Safety Considerations and Contraindications


The U.S. Preventative Services Task Force and the Surgeon General have indicated that while pharmacology is effective for smokers in the general population, the evidence is inconclusive to determine the efficacy or safety of use during pregnancy (USDHHS, 2010). Data Safety monitoring committees have frequently halted trials using Nicotine Replacement Therapy (NRT) due to suspected correlation with adverse outcomes for the fetus and/or an inability to demonstrate effectiveness. While one randomized control study found significant differences in abstinence rates for women using NRT, it was terminated early because of an observed higher incidence of adverse events, notably preterm birth, in the NRT group (Pollack, 2007). Another found that nicotine substitutes during the first 12 weeks in pregnancy were associated with a very small but significant increase in congenital malformations compared to mothers who smoked during the first trimester (Morales-Suárez-Varela, 2006).

Bupropion, an anti-depressant has been shown effective for the general smokers but the safety is unknown for pregnant women (Fiore et al., 2008; Lumley et al., 2009). Some adverse risks for bupropion include increased risk for suicide, insomnia and rhinitis. Providers should use extreme discretion and a case-by-case basis for pregnant patients who choose to try smoking cessation medications during pregnancy: patients should be informed of the risks and carefully supervised.

Heavy Smokers

Unfortunately the effectiveness of the 5 A's (Please see Know the Guidelines section) approach is diminished when applied to heavy smokers. Approximately 38% of the women who smoke during pregnancy report being heavy smokers, defined as 20 cigarettes or more per day. These women may need additional assistance out of the ability or scope of a Clinician. Referring these women to the quit-line or more intensive behavioral counseling is recommended.