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Risk of Major Congenital Malformations Following Prenatal Exposure to Smoking Cessation Medicines

Tran DT, et al. Risk of Major Congenital Malformations Following Prenatal Exposure to Smoking Cessation Medicines. JAMA Intern Med. Published online March 31, 2025. doi:10.1001/jamainternmed.2025.0290

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2831910

“In this cohort study of 5.2 million births in Australia (state of New South Wales), New Zealand, Norway, and Sweden, there was no increased risk of major congenital malformations (MCMs) overall following exposure to NRT (9325 infants), varenicline (3031 infants), or bupropion (1042 infants). The study found no evidence of a higher risk of several malformation subgroups for NRT or varenicline, while the risk of malformation subgroups could not be estimated robustly for bupropion.

The results of this study suggest that, considering the harms of smoking, it is reassuring that prenatal use of NRT and varenicline for smoking cessation was not associated with increased risks of MCMs compared with smoking during the first trimester.”

TRC Research Commentary

The Trump administration has destroyed the US Tobacco Control workforce and agencies.

“As part of its campaign to wreck the federal government, Brian King, head of the FDA Center for Tobacco Products, has been put on administrative leave. He has reportedly been offered a job with a regional office of the Indian Health Service, including Alaska. (According to the New York Times, “Some senior leaders based in the Washington, D.C., area received notices that they were being reassigned to Indian Health Service territories, a tactic to force people out, employees said, because it would entail moving to other parts of the country.”) This is a huge loss because Brian has been an effective leader who has helped drive youth e-cigarette use down dramatically.”

In addition, “The FDA Center for Tobacco Products Department of Public Health Education is also gone. Overall, the FDA has been crippled as a potential force to regulate tobacco or fight the tobacco epidemic.” From Stanton Glantz’s Blog of April 1, 2025

Stephen Hamann

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