USE OF VARENICLINE IN PREGNANCY
Date of issue: January 2023, Version: 3.0
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. Current NICE guidelines recommend NRT in combination with behavioural support for smoking cessation in pregnancy, and also state that varenicline should not be routinely offered to pregnant women.
Published human pregnancy exposure data for varenicline are provided from two uncontrolled and three prospective cohort studies, which together describe approximately 1,500 exposed pregnancies, around 1,100 of which were exposed in the first trimester. The available evidence does not indicate an increased risk of miscarriage, major congenital malformation, intrauterine death, impaired fetal growth, preterm delivery or neonatal complication. Some studies have suggested lower risks of adverse pregnancy outcomes, such as impaired fetal growth and preterm delivery, among varenicline-exposed pregnancies in comparison with continued smoking in pregnancy.
There are no randomised controlled trials of varenicline use as a smoking cessation treatment in pregnant women. However, a single observational study has provided limited evidence of efficacy, describing an improved smoking cessation rate in comparison with NRT patch users.
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. Current NICE guidelines recommend NRT in combination with behavioural support for smoking cessation in pregnancy, and also state that varenicline should not be routinely offered to pregnant women.
Published human pregnancy exposure data for varenicline are provided from two uncontrolled and three prospective cohort studies, which together describe approximately 1,500 exposed pregnancies, around 1,100 of which were exposed in the first trimester. The available evidence does not indicate an increased risk of miscarriage, major congenital malformation, intrauterine death, impaired fetal growth, preterm delivery or neonatal complication. Some studies have suggested lower risks of adverse pregnancy outcomes, such as impaired fetal growth and preterm delivery, among varenicline-exposed pregnancies in comparison with continued smoking in pregnancy.
There are no randomised controlled trials of varenicline use as a smoking cessation treatment in pregnant women. However, a single observational study has provided limited evidence of efficacy, describing an improved smoking cessation rate in comparison with NRT patch users.
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.