Top women's health headlines you missed in November 2025

November 2025 brought a wave of important updates that continue to shape the care of women across all stages of life.

In the ever-evolving field of obstetrics and gynecology, noteworthy advancements emerged in menopause management, urogynecology, contraception, and more.

In this monthly recap, Contemporary OB/GYN highlights the most impactful regulatory news, clinical research findings, and expert perspectives from November 2025.

Click on each title below for in-depth coverage of these key updates.

1. FDA initiates removal of boxed warnings, requests updated labeling for menopausal hormone therapy

The US Department of Health and Human Services and the FDA have announced major revisions to safety labeling for menopausal hormone therapy (MHT), updating boxed warnings and product information to better reflect current evidence. The changes follow a comprehensive review of data published since the original Women’s Health Initiative trials, alongside updated utilization trends and expert input. The FDA noted that WHI participants were significantly older than the women typically prescribed MHT today, prompting removal of boxed warning language related to cardiovascular disease, breast cancer, endometrial cancer (for most products), and probable dementia.

Updated labeling will emphasize that systemic MHT may be appropriate for women younger than 60 years or within 10 years of menopause onset, supported by newer evidence showing reductions in all-cause mortality and fracture risk in this group. Local vaginal estrogen products will also receive streamlined, indication-specific safety information. The policy shift aims to reduce the underuse of MHT and support evidence-based decision-making between patients and clinicians. Alongside these updates, the FDA approved a generic conjugated estrogen product and a nonhormonal therapy for moderate to severe vasomotor symptoms, expanding treatment options for menopausal women.

2. FDA approves fosfomycin for treating cUTIs

The FDA has approved fosfomycin injection (Contepo; Meitheal Pharmaceuticals) for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis, in adults. The therapy offers a novel option with no known cross-resistance to existing antibiotic classes and demonstrated activity against Escherichia coli and Klebsiella pneumoniae, two of the most common pathogens driving cUTIs. In the phase 2/3 ZEUS trial, fosfomycin showed noninferiority to piperacillin–tazobactam, achieving overall success rates of 63.5% vs 55.6%, defined by both clinical cure and microbiologic eradication.

The treatment also demonstrated a favorable safety profile, with the most common adverse events including transaminase elevations, electrolyte abnormalities, and gastrointestinal effects. As a phosphonic acid antibiotic that targets early steps of bacterial cell wall synthesis, fosfomycin provides a mechanistically distinct option for patients with infections caused by resistant gram-negative organisms. With cUTIs accounting for an estimated 3 million hospital-treated cases annually, the approval introduces a much-needed alternative for managing serious infections in an era of rising antimicrobial resistance.

3. FDA grants IDE approval for FemBloc nonsurgical permanent birth control

The FDA has granted investigational device exemption (IDE) approval for FemBloc, a nonsurgical permanent birth control method, allowing enrollment into the final phase of the FINALE pivotal trial. This milestone advances FemBloc toward potential US pre-market approval, which would make it the first nonsurgical permanent contraception option to reach commercialization. The system delivers a proprietary polymer into both fallopian tubes, creating natural scar-tissue occlusion without anesthesia, incisions, or recovery time—offering a safer, more accessible alternative to surgical sterilization.

Clinical data from 3 prospective US trials demonstrated a 99.6% procedural success rate, 0% pregnancy rate, and no serious adverse events, with most mild effects resolving within days. FemBloc has already received regulatory approval in Europe, the UK, and New Zealand, supported by positive 5-year safety and patient satisfaction data, positioning the device as a meaningful innovation for women seeking permanent contraception.

4. Experts recommend postpartum psychosis be classified as its own disorder

An international panel of women’s mental health experts is calling for postpartum psychosis (PP) to be formally recognized as its own diagnostic category, citing distinct clinical features, treatment needs, and severe associated risks. Despite its rapid onset and characteristic presentation, PP is still not listed as a standalone disorder in the DSM or ICD, leading to delayed recognition and care. The consensus statement notes that PP affects 0.1% to 0.2% of women without prior psychiatric history, with a 10-fold increase in psychosis risk in the early weeks postpartum.

The condition is considered a psychiatric emergency requiring inpatient treatment, and evidence shows high remission rates—up to 98%—with stepwise therapy including benzodiazepines, antipsychotics, and lithium. Because suicide is the leading cause of maternal mortality and PP is strongly linked to preventable deaths and infanticide, experts argue that reclassification would support earlier diagnosis, targeted counseling, and prevention strategies for women at the highest risk, such as those with prior bipolar disorder or previous PP.

5. Neurodevelopmental disorder risks not increased by prenatal acetaminophen use

A new systematic review published in the Journal of the American Academy of Child & Adolescent Psychiatry found no causal association between prenatal acetaminophen use and offspring neurodevelopmental disorders (NDDs), reinforcing current recommendations from the CDC, ACOG, and Canadian obstetric societies. Across multiple cohort studies evaluating ADHD, autism spectrum disorder, and other NDDs, investigators reported only small associations that did not persist in sibling-controlled analyses—suggesting confounding factors rather than medication effects.

For ADHD, an observed odds ratio of 1.17 disappeared in sibling comparisons, while autism risk was not meaningfully increased across physician-diagnosed outcomes. The review also found no impact on language or psychomotor development, regardless of duration of use. The authors stressed that misclassification and methodological limitations have contributed to inconsistent findings in earlier studies, and emphasized that well-designed future research should prioritize accurate exposure measurement and sibling-comparison models.