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Benzodiazepine use in first trimester not associated with higher risk for major birth defects

10.12.26 | American College of Physicians

Embargoed for release until 5:00 p.m. ET on Monday 12 October 2026

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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine . The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.
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1. Benzodiazepine use in first trimester not associated with higher risk for major birth defects

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-25-05148

URL goes live when the embargo lifts

A population-based cohort study found that pregnant people who used benzodiazepines during the first trimester were not at a substantially increased risk of having a baby with major birth defects. The rates of overall major congenital malformations were comparable between pregnancies exposed to benzodiazepines and those that were not, providing reassuring evidence about the safety of these medications in early pregnancy. The study is published in Annals of Internal Medicine .

Researchers from Brigham and Women's Hospital and Harvard Medical School and colleagues analyzed data from a cohort of 4.2 million Medicaid and commercially insured pregnancies between 2000 and 2020 to assess the risk of major congenital malformations from first-trimester exposure to benzodiazepines. They compared outcomes among 79,000 people who filled at least one benzodiazepine prescription in early pregnancy with those who did not. The investigators found no meaningful increase in the risk of overall major birth defects and no consistent evidence of organ-specific malformations previously thought to be associated with benzodiazepine exposure. While the authors concluded that first-trimester benzodiazepine exposure was not associated with a meaningful increase in birth defect risk, they note that the safety of benzodiazepine use during pregnancy warrants further research to continue monitoring rare birth defects, longer exposures, and to examine other pregnancy outcomes.

Media contacts: For an embargoed PDF, please contact Gabby Macrina at gmacrina@acponline.org. To contact senior author Krista Huybrechts, MS, PhD, please email McKenzie Ridings at mridings@mgb.org.

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2. Medicare Drug Price Negotiation Program could save patients up to $700 per year

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-26-02703

A brief research report found that Medicare beneficiaries taking several commonly prescribed medications could see substantial savings with the Medicare Drug Price Negotiation Program (MDPNP). Patients enrolled in stand-alone Medicare Part D plans are projected to save an average of $685 annually, while those in Medicare Advantage drug plans could save about $470. The study is published in Annals of Internal Medicine .

Researchers from Vanderbilt University and Harvard Medical School evaluated how the MDPNP, established under the Inflation Reduction Act, will affect patients' out-of-pocket prescription costs in 2026. Using Medicare Part D plan information, drug pricing data, and the newly negotiated prices for nine selected medications, they estimated patient spending before and after the negotiated prices were applied. The study found that beneficiaries using several widely prescribed drugs, including Jardiance, Eliquis, Farxiga, Xarelto, Entresto, and Januvia, could reduce their annual out-of-pocket costs by 26% to 49%. However, beneficiaries taking the highest-priced drugs may see little to no direct out-of-pocket savings because they already reach Medicare's annual prescription drug spending cap. The researchers conclude that negotiated drug prices will provide meaningful savings for many Medicare beneficiaries whose drug spending remains below the annual out-of-pocket cap, while also helping reduce overall Medicare spending.

Media contacts: For an embargoed PDF, please contact Gabby Macrina at gmacrina@acponline.org. To contact corresponding author Stacie B. Dusetzina, PhD, please email Jake Lowary at jacob.lowary@vumc.org.

3. Oral semaglutide for obesity management saw rapid early uptake after FDA approval

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-26-02436

An analysis of prescription data found that the oral form of semaglutide for weight management was adopted at a remarkably fast pace after its January 2026 launch, surpassing 100,000 new prescriptions within just two months. Rather than replacing injectable weight-loss medications, the availability of a pill form appeared to attract new patients to pharmacological obesity treatment. The study is published in Annals of Internal Medicine .

Researchers from Johns Hopkins Ciccarone Center for Cardiovascular Disease Prevention aimed to assess early uptake of oral semaglutide for obesity after FDA approval and whether it expanded the number of people receiving incretin-based weight-loss therapies. Using national U.S. pharmacy prescription data, they analyzed monthly prescriptions for oral semaglutide (Wegovy pill), injectable semaglutide (Wegovy), and tirzepatide (Zepbound) through June 2026. The study found that oral semaglutide had the fastest uptake of any major weight-loss therapy examined and increased overall treatment use without reducing prescriptions for injectable semaglutide. The authors conclude that an oral option may help reach patients who prefer not to use injections, potentially broadening the accessibility of pharmacological obesity treatment.

Media contacts: For an embargoed PDF, please contact Gabby Macrina at gmacrina@acponline.org. To contact corresponding author Michael J. Blaha, MD, MPH, please email mblaha1@jhmi.edu.

4. Experts debate cervical cancer screening strategies for a healthy 26-year-old woman

This “Beyond the Guidelines” feature is based on a discussion held at the Medical Grand Rounds conference at Beth Israel Deaconess Medical Center on 30 April 2026.

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-26-02904

In a new Annals “Beyond the Guidelines” feature, a primary care physician and an obstetrics and gynecology physician discuss the optimal approach to cervical cancer screening in a healthy young woman. The discussion focuses on updated recommendations from the American Cancer Society, the Women’s Preventive Services Initiative, and the draft U.S. Preventive Services Task Force guidelines, which generally favor primary HPV testing but differ on when screening should begin, preferred testing approaches for younger women, and the use of self-collected HPV testing. As such, asking, “How would you screen this 26-year-old woman for cervical cancer?” remains an important clinical question.

The experts reviewed the case of Ms. L, a 26-year-old woman with a history of depression, anxiety, attention deficit hyperactivity disorder, and a prior ovarian cyst rupture. Her mother was diagnosed with ovarian cancer at age 59. She has had three prior negative Papanicolaou (Pap) tests beginning at age 21 years and has no history of sexually transmitted infections or abnormal cervical cancer screening results. She is uncertain of her HPV vaccination status but believes she likely received the vaccine. She is sexually active with one long-term male partner. Ms. L expressed openness to self-collected HPV testing, noting that such an option could improve access and comfort for many patients, particularly survivors of sexual violence.

Both experts agree that persistent infection with high-risk HPV is the primary driver of cervical cancer, and increasing screening participation remains a major public health priority. They also agree that self-collected HPV testing has the potential to improve access and reduce disparities, although questions remain about optimal follow-up strategies after positive results and appropriate screening intervals. The discussion highlights the need to balance test performance, patient preferences, and health system realities when implementing contemporary cervical cancer screening guidelines.

All “Beyond the Guidelines” features are based on selected clinical conferences at Beth Israel Deaconess Medical Center and include multimedia components published in the Annals of Internal Medicine .

Media contacts: For an embargoed PDF, please contact Gabby Macrina at gmacrina@acponline.org. To speak with one of the discussants, please contact Kendra McKinnon at kmckinn1@bidmc.harvard.edu.

Also in this issue:

What Simple Health Policy Models Reveal: Tradeoffs, Uncertainty, and Values

A. David Paltiel, PhD

Ideas and Opinions

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-26-02824

The Legal Battle Over Mifepristone and the Future of FDA Regulation

S. Sean Tu, JD, PhD; Lewis A. Grossman, JD, PhD; and William B. Feldman, MD, DPhil, MPH

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-26-03376

Delirium

Blair P. Golden, MD, MS, and Eduard E. Vasilevskis, MD, MPH

In the Clinic

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-26-03322

Annals of Internal Medicine

10.7326/ANNALS-25-05148

News article

People

Benzodiazepine Use Early in Pregnancy and Risk for Congenital Malformations

13-Oct-2026

Keywords

Article Information

Contact Information

Gabby Macrina
American College of Physicians
gmacrina@acponline.org

How to Cite This Article

APA:
American College of Physicians. (2026, October 12). Benzodiazepine use in first trimester not associated with higher risk for major birth defects. Brightsurf News. https://www.brightsurf.com/news/LKNY79WL/benzodiazepine-use-in-first-trimester-not-associated-with-higher-risk-for-major-birth-defects.html
MLA:
"Benzodiazepine use in first trimester not associated with higher risk for major birth defects." Brightsurf News, Oct. 12 2026, https://www.brightsurf.com/news/LKNY79WL/benzodiazepine-use-in-first-trimester-not-associated-with-higher-risk-for-major-birth-defects.html.