Mefloquine safety and tolerability in pregnancy: A systematic literature review

Malaria Journal

Volumn 13, Issue 1, 2014, Pages

  González, Raquel ^a,b   Hellgren, Urban ^c   Greenwood, Brian ^d   Menéndez, Clara ^a,b  

^a Barcelona Centre for International Health Research CRESIB   (Spain)

^b Ministérioda Saúde   (Mozambique)

^c KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^d LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

Intermittent preventive treatment; Malaria; Mefloquine; Pregnancy; Safety

Indexed keywords

ANTIMALARIAL AGENT; ARTESUNATE; MEFLOQUINE; PLACEBO; PYRIMETHAMINE PLUS SULFADOXINE; QUININE;

ADVERSE OUTCOME; ANOREXIA; ARTICLE; CONGENITAL MALFORMATION; DIZZINESS; DRUG SAFETY; DRUG TOLERABILITY; FETUS RISK; HIGH RISK PREGNANCY; HUMAN; MALARIA CONTROL; MALARIA FALCIPARUM; PREGNANCY; PREGNANCY OUTCOME; PREGNANT WOMAN; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; SECOND TRIMESTER PREGNANCY; STILLBIRTH; SYSTEMATIC REVIEW; THIRD TRIMESTER PREGNANCY; TINNITUS;

ANTIMALARIALS; CHEMOPREVENTION; FEMALE; HUMANS; MALARIA; MEFLOQUINE; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS;

EID: 84895919042     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/1475-2875-13-75     Document Type: Article

References (67)

1. Avoidability of maternal death in Mozambique: audit and retrospective risk assessment in 106 consecutive cases. Granja ACMF, Bergstrom S, Afr J Health Sci 2000 7 83 87 17650030
2. A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic. Menendez C, Bardaji A, Sigauque B, Romagosa C, Sanz S, Serra-Casas E, Macete E, Berenguera A, David C, Dobano C, Naniche D, Mayor A, Ordi J, Mandomando I, Aponte JJ, Mabunda S, Alonso PL, PLoS One 2008 3 1934 10.1371/journal.pone.0001934 18398460
3. An analysis of malaria in pregnancy in Africa. Brabin BJ, Bull World Health Organ 1983 61 1005 1016 6370484
4. Epidemiology and burden of malaria in pregnancy. Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, Brabin B, Newman RD, Lancet Infect Dis 2007 7 93 104 10.1016/S1473-3099(07)70021-X 17251080
5. The effects of malaria chemoprophylaxis given by traditional birth attendantes on the course and outcome of pregnancy. Greenwood BM GA, Snow RW, Byass P, Bennett S, Hatib N'Jie AB, Trans R Soc Trop Med Hyg 1989 83 589 594 10.1016/0035-9203(89)90362-3 2617619
6. Impact of malaria during pregnancy on low birth weight in sub-Saharan Africa. Guyatt HL, Snow RW, Clin Microbiol Rev 2004 17 760 769 table of contents 10.1128/CMR.17.4.760-769.2004 15489346
7. Development of cellular immune responses to Plasmodium falciparum blood stage antigens from birth to 36 months of age in Cameroon. Le Hesran JY, Fievet N, Thioulouse J, Personne P, Maubert B, M'Bidias S, Etye'ale D, Cot M, Deloron P, Acta Trop 2006 98 261 269 10.1016/j.actatropica.2006.05.010 16820138
8. Reducing the burden of malaria in pregnancy by preventive strategies. Menendez C, D'Alessandro U, ter Kuile FO, Lancet Infect Dis 2007 7 126 135 10.1016/S1473-3099(07)70024-5 17251083
9. Congenital malaria: the least known consequence of malaria in pregnancy. Menendez C, Mayor A, Semin Fetal Neonatal Med 2007 12 207 213 10.1016/j.siny.2007.01.018 17483042
10. The impact of placental malaria on gestational age and birth weight. Menendez C, Ordi J, Ismail MR, Ventura PJ, Aponte JJ, Kahigwa E, Font F, Alonso PL, J Infect Dis 2000 181 1740 1745 10.1086/315449 10823776
11. Placental malaria increases malaria risk in the first 30 months of life. Schwarz NG, Adegnika AA, Breitling LP, Gabor J, Agnandji ST, Newman RD, Lell B, Issifou S, Yazdanbakhsh M, Luty AJ, Kremsner PG, Grobusch MP, Clin Infect Dis 2008 47 1017 1025 10.1086/591968 18781874
12. Malaria as a cause of severe anaemia in pregnancy. DE Shulman CE, Bulmer JN, Lancet 2002 360 494
13. The burden of malaria in pregnancy in malaria-endemic areas. Steketee RW, Nahlen BL, Parise ME, Menendez C, Am J Trop Med Hyg 2001 64 28 35
14. The effect of malaria and malaria prevention in pregnancy on offspring birthweight, prematurity, and intrauterine growth retardation in rural Malawi. Steketee RW, Wirima JJ, Hightower AW, Slutsker L, Heymann DL, Breman JG, Am J Trop Med Hyg 1996 55 33 41 8702035
15. The contribution of malaria in pregnancy to perinatal mortality. van Geertruyden JP, Thomas F, Erhart A, D'Alessandro U, Am J Trop Med Hyg 2004 71 35 40 15331817
16. WHO, A strategic framework for malaria prevention and control during pregnancy in the African region Geneva: World Health Organization 2004 AFR/MAL/04/01
17. WHO, Intermittent Preventive Treatment of malaria in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP). Updated WHO Policy Recommendation Geneva: World Health Organization 2012 http://www.who.int/malaria/iptp-sp-updated- policy-recommendation-en-102012.pdf
18. Temporal trends of sulphadoxine-pyrimethamine (SP) drug-resistance molecular markers in Plasmodium falciparum parasites from pregnant women in western Kenya. Iriemenam NC, Shah M, Gatei W, van Eijk AM, Ayisi J, Kariuki S, Vanden Eng J, Owino SO, Lal AA, Omosun YO, Otieno K, Desai M, Ter Kuile FO, Nahlen B, Moore J, Hamel MJ, Ouma P, Slutsker L, Shi YP, Malar J 2012 11 134 10.1186/1475-2875-11-134 22540158
19. HIV and placental infection modulate the appearance of drug-resistant Plasmodium falciparum in pregnant women who receive intermittent preventive treatment. Menendez C, Serra-Casas E, Scahill MD, Sanz S, Nhabomba A, Bardaji A, Sigauque B, Cistero P, Mandomando I, Dobano C, Alonso PL, Mayor A, Clin Infect Dis 2011 52 41 48 10.1093/cid/ciq049 21148518
20. Rapid increase in the prevalence of sulfadoxine-pyrimethamine resistance among Plasmodium falciparum isolated from pregnant women in Ghana. Mockenhaupt FP, Bedu-Addo G, Eggelte TA, Hommerich L, Holmberg V, von Oertzen C, Bienzle U, J Infect Dis 2008 198 1545 1549 10.1086/592455 18834303
21. Adaptive evolution and fixation of drug-resistant Plasmodium falciparum genotypes in pregnancy-associated malaria: 9-year results from the QuEERPAM study. Taylor SM, Antonia A, Feng G, Mwapasa V, Chaluluka E, Molyneux M, ter Kuile FO, Rogerson SJ, Meshnick SR, Infect Genet Evol 2012 12 282 290 10.1016/j.meegid.2011.11.006 22119749
22. Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine- pyrimethamine with mefloquine. Briand V, Bottero J, Noel H, Masse V, Cordel H, Guerra J, Kossou H, Fayomi B, Ayemonna P, Fievet N, Massougbodji A, Cot M, J Infect Dis 2009 200 991 1001 10.1086/605474 19656069
23. Mefloquine pharmacokinetics in pregnant women with acute falciparum malaria. Na Bangchang K, Davis TM, Looareesuwan S, White NJ, Bunnag D, Karbwang J, Trans R Soc Trop Med Hyg 1994 88 321 323 10.1016/0035-9203(94)90101-5 7974678
24. Mefloquine antimalarial prophylaxis in pregnancy: dose finding and pharmacokinetic study. Nosten F, Karbwang J, White NJ, Honeymoon N, Bangchang K, Bunnag D, Harinasuta T, Br J Clin Pharmacol 1990 30 79 85 10.1111/j.1365-2125. 1990.tb03746.x 2390434
25. Antimalarial drugs and pregnancy: safety, pharmacokinetics, and pharmacovigilance. Ward SA, Sevene EJ, Hastings IM, Nosten F, McGready R, Lancet Infect Dis 2007 7 136 144 10.1016/S1473-3099(07)70025-7 17251084
26. The position of mefloquine as a 21st century malaria chemoprophylaxis. Schlagenhauf P, Adamcova M, Regep L, Schaerer MT, Rhein HG, Malar J 2010 9 357 10.1186/1475-2875-9-357 21143906
27. Mefloquine. Centre de Référence sur les Agents Tératogènes, http://www.lecrat.org/, [accessed February 2014]
28. New recommendations for mefloquine use in pregnancy. FDA, http://www.cdc.gov/malaria/new-info/2011/mefloquine-pregnancy.html, [accessed August 2013]
29. Current knowledge and challenges of antimalarial drugs for treatment and prevention in pregnancy. Sevene E, Gonzalez R, Menendez C, Expert Opin Pharmacother 2010 11 1277 1293 10.1517/14656561003733599 20408744
30. Mefloquine compared with other malaria chemoprophylactic regimens in tourists visiting east Africa. Steffen R, Fuchs E, Schildknecht J, Naef U, Funk M, Schlagenhauf P, Phillips-Howard P, Nevill C, Sturchler D, Lancet 1993 341 1299 1303 10.1016/0140-6736(93)90814-W 8098447
31. Low body mass index is associated with an increased risk of neuropsychiatric adverse events and concentration impairment in women on mefloquine. van Riemsdijk MM, Sturkenboom MC, Ditters JM, Tulen JH, Ligthelm RJ, Overbosch D, Stricker BH, Br J Clin Pharmacol 2004 57 506 512 10.1046/j.1365-2125.2003.02035.x 15025750
32. High-dose mefloquine in the treatment of multidrug-resistant falciparum malaria. ter Kuile FO, Nosten F, Thieren M, Luxemburger C, Edstein MD, Chongsuphajaisiddhi T, Phaipun L, Webster HK, White NJ, J Infect Dis 1992 166 1393 1400 10.1093/infdis/166.6.1393 1431257
33. FDA Drug Safety Communication, FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve effects http://www.fda.gov/Drugs/DrugSafety/ucm362227.htm. 2013, [accessed July 2013]
34. Limitations of postmarketing surveillance in the analysis of risk of pregnancy loss associated with maternal mefloquine exposure. Nevin RL, Clin Infect Dis 2012 55 1167 1168 author reply 1168-1169 10.1093/cid/cis601 22761410
35. Clinical Trials data base. U.S. National Institutes of Health, http://clinicaltrials.gov/, [accessed February 2014]
36. Successful treatment of falciparum malaria in pregnancy with mefloquine. Collignon P, Hehir J, Mitchell D, Lancet 1989 1 967
37. The present status of malaria chemotherapy: mefloquine, a novel antimalarial. Sweeney TR, Med Res Rev 1981 1 281 301 10.1002/med.2610010304 7050565
38. Changes in the treatment responses to artesunate-mefloquine on the northwestern border of Thailand during 13 years of continuous deployment. Carrara VI, Zwang J, Ashley EA, Price RN, Stepniewska K, Barends M, Brockman A, Anderson T, McGready R, Phaiphun L, Proux S, van Vugt M, Hutagalung R, Lwin KM, Phyo AP, Preechapornkul P, Imwong M, Pukrittayakamee S, Singhasivanon P, White NJ, Nosten F, PLoS One 2009 4 4551 10.1371/journal.pone.0004551 19234601
39. Effects of artesunate-mefloquine combination on incidence of Plasmodium falciparum malaria and mefloquine resistance in western Thailand: a prospective study. Nosten F, van Vugt M, Price R, Luxemburger C, Thway KL, Brockman A, McGready R, ter Kuile F, Looareesuwan S, White NJ, Lancet 2000 356 297 302 10.1016/S0140-6736(00)02505-8 11071185
40. Randomized comparison of mefloquine-artesunate versus quinine in the treatment of multidrug-resistant falciparum malaria in pregnancy. McGready R, Brockman A, Cho T, Cho D, van Vugt M, Luxemburger C, Chongsuphajaisiddhi T, White NJ, Nosten F, Trans R Soc Trop Med Hyg 2000 94 689 693 10.1016/S0035-9203(00)90235-9 11198658
41. Drugs for treating uncomplicated malaria in pregnant women. Orton LC, Omari AA, Cochr Database Syst Rev (Online) 2008 4 D004912
42. Safe and efficacious artemisinin-based combination treatments for african pregnant women with malaria (PREGACT). Clinicaltrials.gov, http:// clinicaltrials.gov/ct2/show/NCT00852423 2010-14
43. Quinine and mefloquine in the treatment of multidrug-resistan Plasmodium falciparum malaria in pregnancy. McGready R, Cho T, Hkirijaroen L, Simpson J, Chongsuphajaisiddhi T, White NJ, Nosten F, Ann Trop Med Parasit 1998 92 643 653 10.1080/00034989859104 9924543
44. The effects of mefloquine treatment in pregnancy. Nosten F, Vincenti M, Simpson J, Yei P, Thwai KL, de Vries A, Chongsuphajaisiddhi T, White NJ, Clin Infect Dis 1999 28 808 815 10.1086/515183 10825043
45. A clinical trial of mefloquine on multi-resistant falciparum malaria in pregnant women in Thailand. Harinasuta T, Kietinun S, Somlaw S, Bunnag D, Sheth U, Wernsdorfer W, Bull Soc Fr Parasitol 1990 429
46. Mefloquine in the treatment of falciparum malaria during pregnancy in Eastern Sudan. Adam I, Ali DA, Alwaseila A, Kheir MM, Elbashir MI, Saudi Med J 2004 25 1400 1402 15494810
47. Malaria in pregnancy: efficacy of a low dose of mefloquine in an area holoendemic for multi-drug resistant Plasmodium falciparum. Okeyeh JN, Lege-Oguntoye L, Emembolu JO, Agbo M, Ann Trop Med Parasit 1996 90 265 268 8758140
48. Randomized trial of artesunate and mefloquine in comparison with quinine sulfate to treat P. falciparum malaria pregnant women. Bounyasong S, J Med Assoc Thai 2001 84 1289 1299 11800303
49. Randomised trial of artemether versus artemether and mefloquine for the treatment of chloroquine/sufadoxine-pyrimethamine-resistant falciparum malaria during pregnancy. Sowunmi A, Oduola AM, Ogundahunsi OA, Fehintola FA, Ilesanmi OA, Akinyinka OO, Arowojolu AO, J Obstet Gynaecol 1998 18 322 327 10.1080/01443619867038 15512100
50. Mefloquine prophylaxis prevents malaria during pregnancy: a double-blind, placebo-controlled study. Nosten F, ter Kuile F, Maelankiri L, Chongsuphajaisiddhi T, Nopdonrattakoon L, Tangkitchot S, Boudreau E, Bunnag D, White NJ, J Infect Dis 1994 169 595 603 10.1093/infdis/169.3.595 8158032
51. Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine. Steketee RW, Wirima JJ, Slutsker L, Khoromana CO, Heymann DL, Breman JG, Am J Trop Med Hyg 1996 55 50 56 8702037
52. Malaria parasite infection during pregnancy and at delivery in mother, placenta, and newborn: efficacy of chloroquine and mefloquine in rural Malawi. Steketee RW, Wirima JJ, Slutsker L, Roberts JM, Khoromana CO, Heymann DL, Breman JG, Am J Trop Med Hyg 1996 55 24 32
53. The effects of inadvertent exposure of mefloquine chemoprophylaxis on pregnancy outcomes and infants of US Army servicewomen. Smoak BL, Writer JV, Keep LW, Cowan J, Chantelois JL, J Infect Dis 1997 176 831 833 10.1086/517315 9291347
54. Post-marketing surveillance of prophylactic mefloquine (Lariam) use in pregnancy. Vanhauwere B, Maradit H, Kerr L, Am J Trop Med Hyg 1998 58 17 21 9452285
55. Safety of mefloquine and other antimalarial agents in the first trimester of pregnancy. Phillips-Howard PA, Steffen R, Kerr L, Vanhauwere B, Schildknecht J, Fuchs E, Edwards R, J Travel Med 1998 5 121 126 10.1111/j.1708-8305.1998. tb00484.x 9772329
56. Tolerability of mefloquine intermittent preventive treatment for malaria in HIV-infected pregnant women in Benin. Denoeud-Ndam L, Clement MC, Briand V, Akakpo J, Agossou VK, Atadokpede F, Dossou-Gbete L, Komongui DG, Afangnihoun A, Girard PM, Zannou DM, Cot M, J Acquir Immune Defic Syndrom 2012 61 64 72 10.1097/QAI.0b013e3182615a58
57. Pregnancy and fetal outcomes after exposure to mefloquine in the pre- and periconception period and during pregnancy. Schlagenhauf P, Blumentals WA, Suter P, Regep L, Vital-Durand G, Schaerer MT, Boutros MS, Rhein HG, Adamcova M, Clin Infect Dis 2012 54 124 e131 10.1093/cid/cis215 22495078
58. Mefloquine gap junction blockade and risk of pregnancy loss. Nevin RL, Biol Reprod 2012 87 65 10.1095/biolreprod.112.099614 22837476
59. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, Ann Int Med 2004 141 781 788 10.7326/0003-4819-141-10- 200411160-00009 15545678
60. Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin A, Kuhlmann J, Wensing G, Int J Clin Pharmacol Ther 2005 43 217 226 10.5414/CPP43217 15906587
61. Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille M, Deigat N, Janin A, Kirkesseli S, Durand DV, Eur J Clin Pharmacol 1998 54 13 20 10.1007/s002280050413 9591924
62. Clinical malaria in African pregnant women. Bardaji A, Sigauque B, Bruni L, Romagosa C, Sanz S, Mabunda S, Mandomando I, Aponte J, Sevene E, Alonso PL, Menendez C, Malar J 2008 7 27 10.1186/1475-2875-7-27 18234078
63. Safety, efficacy and determinants of effectiveness of antimalarial drugs during pregnancy: implications for prevention programmes in Plasmodium falciparum-endemic sub-Saharan Africa. Newman RD, Parise ME, Slutsker L, Nahlen B, Steketee RW, Trop Med Int Health 2003 8 488 506 10.1046/j.1365-3156.2003. 01066.x 12791054
64. Antimalarial Drugs in Pregnancy: A Review. Nosten FMR, d'Alessandro U, Bonell A, Verhoeff F, Menendez C, Mutabingwa T, Brabin B, Curr Drug Saf 2006 1 1 15 10.2174/157488606775252584 18690910
65. Evaluation of alternative antimalarial drugs for malaria in pregnancy (MiPPAD). Clinicaltrials.gov, http://clinicaltrials.gov/show/NCT00811421 2009-13
66. Cotrimoxazole prophylaxis versus mefloquine intermittent preventive treatment to prevent malaria in HIV-infected pregnant women: two randomized controlled trials. Denoeud-Ndam L, Zannou DM, Fourcade C, Taron-Brocard C, Porcher R, Atadokpede F, Komongui DG, Dossou-Gbete L, Afangnihoun A, Ndam NT, Girard PM, Cot M, J Acquir Immune Defic Syndrom 2014 65 198 206 10.1097/QAI.0000000000000058
67. HIV and malaria interactions: where do we stand? Gonzalez R, Ataide R, Naniche D, Menendez C, Mayor A, Expert Rev Anti Infect Ther 2012 10 153 165 10.1586/eri.11.167 22339190