• The FDA is officially requesting the removal of the black box warning on menopausal hormone therapy (HRT)—the strongest warning the agency issues.
• This marks a historic reversal of decades of misinformation that unnecessarily scared millions of women away from safe, effective treatment.

Here’s the background

In 2002 a study called the Women’s Health Initiative or WHI was published as a landmark study on the safety of estrogen. At the time, estrogen was the most prescribed medication in the United States. The WHI published inaccurate data due to poor study design. It wrongly stated that estrogen increased the risk of breast cancer and heart disease in women.

The day the WHI results were released in the news (the actual study wasn’t published for more than a week later) millions of women threw away their estrogen out of fear, and doctors stopped prescribing it. Users went from roughly 50% of women to less than 5% almost overnight. On a personal note, just at this time, my wife had surgery that threw her into early menopause, and none of her doctors wanted to treat her. For that reason, I transitioned from being a leading infertility expert to focusing on menopause to figure out if this was accurate so my wife and patients wouldn’t have to tough out the symptoms of menopause. The study caused a generation of women to suffer through their symptoms.

Why This Matters

• For over 20 years, women were told HRT could increase fatal breast cancer.
• Clinical trials do not support that claim.
• The negative reputation was based on a misunderstood 2002 Women’s Health Initiative finding that the small, non-fatal increase in breast cancer (1 per 1,000 women) was not even statistically significant.
• The study design made assumptions based on starting estrogen mostly in women over the age of 60.
• It involved using a synthetic progestin (medroxyprogesterone acetate) that was the likely culprit.

What HRT Really Does

• Relieves menopausal symptoms: hot flashes, night sweats, mood swings, weight gain.
• Major long-term benefits when started within 10 years of menopause:

Up to 50% reduction in fatal coronary events (heart disease is the No. 1 killer of women).

Up to64% reduction in cognitive decline and 35% lower Alzheimer’s risk in key studies.

50%–60% reduction in hip and forearm fractures through osteoporosis prevention.

How the Black Box Warning Harmed Women

• HRT use dropped from nearly half of postmenopausal women (1999) to about 5% (2020).
• Many women were told to take the lowest dose for the shortest time, missing long-term benefits.
• Medical education suffered:
• Only 20% of OB-GYN residents reported formal menopause training
• Many women were prescribed antidepressants instead of estrogen.

Why This FDA Action Is a Breakthrough

• It dismantles one of the most persistent myths in modern medicine.
• It signals a move toward evidence-based, stigma-free menopause care.
• It encourages clinicians to re-evaluate outdated beliefs and offer women the full range of effective treatments.

This is a transformational moment for women’s health and long overdue.

If you want to understand how the WHI and the FDA made such an error in their thinking, consider reading my best-selling book The Estrogen Fix. This information will help you to become a partner in your menopausal healthcare.