Bupropion appears safe in pregnant women: not linked to increase in major fetal dejects: first study in pregnancy

OB/GYN News, August 15, 2003 by Nicholas Mulcahy

PHILADELPHIA -- Bupropion does not appear to increase the risk for major fetal malformation and seems effective in decreasing smoking in pregnant women, according to interim results of an ongoing trial.

"There is always a question of benefits and risks when taking a drug during pregnancy. However, with our interim study results, a doctor can now know that the drug is probably not associated with malformations," said Brian Chan, who is a researcher with the Motherisk program at the Hospital for Sick Children in Toronto.

The Motherisk study is the first on the use of bupropion during pregnancy, Mr. Chan said at the annual meeting of the Teratology Society.

In the prospective, observational, controlled study, 101 women are enrolled for bupropion treatment (either for smoking cessation or depression) and 100 are enrolled as controls. To date, mean birth weight, gestational age at time of delivery, and rates of birth defects, miscarriages, and therapeutic abortions were not significantly different between the two groups.

In the treatment group, pregnancy outcomes are available for 99 women (69 for antidepressant use and 30 for smoking cessation), and two pregnancies are still pending. There were 73 live births with no birth defects, 18 miscarriages, and 8 therapeutic abortions.

The miscarriage rate in participants taking bupropion as an antidepressant was not significantly different than that of participants taking bupropion as a smoking cessation aid.

The change in cigarettes smoked per day before and during pregnancy for the bupropion group was not different from the control group. The number of participants using bupropion who quit smoking completely during pregnancy was greater than that in the control group (nine vs. three), although the difference is not statistically significant at this point. Mr. Chan added that participants in treatment and control groups were matched for the amount they smoked before their pregnancies.

VITAL SIGNS

Top 10 Drugs Mentioned During Ob.Gyn.
Office Visits in 2002

Percent of all drug mentions:

Prenatal Vitamins            6.2%
Ortho Tri-Cyclen             3.9%
Premarin Tabs                3.7%
Depo-Provera                 2.4%
Provera                      1.9%
Prenate GT                   1.6%
Prempro                      1.8%
Calcium                      1.8%
MetroGel-Vaginal             1.7%
Diflucan                     1.6%

Note: Based on a monthly survey of about 200 office-based
ob.gyns.

Source: Verispan

Note: Table made from bar graph.