Can amodiaquine be used safely during pregnancy?

Thomas, F.; Erhart, Annette; D’Alessandro, Umberto

doi:10.1016/s1473-3099(04)00974-0

Cited by 42 publications

(17 citation statements)

References 27 publications

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“…[110]. Given uncertainty about the safety of amodiaquine in pregnancy[48,49], it is unlikely that this combination will enter clinical IPTp trials in the near future. The combination may, however, be a promising candidate for evaluation in clinical trials for IPTi, particularly in West Africa where amodiaquine-SP has shown encouraging results [111-113].…”

Section: Resultsmentioning

confidence: 99%

“…Three IPTp clinical trials are currently underway in Benin, Malawi and Tanzania [44-46] and will evaluate SP vs mefloquine[44]; SP alone vs SP plus artesunate[45]; and SP alone vs SP plus azithromycin[46] respectively. A phase III clinical trial among 900 pregnant women in Ghana concluded that amodiaquine alone or in combination with SP was effective in treating uncomplicated falciparum malaria[47], but concerns about the safety and tolerability of amodiaquine in pregnancy[48,49] and widespread resistance, particularly in East Africa[23], are likely to hinder development of amodiaquine-containing combinations for IPTp.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Intermittent preventive treatment for malaria in pregnancy in Africa: What's new, what's needed?

Vallely

Changalucha

et al. 2007

Malar J

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Falciparum malaria is an important cause of maternal, perinatal and neonatal morbidity in high transmission settings in Sub-Saharan Africa. Intermittent preventive treatment with sulphadoxinepyrimethamine (SP-IPT) has proven efficacious in reducing the burden of pregnancy-associated malaria but increasing levels of parasite resistance mean that the benefits of national SP-IPT programmes may soon be seriously undermined in much of the region. Hence, there is an urgent need to develop alternative drug regimens for IPT in pregnancy. This paper reviews published safety and efficacy data on various antimalarials and proposes several candidate combination regimens for assessment in phase II/III clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Intermittent preventive treatment for malaria in pregnancy in Africa: What's new, what's needed?

Vallely

Changalucha

et al. 2007

Malar J

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“…In Southeast Asia, amodiaquine is no longer effective for falciparum malaria but may be used increasingly if chloroquine resistance in P. vivax spreads (1). According to the World Health Organization, there is no evidence to contraindicate the use of amodiaquine during pregnancy, although data are limited and additional safety data are needed (2,23,25). The pharmacokinetic properties of AQ and DEAQ have been described for children and adults (5,7,13,16,19,21,29) but not for pregnancy.…”

mentioning

confidence: 99%

Pharmacokinetics of Amodiaquine and Desethylamodiaquine in Pregnant and Postpartum Women with Plasmodium vivax Malaria

Rijken

McGready

Jullien

et al. 2011

Antimicrob Agents Chemother

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In order to study the pharmacokinetic properties of amodiaquine and desethylamodiaquine during pregnancy, 24 pregnant women in the second and third trimesters of pregnancy and with Plasmodium vivax malaria were treated with amodiaquine (10 mg/kg of body weight/day) for 3 days. The same women were studied again at 3 months postpartum. Plasma was analyzed for amodiaquine and desethylamodiaquine by use of a liquid chromatography-tandem mass spectrometry method. Individual concentration-time data were evaluated using noncompartmental analysis. There were no clinically relevant differences in the pharmacokinetics of amodiaquine and desethylamodiaquine between pregnant (n ‫؍‬ 24) and postpartum (n ‫؍‬ 18) women. The results suggest that the current amodiaquine dosing regimen is adequate for the treatment of P. vivax infections during pregnancy.Amodiaquine (AQ) is a 4-aminoquinoline with a structure similar to that of chloroquine (CHQ). Both AQ and its principal biologically active metabolite, desethylamodiaquine (DEAQ), have antimalarial properties, but DEAQ is eliminated much more slowly than AQ and is therefore the main agent responsible for treatment efficacy. AQ is generally more effective than CHQ against chloroquine-resistant Plasmodium falciparum and P. vivax infections, and it has been used both as treatment for symptomatic malaria and intermittent preventive treatment (IPT) during pregnancy (3,4,11,12,20,22). In Southeast Asia, amodiaquine is no longer effective for falciparum malaria but may be used increasingly if chloroquine resistance in P. vivax spreads (1). According to the World Health Organization, there is no evidence to contraindicate the use of amodiaquine during pregnancy, although data are limited and additional safety data are needed (2, 23, 25). The pharmacokinetic properties of AQ and DEAQ have been described for children and adults (5,7,13,16,19,21,29) but not for pregnancy. The pharmacokinetic properties of many antimalarials are altered during pregnancy (27). Ideally, drug regimens for pregnant women should be recommended on the basis of pharmacokinetic and pharmacodynamic studies to maximize efficacy (28). We report the pharmacokinetics of AQ and its principal biologically active metabolite, DEAQ, in the treatment of P. vivax infections in 24 pregnant women. The pharmacokinetic parameters during 42 days posttreatment are compared with those measured in the same women 3 months after delivery. MATERIALS AND METHODSAntenatal clinics. The study was carried out in two antenatal clinics of the Shoklo Malaria Research Unit (SMRU). These clinics are located on the northwestern border of Thailand, an area of malaria endemicity where transmission is low and seasonal for P. falciparum and P. vivax. The majority of the people in this region belong to the Karen ethnic group. All women have a dating ultrasound scan at their first antenatal clinic attendance (18) and are invited to attend weekly consultations providing early detection and treatment of all malaria episodes (14). Women routinely receive fe...

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“…This is used as traditional herbal preparation in the treatment of malaria 8. The report that lethal agranulocytosis and severe hepatic impairment is associated with the use of amodiaquine as a chemoprophylactic agent9 and the fact that the safety of artemisinins still remains a questionable in pregnancy due to insufficient data, forms the rationale for this study.…”

Section: Introductionmentioning

confidence: 99%

Comparative analysis of the safety and tolerability of fixed-dose artesunate/amodiaquine versus artemether/lumefantrine combinations for uncomplicated <em>falciparum</em> malaria in pregnancy: a randomized open label study

Iribhogbe¹,

Emmanuel²,

Odianosen³

2017

CPAA

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A comparative clinical study was conducted to evaluate the safety and tolerability of two commonly used fixed dose artemisinin-based combinations for the treatment of uncomplicated Plasmodium falciparum malaria in the second and third trimester of pregnancy. To achieve this, a total of 155 participants were recruited for the study. Eighty of these were drawn from pregnant women who came for routine antenatal care while 40 nonpregnant participants were recruited from apparently healthy females in the community. Eighty pregnant participants with uncomplicated P. falciparum malaria were randomized into artesunate/amodiaquine (AA) and artemether/lumefantrine (AL) treatment arms while 40 nonpregnant and 35 nonmalarious pregnant women were used as control. The interventional groups received standard fixed dose combinations of AA (100/270 mg) daily or AL (20/120 mg) twice daily for 3 days. Blood samples were collected on day 4 and patients were followed-up closely to ascertain the safety of the drugs. The study showed a significant (p<0.0001) elevation of alkaline phosphatase in the AA and AL group compared to the nonpregnant control and a significant (p<0.05) elevation of alanine transaminase and aspartate transaminase level in the AL combination group when compared with the AA group. The elevated hepatic enzymes were within the normal range for pregnancy and were not clinically significant. Adverse event rate was higher in the AA group (n=28 [70%]) when compared to the AL group (n=4 [10%]) although the drugs were well-tolerated in both treatment arms. In conclusion, the use of these combinations is safe in the second and third trimester of pregnancy. However, we recommend active pharmacovigilance and spontaneous drug reporting of the agents in order to continuously monitor safety in the vastly heterogeneous population.

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Can amodiaquine be used safely during pregnancy?

Cited by 42 publications

References 27 publications

Intermittent preventive treatment for malaria in pregnancy in Africa: What's new, what's needed?

Intermittent preventive treatment for malaria in pregnancy in Africa: What's new, what's needed?

Pharmacokinetics of Amodiaquine and Desethylamodiaquine in Pregnant and Postpartum Women with Plasmodium vivax Malaria

Comparative analysis of the safety and tolerability of fixed-dose artesunate/amodiaquine versus artemether/lumefantrine combinations for uncomplicated <em>falciparum</em> malaria in pregnancy: a randomized open label study

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