Hormone Therapy Just Lost Its Black Box Warning. Now the FDA Owes Women Clarity

FACT CHECKED opinion

You likely saw a wave of coverage last week about the FDA removing the agency’s strongest safety alert – the so-called Black Box warning – from hormone therapy (HT) packaging. You may be asking yourself, What does this mean? Has the science changed? Or is the FDA playing politics with women’s health?

If you want to delve into the science and the history, check out MedShadow’s in-depth, evidence-based article, Why Is Hormone Therapy Still So Misunderstood? But here, I want to talk about people’s right to medical information.

Having served on the FDA’s Drug Safety and Risk Management Advisory Committee from 2017 to 2024, I found FDA Commissioner Marty Makary’s announcement on hormone therapy (HT) this past week to be highly significant — and concerning.

I’ll let the doctors and researchers debate the science, but what stands out to me is the question of how best to uphold women’s right to be informed. Commissioner Makary and supporters of this labeling change argue that the existing warning relies on research from 2002 and overlooks the benefits that women deserve to know. Critics counter that HT still carries life-changing risks for many women, and the Black Box warning plays a vital role in ensuring those risks are not overlooked.

I propose that the responsible solution is to keep the essential prescribing guidance prominently displayed on the packaging — not as a Black Box warning, but still in unmistakably clear, visible terms so that women and doctors have complete information on the appropriate timing for starting HT and identifying high-risk groups.

The FDA accomplished this balancing act with the progestin-only contraceptive Opill in May 2023. The Opill applied to the FDA to be the first oral contraceptive sold over the counter. The FDA required Opill’s manufacturer to create packaging that clearly indicated who the Opill was useful for and for whom it could be harmful. My job, along with others on the Advisory Committee, was to review label comprehension studies to ensure that by reading the box, people could self-select if the Opill was appropriate for them to use. Opill used a drug facts label on the outside of the box, which is required for OTC products, along with info on the Opill blister packs, and a short, colorful consumer information leaflet in each box.

Based on the research provided, the Committee unanimously voted that women can understand plain language information and make informed health decisions. Opill was approved for over-the-counter sale.

Can this be implemented for HT drugs? Certainly. Women who can safely use HT and potentially benefit from it are clearly defined and specific: HT must be initiated within 10 years of starting menopause, preferably at the onset and/or before the age of 60. For all other women, and potentially those who have underlying conditions — such as elevated cardiovascular risk, diabetes, obesity, blood-clot history, autoimmune disease or breast cancer — The risks of using HT may rise.

And since a woman’s health can change, it may be beneficial to remind women every time they see the package to consider whether HT is still a good choice for them.

At the press conference and in the subsequent press release, the FDA made only the vaguest statement about plans to include warnings in the package insert to fulfill the requirement to inform. However, most patient package inserts often are very long, and typically folded, origami-like, into a small rectangle and stuck inside drug packaging. Have you ever taken the time to unfold these inserts and read them through? Me either.

The specific language for the new HT warnings and their placement should have been made concurrently with the decision to require manufacturers to remove the Black Box. Further, it should have been workshopped with a committee of the kind I was on. To delete a warning without clearly “showing and telling” what the replacement will be is, frankly, reckless. The fact is, a warning is a protection. Without one, it’s like a contractor coming to your house, ripping off your old roof, and telling you he’ll let you know some unspecified time later what your new roof will look like and when he plans to install it. Meanwhile, you are left guessing and unprotected.

The packaging for HT should be clear, conspicuous, and informative. It should clearly define the group of women who can use HT safely and those who cannot. Women can make their own assessment of risk and benefit, but only if the necessary information is easily accessible.