Is Hormone Replacement Therapy for Menopause Safe?
November 18, 2025
After over 20 years, the U.S. Food and Drug Administration (FDA) is removing the black box warning on hormone replacement therapies (HRT) prescribed to treat symptoms associated with menopause. The black box warning on HRTs, the strongest warning on prescription medications, was based on a 2002 study linking the medications to breast cancer. However, the FDA says the scientific literature was flawed.
For physicians like Susan Pacana, M.D., a minimally invasive gynecologic surgeon and OB/GYN at Jersey Shore University Medical Center, the removal of the black box warning marks a new era in women’s health.
“I am pleased that the black box warning is being removed, as it will make HRT more accessible and bring greater awareness to its benefits. Reducing stigma around treatments like HRT can have a lasting positive impact on patients' willingness to seek care,” she says.
Why Black Box Warnings Were Placed
The study that spurred the black box warning on HRTs was the Women’s Health Initiative in 2002 (WHI). The WHI suggested there was an increased risk of breast cancer associated with taking HRTs. However, there were several issues with the study.
“The average age of women in the study was 62, older than the typical woman who is seeking treatment for menopausal symptoms. Since the original study, no other evidence has supported the increased risk of breast cancer,” she says.
The same study also showed a connection between HRTs and heart disease and stroke. But, Dr. Pacana once again links the study population being more than 10 years from menopause as a factor. In fact, she says, introducing estrogen within 10 years of menopause can actually reduce the risk of heart disease; it was starting estrogen in women more than 10 years out that showed a connection with heart disease and stroke.
The Benefits of Hormone Replacement Therapy
Hormone replacement therapy (also known as menopausal hormone therapy) is prescribed for women going through perimenopause or menopause. It contains estrogen, progesterone and sometimes testosterone, which replace hormones declining during menopause. Dr. Pacana says HRT can be helpful for women experiencing a range of menopausal symptoms.
Some of the symptoms HRT addresses include:
- Night sweats
- Hot flashes
- Vaginal dryness
- Decreased libido
- Mood changes
In addition, HRT has also been shown to decrease the risk of heart disease and osteoporosis.
Reducing Stigma Around Hormone Replacement Therapy
Although HRTs can be helpful to manage menopause symptoms and improve quality of life, Dr. Pacana says many women still shy away from the medication.
“Social and familial judgment often play a huge role in a woman's health decisions, so the removal of these warnings can empower women to make decisions without external pressures,” she says.
Dr. Pacana also says many women are hesitant to address menopausal symptoms with their doctor. However, she notes that numerous treatments are available that can help.
“Menopausal symptoms are a real issue that interferes with women’s lives, impacting work, sleep, family and social relationships. I hope that the removal of these warnings on HRTs will allow women to seek and find treatment from their physicians,” she says.
Next Steps & Resources
- Meet our experts: Susan Pacana, M.D.
- To make an appointment with Dr. Pacana, call 800-822-8905 or find a gynecologist near you here.
- Learn more about women’s health at Hackensack Meridian Health.
The material provided through HealthU is intended to be used as general information only and should not replace the advice of your physician. Always consult your physician for individual care.
