Pregnant women seeking help to quit smoking can be reassured that medications like nicotine patches and varenicline do not increase the risk of major birth defects in their babies, according to new research from the National Drug and Alcohol Research Center (NDARC) at UNSW Sydney.
Published in JAMA Internal Medicine, the study analyzed real-world data and found no evidence that infants exposed to quit-smoking medications had higher rates of congenital malformations. The findings offer reassurance to pregnant women and healthcare providers regarding the safety of smoking cessation treatments.
Dr. Duong Tran, NDARC Research Fellow and lead author of the study, emphasized the importance of these results. “Considering the devastating consequences of smoking on both mother and baby, our findings should provide confidence to pregnant women in need of assistance to quit smoking,” he said. “These results also support healthcare providers in helping women make informed decisions about quitting during pregnancy.”
Currently, nicotine replacement therapy (NRT), varenicline, and bupropion are available through the Pharmaceutical Benefits Scheme and are proven to be safe and effective for the general population. However, clinical guidelines for pregnancy have typically recommended caution regarding their use due to a lack of clear evidence on their safety in pregnant women.
The study, a large multinational effort, analyzed data from 5.2 million births in Australia, New Zealand, Norway, and Sweden between 2001 and 2020. The researchers focused on over 13,000 newborns—9,300 of whom were exposed to NRT, 3,000 to varenicline, and 1,000 to bupropion—and compared the risk of birth defects in these infants to those born to women who smoked during early pregnancy but did not use these medications.
The results revealed no increased risk of birth defects in babies born to women who used quit-smoking medicines compared to those who smoked without these therapies. The study also found no higher risk of heart, limb, genital, kidney, urinary tract, respiratory, digestive, or facial defects among infants exposed to NRT or varenicline.
However, the authors noted that the small number of women using bupropion during pregnancy prevented them from drawing definitive conclusions regarding its safety. They called for further research with a larger sample size to assess potential risks.
“This study is the largest of its kind and provides robust evidence on the safety of quit-smoking medications during pregnancy,” said Dr. Tran. “Since pregnant women are often excluded from clinical trials, observational studies like ours are crucial in filling knowledge gaps and guiding healthcare decisions.”
Associate Professor Alys Havard, NDARC Deputy Director and principal investigator of the study, emphasized the broader implications of the research. “This study not only benefits individual patient care but also has the potential to inform clinical guidelines and policies on managing smoking during pregnancy and prescribing quit-smoking medications for expectant mothers,” she said.
While the study provides valuable insights into the safety of smoking cessation medications, the authors cautioned that further research is needed to evaluate the long-term effects of these treatments, such as their impact on neurodevelopmental outcomes.
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