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 |