Menopause Update: FDA to Remove Inaccurate Black Box Warnings on Hormone Replacement Therapy

Big news in the world of menopause! 

Today marks an important day in the field of women’s health: the FDA will be removing the incorrect black box safety warnings from hormone replacement therapy (HRT) treatments used for menopause and perimenopause.

Many providers and researchers have been advocating for this change for years. These warnings previously stated the bioidentical HRT treatments for menopause increased the risk of breast cancer, stroke, cardiac disease, and dementia, all of which have been extensively studied to NOT be the case. This was all based on a research study in 2002, The Women’s Health Initiative, that overstated the risks of HRT and studied an older patient population than those who typically start HRT, typically <60years old. The WHI also studied a form of progesterone that is not typically used. Unfortunately, these previous warnings have led many women to avoid HRT and not seek out help when struggling in the ups and downs of menopause symptoms.

Not only is hormone replacement therapy SAFE for most women, but it can even REDUCE the risk of heart disease, bone fractures, dementia. 

The symptoms of menopause are mainly caused by the fluctuation of hormones and the eventual decline of estrogen, progesterone, and testosterone.

If you are experiencing hot flashes, mood swings, “not feeling like yourself,” fatigue, difficulty sleeping, joint pain, brain fog, muscle aches, weight gain, skin changes, low libido, vaginal dryness or vaginal atrophy, HRT may be a GREAT OPTION to help you feel like yourself again. 

We at TMW are motivated to provide you safe, effective, and up to date medications and treatments throughout your lifespan. We are experienced in HRT and other treatments to help with menopause management. With shared decision making, we can work together to help you be your best self. 

Christina Bonnet, MSN, CNM/WHNP-BC, RN, CLC 

Published Sources: 

https://www.nhlbi.nih.gov/news/2024/researchers-review-findings-and-clinical-messages-womens-health-initiative-30-years-after

https://pmc.ncbi.nlm.nih.gov/articles/PMC3444558/ 

https://jamanetwork.com/journals/jama/fullarticle/206404 

https://pubmed.ncbi.nlm.nih.gov/27028912/