Source
FDA label update, November 2025; labeling effective February 2026
Linked Research Intelligence
Domain 05 — Menopause & Midlife Health
In effect. FDA label updated. Most practice protocols have not yet been revised.
Update menopause care protocols. For women under 60 and within 10 years of menopause onset, benefits outweigh risks. Denying HRT to eligible women is now below standard of care. Train clinical staff. Expect increased patient inquiries.
For OB Providers
Liability flipped overnight: denying HRT to eligible women is now below standard of care. 1.3M women annually experience severe vasomotor symptoms with no treatment. Current evidence: for women under 60 and within 10 years of menopause onset, benefits outweigh risks. Update your protocols. Train staff. Expect patient questions.
For Midwives
CNMs: if you have menopause patients, you can now offer HRT without the black box liability. CPMs: referral to OB or nurse practitioner for HRT evaluation is appropriate. Menopause is a legitimate medical condition with effective treatment. Women have been undertreated for 24 years.
For Birth Workers & Doulas
Menopause is not an emergency, but hot flashes and night sweats can be disabling. For decades, doctors were scared to prescribe HRT because of a warning label. That warning is gone. If you have menopausal clients, encourage them to talk to their doctor about HRT options. It's safe and effective for most women.
For Institutional Leaders
Standard of care shifted: denying HRT to eligible women is now a liability. 1.3M women annually with severe vasomotor symptoms. Update practice guidelines, train clinicians, and ensure HRT is accessible. This is a protocol change with liability and market implications.
For Everyone
If you're going through menopause: hot flashes, night sweats, and mood changes are real medical symptoms. For 24 years, doctors were cautious about treating them with hormone therapy. The FDA just said hormone therapy is safe and effective for most women in menopause. If you're suffering, ask your doctor about it.
Read the full analysis →
Source
FDA Drug Shortages Database; CDC STI Surveillance (eliminated)
Linked Research Intelligence
Signal 02 — Congenital Syphilis Surge (Domain 01)
Bicillin L-A remains in shortage. No substitutes for congenital syphilis prevention. CDC STI surveillance team eliminated. $440–$1,037 per syringe.
Verify Bicillin L-A supply chain at your facility. Check maternal RPR/VDRL at first prenatal visit AND third trimester. Treat empirically if positive — do not wait for titer confirmation. Secure supply proactively. Partner notification and treatment are essential.
For OB Providers
Congenital syphilis cases: 335 (2012) → 4,000 (2024). Bicillin is in shortage and costs $440–$1,037 per syringe. The CDC team tracking this was fired. Check RPR/VDRL at first prenatal visit and third trimester. Treat empirically if positive. Secure your facility's supply now.
For Midwives
CNMs: You have access to penicillin protocols in hospital settings — verify supply. CPMs: Include routine serologic screening at first visit and late pregnancy. Partner with your backup OB on all positive cases. Bicillin shortage means treatment delays are real.
For Birth Workers & Doulas
Syphilis is treatable but catastrophic if missed. The cure is one shot of penicillin, but there's a shortage. Encourage all pregnant clients to get prenatal care early and ask about syphilis screening. If someone can't access care, help them find a community health center.
For Institutional Leaders
Bicillin L-A shortages are delaying treatment for a preventable catastrophe. 282 infants died or were permanently disabled in 2022. Ensure prenatal screening protocols are robust, secure supply chain, and train staff on empiric treatment. Budget for supply chain contingency.
For Everyone
If you're pregnant: ask your doctor about syphilis screening. It's a simple blood test. The treatment is one shot. There's currently a shortage of the medication, so early detection matters even more. Every pregnant person should be screened.
Guideline
ACOG Committee Opinion No. 518 (reaffirmed 2024) — Intimate Partner Violence
Linked Research Intelligence
Signal 01 — Maternal Homicide (Domain 18)
ACOG recommends universal IPV screening at every prenatal visit. Compliance rates are estimated below 40% nationally. No federal screening mandate exists.
Implement universal IPV screening at every prenatal visit. Use validated screening tools (HITS, AAS, or PVS). Document in social history. Establish referral pathways to social work, DV shelters, and legal aid. Train all clinical staff on compassionate disclosure response.
For OB Providers
Maternal homicide is the #1 cause of pregnancy-related death. ACOG recommends IPV screening at every prenatal visit, but compliance is below 40%. Screen using validated tools. Document as social history. Your referral to social work and legal aid is a clinical intervention with mortality benefit.
For Midwives
CNMs: Use screening protocols and DV documentation in your charts. CPMs: Screen clients at intake and first visit. Out-of-hospital birth carries additional risk if IPV is present. Partner with local DV agencies for warm referrals.
For Birth Workers & Doulas
You are often the first person a client trusts enough to disclose abuse. Have local DV hotlines, shelters, and legal aid numbers ready. If a client discloses, believe her. Know your scope — you can't provide therapy, but you can provide compassion and concrete resources.
For Institutional Leaders
ACOG recommends universal IPV screening. Compliance is below 40%. Develop mandatory screening protocols, staff training, social work integration, and trauma-informed care standards. Establish partnerships with local DV services. This is a staffing, liability, and outcomes issue.
For Everyone
If you are pregnant: your doctor should be asking if you feel safe at home. This is a standard part of prenatal care. If they don't ask, you can still tell them. If you feel unsafe, there are free resources: call 1-800-799-7233 or text START to 88788.