USE OF FLECAINIDE IN PREGNANCY

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(Date of issue: August 2019, Version: 2)

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 flecainide use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Flecainide is a class Ic antiarrhythmic licensed for the treatment of AV nodal reciprocating tachycardia, arrhythmias associated with accessory conducting pathways, paroxysmal ventricular arrhythmia where the symptoms are severe and life-threatening, and paroxysmal atrial arrhythmias. It is also used occasionally as an off-license treatment for intrauterine fetal arrhythmia.

The available human pregnancy data primarily consist of a small retrospective cohort study, case reports and small case series documenting maternal flecainide administration to treat fetal tachyarrhythmias. One meta-analysis has been published; however the aim was to evaluate the efficacy of transplacental treatment of fetal tachyarrhythmia, therefore limited pregnancy outcome information was reported. Furthermore, pregnancy outcomes in these reports are influenced by the underlying fetal arrhythmia for which flecainide was administered.

The number of confirmed first trimester-exposed infants identified in the literature is limited to three cases. Therefore, it is not possible to provide an accurate assessment of the risk of congenital malformation following flecainide exposure. Case series/case reports describing preterm delivery, low birth weight, intrauterine/neonatal death and neurodevelopmental delay have been published. However, these are likely to be confounded by fetal arrhythmia, for which flecainide was prescribed to treat. Given the lack of controlled prospective studies, limited conclusions regarding the fetal effects of flecainide exposure can be provided.

Maternal arrhythmia in pregnancy may impact on haemodynamic stability and placental perfusion, with potential risks to the developing fetus. Similarly, fetal arrhythmia poses a serious risk of adverse pregnancy outcome. Where flecainide is needed to treat either a maternal or fetal arrhythmia, it should not be withheld for drug safety concerns. Given the arrhythmogenic side effects of flecainide, additional fetal and maternal monitoring is required. Treatment should be overseen by a clinician with experience in treating fetal or maternal arrhythmia.

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.