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 are limited to two individual case reports which each describe healthy pregnancy, fetal and infant outcomes following amifampridine and dalfampridine exposure in pregnancy, respectively. As there are currently no controlled studies, and published evidence is highly limited, it is not possible to state the risks, if any, posed to a developing fetus following exposure during pregnancy.
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.
Due to the unknown effects of in utero fetal amifampridine or dalfampridine exposure, additional monitoring of maternal and fetal wellbeing may be warranted. Discussion with UKTIS is recommended in all cases. Other risk factors may also 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.
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.