USE OF PROGUANIL IN PREGNANCY

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(Date of issue: November 2018, Version: 3)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on proguanil use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Proguanil is an antimalarial, frequently prescribed with chloroquine or used in combination with atovaquone (as Malarone®) for malaria prophylaxis.

Malaria in pregnancy presents a high risk to both mother and fetus. Travel to areas where malaria is endemic should be avoided during pregnancy wherever possible. If travel to such areas is unavoidable, insect repellents, bed nets and appropriate clothing to prevent mosquito bites should be used. Pregnant women should also be advised to use the most effective malaria chemoprophylaxis for that area and the available pregnancy safety data discussed with the patient.

There are very limited data on proguanil use (as a single agent) in pregnancy. Most of the available studies report on use of proguanil in combination with chloroquine or atovaquone (Malarone®) and involve a low number of first trimester exposures. These data, although extremely limited, have not shown an increased risk of congenital malformation. However, proguanil is a folate antagonist and these data are not robust enough to disprove theoretical concerns that use before or during early pregnancy may increase the risk to the fetus of congenital malformations associated with folate deficiency. It is therefore recommended that pregnant women take high dose folic acid (5mg daily) in conjunction with proguanil.

The limited data investigating proguanil use specifically do not suggest an increased risk of spontaneous abortion, low infant birth weight or preterm delivery and a single study investigating Malarone® (proguanil-atovaquone) exposure found no adverse neurodevelopmental outcomes among a small number of prenatally exposed one year old infants. 

Exposure to proguanil at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.

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,[1] Fit For Travel,[2] NathNAC,[3] TRAVAX[4]).

For further advice on malaria prevention in pregnancy please refer to the relevant UKTIS document below.

This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

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 health care professionals at www.toxbase.org.

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.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.