Atovaquone:proguanil (Malarone®) is a fixed-dose combination product used in malaria chemoprophylaxis and in the treatment of falciparum malaria. A separate UKTIS monograph regarding the use of proguanil-only preparations in pregnancy is also available.
Travel to areas where malaria is endemic should be avoided during pregnancy wherever possible. If travel to such areas is necessary, insect repellents, bed nets and appropriate clothing to prevent mosquito bites should be used.
The limited available data on atovaquone:proguanil use in human pregnancy relate mainly to its use in the treatment rather than in the chemoprophylaxis of malaria. These data do not indicate an increased risk of congenital malformation, fetal loss, low birth weight or preterm delivery as a consequence of Malarone® use during pregnancy. However, it should be noted that data is limited and there are methodical issues with the studies. There does not appear to be any adverse neurodevelopmental consequence of exposure, although this data comes from a single, small study. Maternal malarial infection is potentially life-threatening, therefore the choice of antimalarial should be guided by drug sensitivity in the region of exposure and not necessarily on pregnancy safety data alone.
Where use of atovaquone:proguanil is indicated, for example in areas of chloroquine or multidrug resistant falciparum malaria, it should not be withheld on account of pregnancy. Proguanil is a folate antagonist and there are therefore theoretical concerns of an associated increase in the risk of congenital malformations associated with folate deficiency. Pregnant women should be advised to take high dose folic acid (5mg daily) in conjunction with atovaquone:proguanil.
Exposure to atovaquone:proguanil at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. Where first trimester exposure to atovaquone:proguanil has occurred, a detailed fetal anomaly scan at 16 weeks may be indicated, particularly if folic acid supplementation was not used. Other risk factors may also be present in individual cases which may independently increase the risk of adverse pregnancy outcome and clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments. Discussion with UKTIS is recommended in all cases.
Important: Please ensure that the selected antimalarial will provide appropriate prophylaxis for the area of travel. Up-to-date advice is available from a number of sources (e.g. BNF, Fit For Travel, Travel Health Pro, and TRAVAX).
For further advice on malaria prevention in pregnancy please refer to the relevant UKTIS document.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.