SYDNEY, April 1 (Xinhua) -- Using quit-smoking treatments such as nicotine patches and varenicline does not increase the risk of major birth defects, providing reassurance for pregnant women, according to a study published on Tuesday.

Real-world data showed no evidence that infants exposed to these medicines had higher rates of major congenital malformations, according to the large multinational study led by the National Drug and Alcohol Research Centre (NDARC) at the University of New South Wales (UNSW Sydney).

The study analyzed data from 5.2 million births across Australia's New South Wales, New Zealand, Norway, and Sweden between 2001 and 2020.

Researchers examined over 13,000 newborns exposed to nicotine replacement therapy (NRT), varenicline, or bupropion and compared their risk of congenital malformations to babies born to women who smoked during early pregnancy but did not use these therapies.

The results found no increased risk of major birth defects in infants whose mothers used NRT or varenicline, said the study published in JAMA Internal Medicine.

"Considering the devastating consequences of smoking on both mother and baby, our results should reassure pregnant women who need help quitting smoking," said Duong Tran, an NDARC research fellow and the study's first author.

Despite their proven effectiveness in the general population, clinical guidelines have advised caution when using NRT during pregnancy and discouraged varenicline and bupropion due to limited safety data, the study said.

Alys Havard, NDARC deputy director and the study's principal investigator, said beyond individual patient care, these findings could inform clinical guidelines and policies on managing smoking during pregnancy. Enditem

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