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USE OF 3,4-DIAMINOPYRIDINE (3,4-DAP, AMIFAMPRIDINE) IN PREGNANCY

Date of issue: May 2016
Version: 1.1

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.

Summary

Amifampridine (3,4-DAP, 3,4-diaminopyridine) is an orphan drug licensed in the EU for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). It is also used in the management of congenital myasthenic syndromes. The related potassium channel blocking drug dalfampridine (4-aminopyridine) is indicated for use in adult patients with multiple sclerosis who have associated walking disability.

Published data on amifampridine exposure is limited to a single case report and it is therefore not possible to state the risks, if any, posed to a developing fetus following exposure during pregnancy. There are no published human pregnancy data on use of dalfampridine. If use is considered necessary to control the maternal condition and continued treatment during pregnancy is being considered, it is important that women are made aware of the lack of human pregnancy safety data when weighing up the risks and benefits of treatment.

Inadvertent exposure to amifampridine or dalfampridine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. Due to the unknown effects of gestational administration of amifampridine or dalfampridine, additional monitoring of maternal and fetal wellbeing may be warranted. Discussion with UKTIS is recommended in all cases.
                      
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.