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Read MoreFor the first time in more than two decades, the Food and Drug Administration (FDA) has removed its highest-level safety warning from over 20 hormone-based treatments approved for menopause symptoms.
The update reflects more current research and aims to support individualized conversations between patients and their care teams. Here’s what the change means and how to understand your options for managing menopause symptoms safely and effectively.
Why did the FDA update its guidance?
The FDA removed the box warning that highlighted risks like heart attack, stroke and dementia. “This change aligns the label with general medical guidelines, which recommend hormone therapy for a limited time in women and people assigned female at birth (AFAB) who are under age 60 and within the early years of the menopause transition, provided they do not have complicating risk factors,” said Laura Tyree, M.D., an OBGYN with Inspira Health.
In recent years, studies have provided a more nuanced understanding of hormone therapy. For many people in their 50s, hormone therapy does not increase the risk of heart disease when started near the onset of menopause symptoms. Risks appear higher for people who begin therapy in their 70s, while findings for those in their 60s remain mixed—reinforcing the importance of individualized decision-making.
Additionally, newer formulations, such as low-dose vaginal estrogen creams and tablets that act locally instead of circulating throughout the entire body, have expanded safer treatment options.
How does hormone therapy work?
“Hormone therapy treats symptoms that can appear when menstruation starts to wind down, causing estrogen and progesterone levels to drop,” said Dr. Tyree. It can relieve common menopause symptoms, such as:
- Hot flashes and night sweats
- Vaginal dryness and discomfort
- Sleep disruption
- Mood changes
- Difficulty concentrating
- Joint aches
- Reduced libido
Hormone therapy comes in several forms, including pills, patches, gels, sprays and vaginal creams. Some therapies deliver hormones throughout the body, while others, such as vaginal estrogen, act mainly on local tissues with minimal systemic absorption.
Does hormone therapy carry risks?
Yes. Like any medication, hormone therapy has risks, but our understanding of those risks has evolved substantially. Risks may include:
- Blood clots
- Stroke
- Gallbladder disease
- Increased breast cancer risk with some long-term estrogen-progestin therapies
“For many people in their 40s and 50s without complex medical histories, these risks are generally low when hormone therapy is started close to the onset of menopause symptoms and used at the lowest effective dose for the shortest amount of time needed,” said Dr. Tyree.
People who begin hormone therapy later in life, especially in their 60s or 70s, may face increased risks. In these situations, the benefits and risks must be weighed carefully with a provider.
What does this update mean for me?
The FDA’s revised guidance underscores the importance of personalized care. Hormone therapy may be a safe and effective option for you if it’s started at the right time and matched to your health history, age, symptoms and risk factors.
Your doctor will consider your full medical history, family history, symptom severity and personal preferences before recommending a treatment plan.
Finding the right approach
Hormone therapy is just one option for menopause management. Nonhormonal treatments—such as certain antidepressants that reduce hot flashes, gabapentin for night sweats, lifestyle changes or over-the-counter vaginal moisturizers—can also provide meaningful relief, either alone or alongside hormone therapy.
Talking with your OB/GYN care team is the best way to choose an approach that fits your goals and daily life. They can help you:
- Understand the benefits and risks of hormone therapy
- Explore hormonal and nonhormonal alternatives
- Choose the form of treatment that best suits your lifestyle
- Adjust your plan over time as your needs change
“If you’re experiencing disruptive menopause symptoms, reach out to your OB/GYN care team,” said Dr. Tyree. “Together, you can review the latest evidence and determine the safest, most effective path forward.”
