USE OF BUPROPION IN PREGNANCY
Date of issue: April 2023, Version: 4
Bupropion is a noradrenaline and dopamine selective reuptake inhibitor (NDRI) licensed for use as a smoking cessation aid in the UK. In other countries bupropion is also licensed for use at a higher dose as an antidepressant. More recently, the long-acting form of bupropion has been used off-label in the treatment of attention deficit hyperactivity disorder (ADHD). Much of the available pregnancy exposure data are collected from studies investigating its use as an antidepressant, which limits the conclusions we are able to provide concerning its use as a smoking cessation aid.
Published human pregnancy exposure data do not currently provide evidence of an increased risk of miscarriage, major congenital malformation overall, cardiac malformation overall, intrauterine death, low birth weight or preterm delivery following maternal bupropion use in pregnancy. Although single case-control studies have suggested possible associations with specific cardiac malformations, including coarctation of the aorta and ventricular septal defects, as well as diaphragmatic hernia, these observations have not been replicated in other studies.
One study has provided evidence that there may be an increased risk of ADHD in the offspring of women who were treated with bupropion for depression. However, this finding was based on a small number of exposed infants with ADHD, resulting in an imprecise risk estimate which may have been confounded by the underlying maternal condition. This observation therefore requires confirmation in further studies.
Tobacco smoking during pregnancy is associated with a higher risk of adverse pregnancy and offspring outcomes, and smoking cessation is therefore strongly advised for both women considering pregnancy and those already pregnant. Where bupropion use during pregnancy is being considered, patients should be made aware of the limited efficacy and pregnancy safety data, and other therapeutic options should be discussed. Current NICE guidelines recommend NRT in combination with behavioural support for smoking cessation in pregnancy, and also state that bupropion should not be routinely offered to pregnant women.
Exposure to bupropion at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. 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.
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.