkees SA. 2007. A1 adenosine receptors play an essential role in protecting the embryo against hypoxia. Proc Natl Acad Sci USA 104:9697-9702.
50. White NJ. 1994. Clinical pharmacokinetics and pharmacodynamics of artemisinin and derivatives. Trans R Soc Trop Med Hyg 88(Suppl 1):S41-S43.
51. White TEK, Bushdid PB, Ritter S, Laffan SB, Clark RL. 2006. Artesunate-induced depletion of embryonic erythroblasts precedes embryo lethality and teratogenicity in vivo. Birth Defects Res B Dev Reprod Toxicol 77:413-429.
52. White TEK, Lordi AW, Bushdid PB, Cox EM, Floyd LE, Fishman CE, Solon EG, Clark RL. 2007. Autoradiography reveals specific labeling of embryonic and fetal red blood cells by the anti-malarial, artesunate. Birth Defects Res A Clin Mol Teratol 79:362.
53. Xu JH, Zhang YP. 1996. [Contragestational effects of dihydroartemisinin and artesunate] (Chinese). Acta Pharmacol Sin 31:657-666.
54. Yoder MC, Hiatt K, Mukherjee P. 1997. In vivo repopulating hematopoietic stem cells are present in the murine yolk sac at day 9.0 postcoitus. Proc Natl Acad Sci USA 94:6776-6780.
55. Zhang SQ, Hai TN, Ilett KF, Huong DX, Davis TM, Ashton M. 2001. Multiple dose study of interactions between artesunate and artemisinin in healthy volunteers. Br J Clin Pharmacol 52:377-385.