Bupropion (Smoking cessation indication) - Medication and Pregnancy KB

Bupropion (Smoking cessation indication)

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Bérard (Controls exposed to nicotine patch) 2016	Canada 1998 - 2009 retrospective cohort (claims database)	The Quebec Pregnancy Cohort, built with the linkage of 4 databases in 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.	during pregnancy (anytime or not specified)	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 exposed to nicotine patch) 2016	Canada 1998 - 2009 retrospective cohort (claims database)		The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration). To collect data on nicotine patch replacement therapy purchased over the counter, a random sample of 8505 women taken within the QPC were asked to fill annually a standardized questionnaire.		during pregnancy (anytime or not specified)	72 / 316
Bérard (Controls unexposed, sick) 2016	Canada 1998 - 2009 retrospective cohort (claims database)	The Quebec Pregnancy Cohort, built with the linkage of 4 databases in 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.	during pregnancy (anytime or not specified)	72 / 900	Exclusion of women diagnosed with depression during pregnancy; or women exposed to known teratogens or fetotoxic drugs including antiepilepticdrugs during pregnancy.
Bérard (Controls unexposed, sick) 2016	Canada 1998 - 2009 retrospective cohort (claims database)		The Quebec Public Prescription Drug Insurance database (drug name, start date, dosage, duration). To collect data on nicotine patch replacement therapy purchased over the counter, a random sample of 8505 women taken within the QPC were asked to fill annually a standardized questionnaire.		during pregnancy (anytime or not specified)	72 / 900
Kranzler 2021	USA 2014 - 2020 randomized controlled trial	A multi-site, placebo-controlled, randomized clinical trial conducted in Newark and Philadelphia, USA.	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.	2nd and/or 3rd trimester	64 / 65
Kranzler 2021	USA 2014 - 2020 randomized controlled trial		Participants randomly assigned them to receive 10 weeks of treatment with bupropion or placebo, under double-blind conditions. To promote medication adherence, a personalized text-messaging system was used and designed to be highly relevant to pregnant women.		2nd and/or 3rd trimester	64 / 65
Nanovskaya 2017	USA Not specified. randomized controlled trial	A randomized, prospective, double-blind placebo-controlled, University of Texas Medical Branch (UTMB) Ob/Gyn Department clinics and the UTMB Regional Maternal Child Health Program (RMCHP) clinics.	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.	2nd and/or 3rd trimester	30 / 35
Nanovskaya 2017	USA Not specified. randomized controlled trial		Participants received bupropion or placebo. To confirm use of medication, participants keep a daily diary of the number of pills taken. Subjects then returned the study drug bottles to the research nurse who performed pill counts. Compliance to study medication was also biochemically confirmed.		2nd and/or 3rd trimester	30 / 35
Tran 2025	Australia, New Zealand (Norway and Sweden not included) 2002 - 2020 retrospective cohort (claims database)	Administrative data from New Zealand (NZ), Australia (New South Wales only) (National Maternity Collection, Pharmaceutical Collection, Perinatal Data Collection, ...).	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.	1st 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 2025			Bupropion are prescription-only medicines and were captured by dispensing data (Pharmaceutical Collection and Pharmaceutical Benefits Scheme databases).		1st trimester	1042 / 10318
Tran (Controls exposed to Nicotine replacement therapy) 2020	Australia 2004 - 2012 retrospective cohort (claims database)	The Smoking MUMS (Maternal Use of Medications and Safety) Study	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.	during pregnancy (anytime or not specified)	232 / 328
			Dispensing data for pharmaceuticals subsidised through the Pharmaceutical Benefits Scheme (PBS, 2003–2013).		during pregnancy (anytime or not specified)	232 / 328
Tran (Controls unexposed, sick) 2020	Australia 2004 - 2012 retrospective cohort (claims database)	The Smoking MUMS (Maternal Use of Medications and Safety) Study, in 2 states (New South Wales and Western Australia), Australia.	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.	during pregnancy (anytime or not specified)	232 / 2320
Tran (Controls unexposed, sick) 2020			Dispensing data for pharmaceuticals subsidised through the Pharmaceutical Benefits Scheme (PBS, 2003–2013).		during pregnancy (anytime or not specified)	232 / 2320

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

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

master protocol