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Table 1 Studies which evaluated the safety of mefloquine for treatment of malaria in pregnant women

From: Mefloquine safety and tolerability in pregnancy: a systematic literature review

Reference Study year and location Study design Study women MQ safety on pregnancy outcomes MQ tolerability Comments
Harinasuta et al. 1990 [45] Thailand Clinical trial which compared MQ to QN for the treatment of multi-resistant falciparum malaria N = 85 women (all trimesters) treated with MQ vs N = 72 treated with QN No differences in stillbirth rates between groups All mild and transient adverse events. Small sample size
Limited information on procedures and results available
Okeyeh et al. 1996 [47] Nigeria Non comparative MQ treatment study in pregnant women (12.5 mg/kg) N = 33 women in 2nd and 3rd trimester No stillbirths and congenital malformations reported Minimal side effects Small sample size
Low dose of MQ used
Sowunmi et al. 1998 [49] Nigeria Open label trial which compared artemether to artemether + MQ in the treatment of uncomplicated malaria N = 45 women in 2nd and 3rd trimesters No abortion, stillbirth or congenital anomalies were observed Minimal adverse events reported in the artemether – MQ group (dizziness and abdominal pain) in 2/45 patients Small sample size
n = 23 artemether Open label trial
n = 22 artemether + MQ
McGready et al. 1998 [43] 1991-96 Non- randomized comparative MQ treatment study, cohort series N = 372 Similar rates of congenital anomalies and stillbirths among groups The most common adverse effects following MQ were dizziness (36%) and anorexia (23%) Open label cohort series Groups not well matched
Thailand n = 194 treated with MQ (in 2nd and 3rd trimesters)
n = 93 treated with QN
n = 85 MQ + QN
Nosten et al. 1999 [44] 1991-94 Retrospective analysis of the pregnancy outcomes of women exposed to MQ compared to those not exposed (based on ANC registries and self-reported information from interviews) N = 208 pregnancies exposed to MQ (mainly 2nd and 3rd trimesters) vs Increased risk of reported stillbirths in women exposed to MQ: No data available Analysis with several limitations
Thailand N = 656 exposed to QN vs (9/208) 4.5% (MQ group) vs 1) Four women out of the nine with a stillbirth had been exposed to other anti-malarials;
N = 909 exposed to other anti-malarials vs (10/656) 1.6% (QN group) vs
N = 2,470 not exposed to anti-malarials (12/909) 1.4% (other anti-malarials) vs
(40/2470) 1.8% (not exposed) 2) Recall bias possible (results based on self-reported data)
McGready et al. 2000 [40] 1995-97 Open randomized comparison of different malaria treatments in pregnant women in the 2nd and 3rd trimesters N = 108 No differences in the rates of congenital anomalies, stillbirths or birth weight between the treatment groups No serious adverse effects were reported Small sample size
Thailand n = 42 QN 7 days Dizziness was more frequent in the QN group than in the MQ (87 vs 45%) MQ combined with AS
vs Open label
n = 66 MQ (25 mg/kg) + AS 3 days
Bounyasong 2001 [48] Thailand Open randomized comparison of different malaria treatments in pregnant women in the 2nd and 3rd trimesters N = 60 No data available QN group reported more adverse effects than the MQ group (nausea, vomiting, vertigo, tinnitus and hypoglycaemia) Small sample size
n = 29 QN 7 days vs MQ combined with AS
n = 28 AS + MQ Open label
3 Lost to follow-up
Adam et al. 2004 [46] 1998-2001 Prospective study which evaluated the efficacy and safety of MQ in women who presented with malaria after a full course of CQ therapy N = 40 No abortion, stillbirth and congenital anomalies were observed 35% reported nausea and 17.5% itching Small sample size
  Sudan   Pregnant women in the 2nd or 3rd trimester of gestation    Non comparative study