Bupropion (Smoking cessation indication) - Medication and Pregnancy KB

Bupropion (Smoking cessation indication)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Bérard (Controls exposed to nicotine patch), 2016	Canada 1998 - 2009	All live births of pregnant women between 15 and 45 years and smokers before pregnancy, that occurred during the study period in the province of Quebec.	Pregnant women using bupropion alone with or without smoking (that filled prescriptions bupropion during pregnancy or before the first day of gestation with duration overlapping the beginning of pregnancy).	exposed to other treatment, sick Pregnant women using nicotine patch replacement therapy alone with or without smoking.	72 / 316	Exclusion of women diagnosed with depression during pregnancy; or women exposed to known teratogens or fetotoxic drugs including antiepileptic drugs during pregnancy.
Bérard (Controls unexposed, sick), 2016	Canada 1998 - 2009	All live births of pregnant women between 15 and 45 years and smokers before pregnancy, that occurred during the study period in the province of Quebec.	Pregnant women using bupropion alone with or without smoking (that filled prescriptions bupropion during pregnancy or before the first day of gestation with duration overlapping the beginning of pregnancy).	unexposed, sick Pregnant smokers without bupropion or nicotine patch replacement therapy exposures during pregnancy.	72 / 900	Exclusion of women diagnosed with depression during pregnancy; or women exposed to known teratogens or fetotoxic drugs including antiepilepticdrugs during pregnancy.
Kranzler, 2021	USA 2014 - 2020	Pregnant women that smoked ≥3 cigarettes per day for the preceding 7 days; wanted to quit smoking; and were at 13–26 weeks of gestation, ≥18 years old, and able to speak English.	Pregnant women that receive twice daily treatment with bupropion sustained release 150 mg for 10 weeks.	unexposed, sick Pregnant women that receive twice daily matching placebo for 10 weeks.	64 / 65
Nanovskaya, 2017	USA Not specified.	Pregnant smokers ≥ 18 years of age between 13 and 30 weeks’ gestation, smoking ≥ 10 cigarettes per day (CPD) prior to pregnancy and 5 CPD for the preceding 7 days.	Pregnant participants that received bupropion sustained-release (SR) orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.	unexposed, sick Pregnant participants that received matched placebo orally once daily for three days followed by twice daily for a total medication treatment of 12 weeks.	30 / 35
Tran, 2025	Australia, New Zealand (Norway and Sweden not included) 2002 - 2020	Live births among women who were dispensed smoking cessation pharmacotherapy and of women who smoked during the first trimester.	Infants born to women who were dispensed Bupropion only (among smoking cessation pharmacotherapies) during the first trimester, i.e medicine supply overlapping the first trimester (DoC ≤ date of dispensing ≤ DoC 83 or date of dispensing < DoC ≤ date of dispensing days of supply).	unexposed, sick Infants born to women who self-reported that they smoked during the first trimester and were not dispensed a prescribed smoking cessation pharmacotherapy during 90 days before conception and the first trimester.	1042 / 10318	Bupropion analyses included births in NZ (childbirths 2006-2020) and Australia (childbirths 2002-2018), where bupropion is registered only for smoking cessation, but not births in Norway and Sweden (bupropion also available for depression treatment).
Tran (Controls exposed to Nicotine replacement therapy), 2020	Australia 2004 - 2012	Pregnant women who smoked during pregnancy and that resulted in a birth (gestational age ≥ 20 weeks or birthweight ≥ 400 g), in two Australian states.	Pregnant women who were exposed to bupropion, ie with one or more dispensings of the therapy in the gestation period.	exposed to other treatment, sick Pregnant women who were exposed to Nicotine replacement therapy, ie with one or more dispensings of the therapy in the gestation period.	232 / 328
Tran (Controls unexposed, sick), 2020	Australia 2004 - 2012	Pregnant women who smoked during pregnancy and that resulted in a birth (gestational age ≥ 20 weeks or birthweight ≥ 400 g), in two Australian states.	Pregnant women who were exposed to bupropion, ie with one or more dispensings of the therapy in the gestation period.	unexposed, sick Pregnant women who had never been exposed to any of these medicines (bupropion, varenicline and Nicotine replacement therapy) in pregnancy.	232 / 2320

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

Warning! There are no case-control studies available for this drug.

master protocol