New FDA Guidance on Hormone Replacement Therapy (HRT): How Updated Labels Could Change Menopause Treatment
Recent changes to the FDA warnings about the use of hormone replacement therapy (HRT) in women has been widely reported in the news. HRT may include estrogen alone or estrogen and progesterone to manage common symptoms of menopause or perimenopause (the transitional period before menopause) such as hot flashes and night sweats as well as changes to the vaginal area and urinary tract. What do these recent changes mean for the prescribing and safety of these medications?
What were the recent changes made by the US Food and Drug Administration (FDA)?
The US Food and Drug Administration recently announced that they are removing Black Box warning from the manufacturer’s prescribing information. Black Box warnings are the FDA’s strongest safety warning they can require for prescription drugs, highlighting the risk of serious or even fatal adverse reactions.
However, these changes do not mean that there are no risks associated with the use of these therapies. Your risk will depend on factors such as your age, your health history, and the length of time you are taking these medications, and the specific product prescribed.
The previous warnings were based on 2002 Women’s Health Initiative (WHI) clinical study in older women (average age of participants was 63 years). This study’s focus was to investigate if hormone therapy could prevent chronic diseases in postmenopausal women; it was not a study designed to evaluate whether HRT was safe or effective for managing menopausal symptoms. Further studies have provided additional insights about the risks and benefits of the use of estrogen products in younger women.
These changes are being made to support doctors and patients to address the use of estrogen and estrogen and progesterone in women that are being affected by symptoms of menopause.
Does this mean that there are no risks with HRT?
No. There are still risks associated with the use of HRT in women, especially in those with certain health issues. Clinical studies have shown risks associated with hormonal (estrogen, progesterone) treatment include heart disease, breast cancer, gallbladder disease, stroke, and blood clots. Also taking estrogen alone (without progesterone) increases the risk of cancer of the uterus. Women who have had breast cancer, liver disease, a stroke, heart attack, or a blood clot have risks when taking estrogen medications.
Different dosage forms of HRT such as patches, vaginal rings, and spray may also carry less risks compared with the pill form. And as the WHI study demonstrated, postmenopausal women have increased risks when taken primarily to prevent chronic conditions such as heart disease.
How do the changes affect certain vaginal products?
One significant change was to remove the warnings from low-dose vaginal estrogen products that are applied directly into the vagina. These products are not substantially absorbed into the bloodstream or body but rather act locally on the genital area to manage vaginal and urinary symptoms. These products can be used during and for years after menopause.
What should you discuss with your doctor if you are having symptoms of menopause?
It is important for you and your doctor to discuss your symptoms and health history to determine the risk and benefits of HRT. An important part of your discussion should focus on when to begin HRT and the expected duration of treatment.
Although HRT is an effective treatment for menopausal symptoms, there are other non-hormonal medications available. Several non-hormonal products have been recently approved for use to manage symptoms of menopause. Be sure to ask your doctor about non-estrogen treatments.
An anticipated outcome of these changes is to encourage doctors and their patients to have a full discussion to select appropriate therapies to manage menopausal symptoms safely based on individual risks.