Antimalarial drugs and pregnancy: safety, pharmacokinetics, and pharmacovigilance

Lancet Infectious Diseases

Volumn 7, Issue 2, 2007, Pages 136-144

  Ward, Stephen A ^a   Sevene, Esperanca JP ^b   Hastings, Ian M ^a   Nosten, François ^c,d,e   McGready, Rose ^c,d,e  

^a LIVERPOOL SCHOOL OF TROPICAL MEDICINE   (United Kingdom)

^b University of Maputo   (Mozambique)

^c SHOKLO MALARIA RESEARCH UNIT   (Thailand)

^d MAHIDOL UNIVERSITY   (Thailand)

^e JOHN RADCLIFFE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

4 AMINOQUINOLINE DERIVATIVE; AMODIAQUINE; ANTIBIOTIC AGENT; ANTIMALARIAL AGENT; ARTEMETHER; ARTEMETHER PLUS BENFLUMETOL; ARTEMISININ; ARTEMISININ DERIVATIVE; ARTESUNATE; ATOVAQUONE PLUS PROGUANIL; AZITHROMYCIN; BENFLUMETOL; CHLOROQUINE; CHLORPROGUANIL; CHLORPROGUANIL PLUS DAPSONE; CLINDAMYCIN; DAPSONE; DIHYDROARTEMISININ; FANSIDAR; FOLIC ACID ANTAGONIST; GENTAMICIN; HALOFANTRINE; MEFLOQUINE; PIPERAQUINE; QUININE; QUINOLINE DERIVATIVE; UNINDEXED DRUG;

AREA UNDER THE CURVE; BLOOD TOXICITY; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DOSE REDUCTION; DRUG METABOLISM; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEMALE; HEMOLYTIC ANEMIA; HUMAN; LIVER TOXICITY; LOADING DRUG DOSE; MALARIA; OTOTOXICITY; PREGNANCY; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; RETINA DISEASE; REVIEW; SIDE EFFECT; SKIN TOXICITY; STILLBIRTH;

ANIMALS; ANTIMALARIALS; FEMALE; HUMANS; MALARIA, FALCIPARUM; MICE; PREGNANCY; PREGNANCY COMPLICATIONS, PARASITIC; RATS;

EID: 33846314664     PISSN: 14733099     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1473-3099(07)70025-7     Document Type: Review

References (70)

1. Tagbor H., Bruce J., Browne E., Randal A., Greenwood B., and Chandramohan D. Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial. Lancet 368 (2006) 1349-1356
2. Okoyeh J., Lege-Oguntoye L., Emembolu J., Sarki U., and Slotboom A. Sensitivity of Plasmodium falciparum to chloroquine in pregnant women in Zaria, northern Nigeria. Trop Geogr Med 45 (1993) 56-58
3. Rukaria-Kaumbutho R., Ojwang S., and Oyieke J. Resistance to chloroquine therapy in pregnant women with malaria parasitemia. Int J Gynaecol Obstet 53 (1996) 235-241
4. Mutabingwa T., Malle L., and Mtui S. Chloroquine therapy still useful in the management of malaria during pregnancy in Muheza, Tanzania. Trop Geogr Med 43 (1991) 131-135
5. Nosten F., McGready R., d'Alessandro U., et al. Antimalarial drugs in pregnancy: a review. Curr Drug Saf 1 (2006) 1-12
6. Hart C., and Naunton R. The ototoxicity of chloroquine phosphate. Arch Otolaryngol 80 (1964) 407-412
7. Paufique L., and Magnard P. Retinal degeneration in 2 children following preventive antimalarial treatment of the mother during pregnancy. Bull Soc Ophtalmol Fr 69 (1969) 466-467
8. Parke A. Antimalarial drugs and pregnancy. Am J Med 84 (1988) 30-33
9. Costedoat-Chalumeau N., Amoura Z., Duhaut P., et al. Safety of hydroxychloroquine in pregnant patients with connective tissue diseases: a study of one hundred thirty-three cases compared with a control group. Arthritis Rheum 48 (2003) 3207-3211
10. Okanlawon A., Ejiwunmi A., Dado M., and Ashira O. Chloroquine-induced retardation of foetal lung maturation in rats. Afr J Med Med Sci 22 (1993) 61-67
11. Chatterjee T., Muhkopadhyay A., Khan K., and Giri A. Comparative mutagenic and genotoxic effects of three antimalarial drugs, chloroquine, primaquine and amodiaquine. Mutagenesis 29 (1998) 10-17
12. Munzner R., and Renner H. Mutagenicity testing of quinine with submammalian and mammalian systems. Toxicology 26 (1983) 173-178
13. Savini E., Moulin M., and Herrou M. Experimental study of the effects of quinine on the rat, rabbit and dog fetus. Therapie 26 (1971) 563-574
14. Colley J., Edwards J., Heywood R., and Purser D. Toxicity studies with quinine hydrochloride. Toxicology 54 (1989) 219-226
15. Tanimura T. Effects on macaque embryos of drugs reported or suspected to be teratogenic to humans. Acta Endocrinol Suppl (Copenh) 166 (1972) 293-308
16. Lapointe G., and Nosal G. Saccharin- or quinine-induced changes in the rat pups following prolonged ingestion by the dam. Biol Neonate 36 (1979) 273-276
17. Nosten F., Vincenti M., Simpson J., et al. The effects of mefloquine treatment in pregnancy. Clin Infect Dis 28 (1999) 808-815
18. McGready R., Ashley E., Moo E., et al. A randomized comparison of artesunate-atovaquone-proguanil versus quinine in treatment for uncomplicated falciparum malaria during pregnancy. J Infect Dis 192 (2005) 846-853
19. McGready R., Keo N., Villegas L., White N., Looareesuwan S., and Nosten F. Artesunate-atovaquone-proguanil rescue treatment of multidrug-resistant Plasmodium falciparum malaria in pregnancy: a preliminary report. Trans R Soc Trop Med Hyg 97 (2003) 592-594
20. Schardein J. Drugs as teratogens (1976), CRC Press, Cleveland, OH
21. Tsuda S., Kosaka Y., Matsusaka N., and Sasaki Y. Detection of pyrimethamine-induced DNA damage in mouse embryo and maternal organs by the modified alkaline single cell gel electrophoresis assay. Mutat Res 415 (1998) 69-77
22. Chung M., Han S., and Roh J. Synergistic embryotoxicity of combination pyrimethamine and folic acid in rats. Reprod Toxicol 7 (1993) 463-468
23. Keuter M., van Eijk A., Hoogstrate M., et al. Comparison of chloroquine, pyrimethamine and sulfadoxine, and chlorproguanil and dapsone as treatment for falciparum malaria in pregnant and non-pregnant women, Kakamega District, Kenya. BMJ 301 (1990) 466-470
24. Chen L., Wang M., Sun W., and Liu M. Embryotoxicity and teratogenicity studies on artemether in mice, rats and rabbits. Zhongguo Yao Li Xue Bao 5 (1984) 118-122 (in Chinese).
25. Li Z. Teratogenicity of sodium artesunate. Zhong Yao Tong Bao 13 (1988) 42-44 (in Chinese).
26. Xu J., and Zhang Y. Contragestational effects of dihydroartemisinin and artesunate. Yao Xue Xue Bao 31 (1996) 657-661 (in Chinese).
27. Clark R., White T., Clode S., Gaunt I., Winstanley P., and Ward S. Developmental toxicity of artesunate and an artesunate combination in the rat and rabbit. Birth Defects Res A Clin Mol Teratol 71 (2004) 380-394
28. White T., Clode S., Gaunt I., Ward S., Powell C., and Clark R. Developmental toxicity of artesunate in the rat and rabbit. Birth Defects Res A Clin Mol Teratol 70 (2004) 265
29. WHO. Assessment of the safety of artemisinin compounds in pregnancy. WHO/CDS/MAL/2003.1094. WHO/RBM/TDR/Artemisinin/03.1 (2003), World Health Organization, Geneva
30. Jollie W. Development, morphology, and function of the yolk-sac placenta of laboratory rodents. Teratology 41 (1990) 361-381
31. Kawamura S., Yoshioka T., Kato T., Matsuo M., and Yasuda M. Histological changes in rat embryonic blood cells as a possible mechanism for ventricular septal defects produced by an N-phenylimide herbicide. Teratology 54 (1996) 237-244
32. Longo M., Zanoncelli S., Manera D., et al. Effects of the antimalarial drug dihydroartemisinin (DHA) on rat embryos in vitro. Reprod Toxicol 21 (2006) 83-93
33. Clark R., Kumemura M., Makori N., et al. Artesunate: embryolethal effects in cynomolgus monkeys. Am J Trop Med Hyg 75 (2006) 54
34. Brabin B., Maxwell S., Chimsuku L., et al. A study of the consequences of malarial infection in pregnant women and their infants. Parasitologie 35 suppl (1993) 9-11
35. Dondorp A., Nosten F., Stepniewska K., Day N., and White N. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet 366 (2005) 717-725
36. Angus B., Thaiaporn I., Chanthapadith K., Suputtamongkol Y., and White N. Oral artesunate dose-response relationship in acute falciparum malaria. Antimicrob Agents Chemother 46 (2002) 778-782
37. McGready R., Stepniewska K., Ward S., et al. Pharmacokinetics of dihydroartemisinin following oral artesunate treatment of pregnant women with acute uncomplicated falciparum malaria. Eur J Clin Pharmacol 62 (2006) 367-371
38. Newton P., Suputtamongkol Y., Teja-Isavadharm P., et al. Antimalarial bioavailability and disposition of artesunate in acute falciparum malaria. Antimicrob Agents Chemother 44 (2000) 972-977
39. Hutagalung R., Paiphun L., Ashley E., et al. A randomized trial of artemether-lumefantrine versus mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand. Malar J 4 (2005) 46
40. van Vugt M., Edstein M., Proux S., et al. Absence of an interaction between artesunate and atovaquone-proguanil. Eur J Clin Pharmacol 55 (1999) 469-474
41. McGready R., Stepniewska K., Lindegardh N., et al. The pharmacokinetics of artemether and lumefantrine in pregnant women with uncomplicated falciparum malaria. Eur J Clin Pharmacol 62 (2006) 1021-1031
42. Akintonwa A., Gbajumo S., and Mabadeje A. Placental and milk transfer of chloroquine in humans. Ther Drug Monit 10 (1988) 147-149
43. Massele A., Kilewo C., Aden Abdi Y., et al. Chloroquine blood concentrations and malaria prophylaxis in Tanzanian women during the second and third trimesters of pregnancy. Eur J Clin Pharmacol 52 (1997) 299-305
44. Chukwuani M., Bolaji O., Onyeji C., Makinde O., and Ogunbona F. Evidence for increased metabolism of chloroquine during the early third trimester of human pregnancy. Trop Med Int Health 9 (2004) 601-605
45. Fakeye T., Fehintola F., Ademowo O., and Walker O. Therapeutic monitoring of chloroquine in pregnant women with malaria. West Afr J Med 21 (2002) 286-287
46. Nosten F., Karbwang J., White N., et al. Mefloquine antimalarial prophylaxis in pregnancy: dose finding and pharmacokinetic study. Br J Clin Pharmacol 30 (1990) 79-85
47. Na Bangchang K., Davis T., Looareesuwan S., et al. Mefloquine pharmacokinetics in pregnant women with acute falciparum malaria. Trans R Soc Trop Med Hyg 88 (1994) 321-323
48. Phillips R., Looareesuwan S., White N., et al. Hypoglycaemia and antimalarial drugs: quinidine and release of insulin. Br J Clin Pharmacol 21 (1986) 677-683
49. Wangboonskul J., White N., Nosten F., et al. Single dose pharmacokinetics of proguanil and its metabolites in pregnancy. Eur J Clin Pharmacol 44 (1993) 247-251
50. Alloueche A., Bailey W., Barton S., et al. Comparison of chlorproguanil-dapsone with sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in young African children: double-blind randomised controlled trial. Lancet 363 (2004) 1843-1848
51. Brabin B., Eggelte T., Parise M., and Verhoeff F. Dapsone therapy for malaria during pregnancy: maternal and fetal outcomes. Drug Saf 27 (2004) 633-648
52. McGready R., Stepniewska K., Edstein M., et al. The pharmacokinetics of atovaquone and proguanil in pregnant women with acute falciparum malaria. Eur J Clin Pharmacol 59 (2003) 545-552
53. Na-Bangchang K., Manyando C., Ruengweerayut R., et al. The pharmacokinetics and pharmacodynamics of atovaquone and proguanil for the treatment of uncomplicated falciparum malaria in third-trimester pregnant women. Eur J Clin Pharmacol 61 (2005) 573-582
54. McGready R., Cho T., Samuel, et al. Randomized comparison of quinine-clindamycin versus artesunate in the treatment of falciparum malaria in pregnancy. Trans R Soc Trop Med Hyg 95 (2001) 651-656
55. Weinstein A., Gibbs R., and Gallagher M. Placental transfer of clindamycin and gentamicin in term pregnancy. Am J Obstet Gynecol 124 (1976) 688-691
56. Ramsey P., Vaules M., Vasdev G., Andrews W., and Ramin K. Maternal and transplacental pharmacokinetics of azithromycin. Am J Obstet Gynecol 188 (2003) 714-718
57. WHO. The importance of pharmacovigilance: safety monitoring of medicinal products (2002), World Health Organization, Geneva
58. Edwards I. The management of adverse drug reactions: from diagnosis to signals. Adverse Drug Reactions J 1 (2000) 103-105
59. Uppsala Monitoring Centre. WHO programme for international drug monitoring. http://www.who-umc.org (accessed Jan 3, 2007).
60. Sevene E., Lewin S., Mariano A., et al. System and market failures: the unavailability of magnesium sulphate for the treatment of eclampsia and pre-eclampsia in Mozambique and Zimbabwe. BMJ 331 (2005) 765-769
61. Simooya O. The WHO 'Roll Back Malaria Project': planning for adverse event monitoring in Africa. Drug Saf 28 (2005) 277-286
62. Couper M. Pharmacovigilance in public health programmes. Presentation on activities in pharmacovigilance at WHO HQ (2005), World Health Organization, Geneva. http://www.ops.org.bo/medicamentos/essential_medicines/3-quality/pharmacovigilance.ppt (accessed Jan 3, 2007).
63. Taylor W., and White N. Antimalarial drug toxicity: a review. Drug Saf 27 (2004) 25-61
64. Edwards I. Safety monitoring of new anti-malarials in immediate post-marketing phase. Med Trop (Mars) 58 (1998) 93-96
65. WHO. Assessment of the safety of artemisinin compounds in pregnancy (2003), World Health Organization, Geneva
66. Dodoo A., Marfo F., Thompson H., Allotey N., and Bart-Plange C. Effectiveness of a simplified spontaneous reporting form for intensive monitoring of adverse events during intermittent preventive treatment of malaria in pregnant women with sulphadoxine-pyrimethamine. Drug Saf 28 (2005) 958
67. Regional Malaria Control Commission. Malaria control in the Lubombo Spatial Development area. Annual Report 2004. http://www.malaria.org.za/lsdi/progress/LSDI%20Annual%20Report2004.pdf (accessed April 3, 2006).
68. Dodoo A., Gyansa-Lutterodt M., Frempong N., et al. Preliminary safety assessment of sulphadoxine-pyrimethamine during intermittent presumptive treatment of pregnant women in a region with high prevalence of G6PD deficiency. Int J Risk Saf Med 17 (2005) 13-18
69. Beyens M., Guy C., Ratrema M., and Ollagnier M. Prescription of drugs to pregnant women in France: the HIMAGE study. Therapie 58 (2003) 505-511
70. Gomes K., Moron A., Silva R., and Siqueira A. Prevalence of use of medicines during pregnancy and its relationship to maternal factors. Rev Saude Publica 33 (1999) 246-254