FDA Initiates Removal of “Black Box” Warnings from HRT
Big news today from Washington, D.C.! I was honored to be in the room at the Health and Human Services (HHS) office this morning for a significant development for women’s health. The FDA has officially removed the boxed warning from virtually all forms of menopausal hormone therapy (MHT). These warnings, which stemmed from the flawed interpretation of the Women’s Health Initiative study, have previously led to a dramatic decrease in the use of hormone therapy, to the significant detriment of women’s bone health in or approaching menopause.
Estrogen is a potent mediator of bone turnover and contributor to bone density and strength (for both men and women). Loss of estrogen leads to increased osteoclast activity and rapid bone loss, particularly in the late peri- and early postmenopausal periods. In fact, before the approval of the bisphosphonate category of bone medications, estrogen was the primary treatment for osteoporosis.
We now have a generation of women, myself included, who missed out on this bone-preserving intervention plus estrogen’s cardiovascular, genitourinary, and vasomotor benefits. It’s frustrating, but at least now we can move forward in a more positive manner.
Estrogen is not a panacea. The bone benefits are lost rapidly after stopping treatment, and even with treatment, most women will eventually progress to osteopenia and many to osteoporosis. MHT delays but is typically not enough to prevent osteopenia and osteoporosis.
Our goal at Osteoboost Health is for women to be able to maintain their bone strength and stay fracture-free as long as they live. This is a tall order. millions of fractures to prevent for the 50
% of all women who are now fracturing. This approach will be multidisciplinary, incorporating nutrition, exercise, novel clinically proven non-drug interventions such as Osteoboost, and, when indicated and recommended by one’s physician, hormones and/or prescription bone-active medications. We are committed to this goal. Whatever it takes.
https://pmc.ncbi.nlm.nih.gov/articles/PMC10721581/#:~:text=Lees%20et%20al.,better%20bleeding%20profiles%20%5B35%5D.
