
For over two decades, following a study run by the Women’s Health Initiative (WHI) regarding the role of estrogen and progestin in women, the FDA placed a black box warning on Hormone Replacement Therapy (HRT) products for menopause, noting risk of cardiovascular disease, breast cancer and dementia.
As a result, many women avoided HRT even when experiencing menopausal symptoms like hot flashes, night sweats, sleep disruption, brain fog, joint pain and vaginal dryness. There has been a lot of controversy since the study, but updated evidence has resulted in the FDA issuing this change. Removal of the black box label does not mean that HRT is risk free. Risk depends on various factors that should be discussed with a women’s health practitioner, who understand your personal health and family history, and is able to look at your personal journey with menopause and how it’s affected you, factors like age, timing of initiation, medication formulation, dose, and more.
The decision to use HRT remains a shared decision between the patient and the practitioner. Just as there are risks, there are potential benefits to HRT to consider that include relief of menopausal symptoms that have disrupted your day to day, cognitive and mood support from estrogen, prevention or slowing down of bone loss, and improvement of heart health with respect to cholesterol balance, vascular function, and blood vessel flexibility. HRT has also been known to improve vaginal tissue and elasticity health. Improved joint health and overall skin health are also connected to HRT. We encourage you to educate yourself, discuss with professionals and others you trust, and advocate for yourself for optimum health. If you have questions, or need a doctor to fit your needs, feel free to contact us for help.
Reference:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations





