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Hormone replacement therapy (HRT) has long been shrouded in caution, with the highest level of regulatory warnings—the “black box” label—attached to many treatments for menopause and hormonal shifts. But this is changing. Earlier this week, the FDA announced that it will remove the black box warning from most hormone therapies. (The warning for endometrial cancer remains for systemic estrogen therapy.)
The FDA’s recent move to revise HRT safety warnings has important implications for women navigating hormonal shifts or weight-loss challenges (especially when using GLP-1 medications). Let’s unpack what this update means.
What’s changed? The FDA’s regulatory update explained
The black box warning, the strongest safety alert the FDA issues, has been linked for years to HRT for menopause symptoms. It warned patients about increased risks of cardiovascular disease, breast cancer, strokes, dementia, and other health issues.
However, many newer forms of HRT drugs have been introduced, more studies have been done on younger women, and more nuanced research has been conducted since the black box warning was first added in the early 2000s. For years, doctors have been calling for the warning to be removed or revised to align with current science and treatment options.
Other safety statements will still be included under warnings and precautions, and clinicians will still review individual risks with patients, but this regulatory shift signals a commitment to science and individual empowerment over legacy assumptions.
Why this matters
Many women who could benefit from HRT opt not to when they see the black box warning, even knowing it could offer significant relief from menopausal symptoms. While rooted in safety, this caution has inadvertently left millions of women to suffer for years without support.
The removal of the label opens the door for more personalized decision-making focused on age, timing, type of treatment, and dosing, not fear and stigma.
While some risk still exists, for most women, the benefits of HRT outweigh the risks. Removing the warning leaves more room for patients and doctors to talk about options and find the best way forward.
What this means for patients, especially if you’re on a GLP-1
This regulatory change opens the door to more nuanced conversations with providers—and more personalized care for patients. With the label change, more providers will feel comfortable prescribing HRT to those who are a good candidate for it, and patients will feel more comfortable taking it. So if hormone imbalance is a barrier to your health goals or your quality of life, the path to getting back to where you want to be is much smoother.
Hormone shifts and weight loss: The less-talked-about barrier
Even if you’re taking a GLP-1 like semaglutide or tirzepatide, hormonal fluctuations can affect your weight-loss efforts.
- Menopause: As estrogen and progesterone levels fall, many women experience increased fat storage (especially around the midsection), slower metabolism, reduced muscle mass, and more difficulty losing weight, even if they’re doing everything “right.”
- Thyroid disorders: Hypothyroidism, even a mild version, can reduce basal metabolic rate, blunt the effect of weight-loss medications, raise fatigue, and make it harder to stay physically active.
- Sex hormone imbalances: These can shift the balance of energy, appetite, muscle-to-fat ratio, and metabolic flexibility.
While HRT may not directly help with weight loss, hormone treatment can have an effect on sleep, mood, and energy, which can indirectly affect weight-loss efforts. HRT does not replace metabolic care—including GLP-1 treatment—but can be part of a holistic approach to help you reach your health goals, especially during perimenopause.
Metabolic supports like NAD+ or MIC + B12 may also help optimize health outcomes.
Where we go from here
Removing the warning label from HRT drugs doesn’t mean you should rush into hormone therapy without thinking about it, but it does provide an opportunity to talk to your doctor about what will be the best course of action for you.
At Shed, we know that many factors contribute to health, from weight loss to hormone balance to nutrition. The FDA’s label update makes whole-body health a more achievable goal for many women, whether they’re trying to lose weight or navigate hormonal shifts.
FAQs
Does the removal of the black box warning mean HRT is completely safe?
For many, the benefits outweigh the risks, but risks still exist depending on your age, delivery method, and medical history. The FDA’s update removes the highest-level warning for many hormone therapies, but it is still important to discuss with your doctor whether HRT is right for you. Individualized treatment plans are key.
If I’m not losing weight on a GLP-1, should I start hormone therapy?
Talk to your doctor before starting new medications (or making changes to the ones you’re already on). They’ll be able to help you get to the bottom of what is happening in your body and what changes, if any, actually need to be made.
When should I start HRT?
If recommended by your provider, it is best to start hormone therapy about 10 years before menopause onset, or before age 60.
This information is for educational purposes only and is not a substitute for medical advice. Please consult your healthcare provider before starting or changing any medication.
