Study on the developmental toxicity of combined artesunate and mefloquine antimalarial drugs on rats

Reproductive Toxicology

Volumn 34, Issue 4, 2012, Pages 658-664

  Boareto, Ana Cláudia ^a   Müller, Juliane Centeno ^a   de Araujo, Samanta Luiza ^a   Lourenço, Ana Carolina ^a   Lourenço, Emerson Luiz Botelho ^a   Gomes, Caroline ^a   Minatovicz, Bruna ^a   Lombardi, Natália ^a   Paumgartten, Francisco Roma ^b   Dalsenter, Paulo Roberto ^a  

^a FEDERAL UNIVERSITY OF PARANÁ   (Brazil)

^b INSTITUTO OSWALDO CRUZ   (Brazil)

Author keywords

Antimalarial; Artesunate; Embryolethality; Mefloquine; Reproductive toxicology; Teratology

Indexed keywords

ARTESUNATE; ARTESUNATE PLUS MEFLOQUINE; MEFLOQUINE; SIFAVITOR; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DEVELOPMENTAL TOXICITY; DOSE RESPONSE; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; EMBRYOTOXICITY; FEMALE; INCIDENCE; LETHALITY; MALE; NONHUMAN; PREGNANCY; RAT; REPRODUCTIVE TOXICITY; UTERUS WEIGHT; WEIGHT GAIN;

ABNORMALITIES, DRUG-INDUCED; ANIMALS; ANTIMALARIALS; ARTEMISININS; BONE AND BONES; DRUG COMBINATIONS; DRUG INTERACTIONS; EMBRYONIC DEVELOPMENT; FEMALE; FETAL DEVELOPMENT; MEFLOQUINE; PREGNANCY; RATS; RATS, WISTAR; TERATOGENS; VISCERA;

ARTESUNATE; PLASMODIUM FALCIPARUM; RATTUS;

EID: 84868230682     PISSN: 08906238     EISSN: 18731708     Source Type: Journal    
DOI: 10.1016/j.reprotox.2012.10.004     Document Type: Article

References (43)

1. AlKadi H.O. Antimalarial drug toxicity: a review. Chemotherapy 2007, 53:385-391.
2. Nosten F., White N.J. Artemisinin-based combination treatment of falciparum malaria. American Journal of Tropical Medicine and Hygiene 2007, 77:181-192.
3. Brabin B., Piper C. Anaemia- and malaria-attributable low birthweight in two populations in Papua New Guinea. Annals of Human Biology 1997, 24:547-555.
4. Deen J.L., von Seidlein L. Antimalarial use during pregnancy and its effect on birthweight. Transactions of the Royal Society of Tropical Medicine and Hygiene 2002, 96:573-574.
5. Deen J.L., von Seidlein L., Pinder M., Walraven G.E., Greenwood B.M. The safety of the combination artesunate and pyrimethamine-sulfadoxine given during pregnancy. Transactions of the Royal Society of Tropical Medicine and Hygiene 2001, 95:424-428.
6. Bialek R., Knobloch J. Parasitic infections in pregnancy and congenital protozoan infections. Part I: Protozoan infections. Zeitschrift fur Geburtshilfe und Neonatologie 1999, 203:55-62.
7. Meshnick S.R., Taylor T.E., Kamchonwongpaisan S. Artemisinin and the antimalarial endoperoxides: from herbal remedy to targeted chemotherapy. Microbiological Reviews 1996, 60:301-315.
8. Clark R.L. Embryotoxicity of the artemisinin antimalarials and potential consequences for use in women in the first trimester. Reproductive Toxicology 2009, 28:285-296.
9. Wongsrichanalai C., Meshnick S.R. Declining artesunate-mefloquine efficacy against falciparum malaria on the Cambodia-Thailand border. Emerging Infectious Diseases 2008, 14:716-719.
10. Lim P., Alker A.P., Khim N., Shah N.K., Incardona S., Doung S., et al. Pfmdr1 copy number and arteminisin derivatives combination therapy failure in falciparum malaria in Cambodia. Malaria Journal 2009, 8:11.
11. Rogers W.O., Sem R., Tero T., Chim P., Lim P., Muth S., et al. Failure of artesunate-mefloquine combination therapy for uncomplicated Plasmodium falciparum malaria in southern Cambodia. Malaria Journal 2009, 8:10.
12. Ashley E.A., White N.J. Artemisinin-based combinations. Current Opinion in Investigational Drugs 2005, 18:531-536.
13. WHO World Health Organization guidelines for the treatment of malaria 2006, http://www.who.int/malaria/docs/TreatmentGuidelines2006.pdf.
14. Clark R.L., White T.E., AC S., Gaunt I., Winstanley P., Ward S.A. Developmental toxicity of artesunate and an artesunate combination in the rat and rabbit. Birth Defects Research Part B: Developmental and Reproductive Toxicology 2004, 71:380-394.
15. Clark R.L., Lerman S.A., Cox E.M., Gristwood W.E., White T.E. Developmental toxicity of artesunate in the rat: comparison to other artemisinins, comparison of embryotoxicity and kinetics by oral and intravenous routes, and relationship to maternal reticulocyte count. Birth Defects Research Part B: Developmental and Reproductive Toxicology 2008, 83:397-406.
16. White T.E., Clark R.L. Sensitive periods for developmental toxicity of orally administered artesunate in the rat. Birth Defects Research Part B: Developmental and Reproductive Toxicology 2008, 83:407-417.
17. White T.E., Bushdid P.B., Ritter S., Laffan S.B., Clark R.L. Artesunate-induced depletion of embryonic erythroblasts precedes embryolethality and teratogenicity in vivo. Birth Defects Research Part B: Developmental and Reproductive Toxicology 2006, 77:413-429.
18. Palmer K.J., Holliday S.M., Brogden R.N. Mefloquine. A review of its antimalarial activity, pharmacokinetic properties and therapeutic efficacy. Drugs 1993, 45:430-475.
19. Phillips-Howard P.A., Wood D. The safety of antimalarial drugs in pregnancy. Drug Safety 1996, 14:131-145.
20. Nosten F., Vincenti M., Simpson J., Yei P., Thwai K.L., de Vries A., et al. The effects of mefloquine treatment in pregnancy. Clinical Infectious Diseases 1999, 28:808-815.
21. McGready R., Brockman A., Cho T., Cho D., van Vugt M., Luxemburger C., et al. Randomized comparison of mefloquine-artesunate versus quinine in the treatment of multidrug-resistant falciparum malaria in pregnancy. Transactions of the Royal Society of Tropical Medicine and Hygiene 2000, 94:689-693.
22. WHO Guidelines for the treatment of malaria 2010, World Health Organization;, Geneva. 2nd ed.
23. Nevill A.M. The need to scale for differences in body size and mass: an explanation of Kleiber's 0.75 mass exponent. Journal of Applied Physiology 1994, 77:2870-2873.
24. Makris S.L., Solomon H.M., Clark R., Shiota K., Barbellion S., Buschmann J., et al. Terminology of developmental abnormalities in common laboratory mammals (version 2). Congenit Anom (Kyoto) 2009, 49:123-246.
25. Staples R.E., Haseman J.K. Commentary: selection of appropriate experimental units in teratology. Teratology 1974, 9:259-260.
26. Wilson J.G. Embryological considerations in teratology. Annals of the New York Academy of Sciences 1965, 123:219-227.
27. Staples R.E., Schnell V.L. Refinements in rapid clearing technic in the Koh-Alizarin red S method for fetal bone. Stain Technology 1964, 39:61-63.
28. McGready R., Cho T., Cho J.J., Simpson J.A., Luxemburger C., Dubowitz L., et al. Artemisinin derivatives in the treatment of falciparum malaria in pregnancy. Transactions of the Royal Society of Tropical Medicine and Hygiene 1998, 92:430-433.
29. McGready R., Nosten F. The Thai-Burmese border: drug studies of Plasmodium falciparum in pregnancy. Annals of Tropical Medicine and Parasitology 1999, 93(Suppl. 1):S19-S23.
30. Dellicour S., Hall S., Chandramohan D., Greenwood B. The safety of artemisinins during pregnancy: a pressing question. Malaria Journal 2007, 6:15.
31. Nosten F., Hien T.T., White N.J. Use of artemisinin derivatives for the control of malaria. Medecine Tropicale 1998, 58:45-49.
32. Ward S.A., Sevene E.J., Hastings I.M., Nosten F., McGready R. Antimalarial drugs and pregnancy: safety, pharmacokinetics, and pharmacovigilance. Lancet Infectious Diseases 2007, 7:136-144.
33. Vanhauwere B., Maradit H., Kerr L. Post-marketing surveillance of prophylactic mefloquine (Lariam) use in pregnancy. American Journal of Tropical Medicine and Hygiene 1998, 58:17-21.
34. Nosten F., ter Kuile F., Maelankiri L., Chongsuphajaisiddhi T., Nopdonrattakoon L., Tangkitchot S., et al. Mefloquine prophylaxis prevents malaria during pregnancy: a double-blind, placebo-controlled study. Journal of Infectious Diseases 1994, 169:595-603.
35. Steketee R.W., Wirima J.J., Slutsker L., Khoromana C.O., Heymann D.L., Breman J.G. Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine. American Journal of Tropical Medicine and Hygiene 1996, 55:50-56.
36. Staples R. Detection of visceral alterations in mammalian fetuses. Teratology 1974, 9:37-38.
37. Solomon H.M., Wier P.J., Fish C.J., Hart T.K., Johnson C.M., Posobiec L.M., et al. Spontaneous and induced alterations in the cardiac membranous ventricular septum of fetal, weanling, and adult rats. Teratology 1997, 55:185-194.
38. Burk O., Arnold K.A., Nussler A.K., Schaeffeler E., Efimova E., Avery B.A., et al. Antimalarial artemisinin drugs induce cytochrome P450 and MDR1 expression by activation of xenosensors pregnane X receptor and constitutive androstane receptor. Molecular Pharmacology 2005, 67:1954-1965.
39. Li X.Q., Bjorkman A., Andersson T.B., Gustafsson L.L., Masimirembwa C.M. Identification of human cytochrome P(450)s that metabolise anti-parasitic drugs and predictions of in vivo drug hepatic clearance from in vitro data. European Journal of Clinical Pharmacology 2003, 59:429-442.
40. Ilett K.F., Ethell B.T., Maggs J.L., Davis T.M., Batty K.T., Burchell B., et al. Glucuronidation of dihydroartemisinin in vivo and by human liver microsomes and expressed UDP-glucuronosyltransferases. Drug Metabolism and Disposition: The Biological Fate of Chemicals 2002, 30:1005-1012.
41. Davis T.M., England M., Dunlop A.M., Page-Sharp M., Cambon N., Keller T.G., et al. Assessment of the effect of mefloquine on artesunate pharmacokinetics in healthy male volunteers. Antimicrobial Agents and Chemotherapy 2007, 51:1099-1101.
42. Longo M., Zanoncelli S., Manera D., Brughera M., Colombo P., Lansen J., et al. Effects of the antimalarial drug dihydroartemisinin (DHA) on rat embryos in vitro. Reproductive Toxicology 2006, 21:83-93.
43. Longo M., Zanoncelli S., Torre P.D., Riflettuto M., Cocco F., Pesenti M., et al. In vivo and in vitro investigations of the effects of the antimalarial drug dihydroartemisinin (DHA) on rat embryos. Reproductive Toxicology 2006, 22:797-810.