Good Morning!

This week’s lead isn’t “bad pharma”—it’s how post-market signals should flow faster from evidence → labels → EHRs → patient alerts. I unpack the Depo-Provera lawsuit as a systems case study, share two timely events, and wrap with a crisp roundup you can skim in a minute.

Inside:

• Depo-Provera & meningioma: what the 2024 study found, why regulators diverged, and a smarter signal→label→patient pipeline.

• Event: WHRAC Webinar—PMDD Uncovered (Wed, Oct 15, 2–3 PM ET, Zoom).

• Event: Women’s Health Horizons (Oct 15–16, Boston — I’m speaking).

• Roundup: FDA weighing a vaginal estrogen label change; robots in IVF; skin cells → human eggs; a kid’s brilliant neurodiversity talk; the Shecanter uterus decanter.

Separately, it is Mental Illness Awareness Week. We’d all agree we need better resources and better education. Fempower Health’s contribution are these resources and expert interviews covering all life stages.

Let’s get into it.

IN THE HEADLINES

🧠 Depo-Provera, Meningioma & The System Gap — Highlights

You’ve likely seen the headlines. Here’s the short version so you can make sense of it without alarm.

How it all Started

A national case–control study in BMJ found that prolonged use (≥1 year) of high-dose systemic progestogens—including injectable medroxyprogesterone acetate (MPA) (i.e., Depo-Provera)—was associated with higher odds of intracranial meningioma. Levonorgestrel IUDs showed no excess risk. Absolute risk remains small.

What is a Meningioma?

Meningiomas are tumours of the tissue layer surrounding the brain and spinal cord. Usually they are benign (non-cancerous) and grow slowly but, depending on the size or location, they can cause serious problems.

How regulators responded

• European Medicines Association (EMA)/Pharmacovigilance Risk Assessment Committee (PRAC) flagged an increased risk with high-dose MPA over several years and recommended risk-minimization measures.

• As of October 2024, in agreement with UK Medicines and Healthcare Products Regulatory Agency (MHRA) Pfizer sent a “Dear Doctor” letter about risks and risk mitigation strategies.

• U.S. FDA has not made label change (to date)  

Why U.S. headlines mention lawsuits

Federal cases have been centralized in a multi-district litigation (MDL) in the Northern District of Florida. Pfizer argues it tried to add a warning but the FDA rejected it for insufficient evidence, so state “failure-to-warn” claims are pre-empted. Plaintiffs dispute this.

How to interpret risk:

• The signal concentrates with longer, multi-year use of high-dose systemic progestins. 

• Most users will never develop a meningioma (low absolute risk), but alternatives exist that didn’t show a signal in this dataset (e.g., Levenorgestrel IUDs).

• New neurologic symptoms (persistent headaches, vision changes, seizures) warrant medical attention regardless of method.

A Better Way Forward

Post-market studies surface new safety signals constantly; the fix isn’t more headlines, it’s a tighter pipeline: real-world evidence flows to regulators through agreed criteria, triggers rapid, time-boxed label addenda, and pushes the same language into EHRs for clinicians and into patient portals for patients—each cross-referencing a person’s medication list and duration of use with live evidence and current labels.

Example: “New evidence suggests a small, duration-related risk with your medication. Here’s what’s known and questions to discuss with your clinician.”

That’s personalized pharmacovigilance—faster, harmonized, and backed by checks-and-balances across manufacturers, regulators, clinicians, and tech platforms, so the right person gets the right information at the right time.

👉 Got a real-world ‘I wish my EHR…’ example? Reply and tell me.

EVENTS

What’s Happening Next Week?

Women’s Health Horizons — I’m Speaking
Oct 15–16, 2025 • Boston, MA

Join women’s health innovators, leaders, and changemakers—from FemTech founders and VCs to policymakers, patient voices, payers, providers, life science leaders, and advocacy experts.

Sign up to attend. 

WHRAC Webinar: PMDD Uncovered
Wed, Oct 15, 2025 • 2:00–3:00 PM ET • Zoom (link after Eventbrite registration)

PMDD is a severe, cyclical hormone-based mood disorder that’s often missed in practice. Dr. Laetitia Meyrueix, PhD—an interdisciplinary scientist and advocate with lived experience—will cover what PMDD is, why it’s overlooked, biology/clinical drivers, care & support strategies, and trusted resources (incl. IAPMD).

Register on Eventbrite and please share with colleagues.

ROUNDUP

What Caught My Eye

🏷️ Vaginal Estrogen Label Under Review
FDA says it’s strongly considering a label change for vaginal estrogen—important for GSM, recurrent UTIs, and pain with sex. Here’s the quick explainer.
👉 Watch the TikTok

🤖 Robotics for IVF
AI + robots are starting to automate parts of IVF to boost precision and lower costs—but these systems are experimentaland not yet approved in the U.S.
👉 Read the article

🧬 Skin Cells → Human Eggs?
Researchers report imperfect but fertilisable human eggs made from skin cells—a potential breakthrough for infertility, with big scientific and ethical questions ahead.
👉 Read the Economist explainer

💡 “Limited-Edition LEGO”: A Kid Explains Neurodiversity
Twelve-year-old Leo’s award-winning talk reframes autism and ADHD with clarity and heart—great to share with kids, families, and educators.
👉 Watch the reel

🍷 The Shecanter (Yes, a Uterus Decanter)
A conversation piece that turns reproductive health into table talk—sold out, but worth a follow for restocks and the message behind it.
👉 Watch the video & follow

👉 Have something for me to share with this group? Reply to this email. 🙏🏼