The message from FDA Commissioner Dr. Marty Makary is clear: women should not have to endure debilitating menopause symptoms like hot flashes, night sweats, and poor sleep. The FDA is acting on this by announcing the removal of the "black box" warning labels from estrogen-based hormone therapy (HT) products used to treat these symptoms.1
The agency's decision aims to counteract the fear that has made women hesitant to try the therapy and doctors reluctant to prescribe it.
The Science Has Evolved
The original warnings stemmed from the early 2000s following data from the Women's Health Initiative (WHI) study, which suggested HT increased the risks of heart attacks, strokes, blood clots, and breast cancer.
- Outdated Formulation: Women in that study were given a type of HT that is no longer commonly used.
- Late Start: The average age of women in the WHI study was 63, which is now considered too late to safely initiate HT.
Today, experts emphasize a more nuanced understanding of safety and effectiveness, especially when therapy is initiated earlier.
"If you're under age 60 or within ten years of menopause onset, when you start hormone therapy, you're going to see improvements in hot flashes, sweats, fewer sleep disruptions," says Dr. JoAnn Pinkerton, a menopause expert at the University of Virginia Health.
Dr. Pinkerton also highlights that appropriately dosed HT offers protection against bone loss and fractures and potential benefits for heart health, brain fog, and overall quality of life.
Important Reality Check: HT Isn't for Everyone
Despite the revised guidance, HT is not suitable for all women.
- Contraindications: Women with certain medical conditions, such as estrogen-sensitive breast or uterine cancer, or those at high risk for or who have had a heart attack, stroke, blood clot, or pulmonary embolism, should generally avoid it.
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- Personalized Discussion: "It's really important that women have a discussion with an informed health care provider because you want to know what the benefits and risks are for you," Dr. Pinkerton stresses.
Key Considerations for Discussing Hormone Therapy
Here are the critical points to review with your healthcare provider:
| Topic | Expert Recommendations |
| 1. When to Start? | Start estrogen therapy before age 60 or within ten years of menopause onset (one year after your final period). |
| 2. How Long to Stay On? | Generally, women stay on HT for three to five years, but this is flexible. Therapy may be continued for persistent symptoms or bone loss, with annual reassessments. |
| 3. How Has HT Changed? | Newer formulations and delivery methods are available. Transdermal patches, gels, or rings are often preferred over pills for women at risk of blood clots, as they may lower the risk. Doctors can also prescribe micronized progesterone (a bioidentical hormone), which has fewer side effects than the synthetic progestin used in the WHI study. |
| 4. Do All Products Carry the Same Risks? | No. Local estrogen (e.g., low-dose vaginal creams) targets only local symptoms like vaginal dryness and is considered to have negligible risks. Systemic estrogen (pills, patches, gels) is a higher-dose treatment that circulates throughout the body and still carries a risk of side effects. |
Non-Hormonal Alternatives
For women who cannot or choose not to take HT, the FDA has approved two non-hormonal oral medications to treat severe hot flashes: Lynkuet (approved recently) and Veozah (approved in 2023). Both work by targeting the neural activity that causes hot flashes.
Other non-pharmacological methods suggested by the NIH include:
- Limiting alcohol and caffeine.
- Maintaining a healthy body weight.
- Early-stage research suggests hypnotherapy and mindfulness meditation may help.
- Some find relief with herbal remedies like sage, lemon balm, red clover, and licorice.
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