FDA Removes Black Box Warning on HRT, Re-evaluating Testosterone Benefits for Women
TL;DR
- The FDA's removal of the black box warning on HRT signifies a shift towards recognizing its benefits, including reduced risks of all-cause mortality, fractures, heart attacks, and cognitive decline, particularly for women transitioning through menopause.
- Testosterone, when administered at physiological doses via transdermal or injectable methods, does not significantly negatively impact HDL cholesterol in women, unlike oral testosterone which can reduce it.
- Testosterone replacement therapy in women, even at doses used in clinical practice, can increase lean mass and improve aerobic capacity, suggesting benefits beyond just muscle building.
- The FDA's black box warning removal on HRT is crucial because it combats the fear and limited use of these therapies that stemmed from the Women's Health Initiative, allowing for a re-evaluation of scientific data.
- Testosterone's benefits extend beyond muscle mass, impacting sex drive, energy levels, and lean mass maintenance, with receptors present throughout the body, not just in muscle tissue.
- Hormone replacement therapy, including estrogen, progesterone, and testosterone, can significantly improve sleep, bone health, brain function, and overall quality of life for women experiencing perimenopause and menopause.
- Testosterone can mask underlying conditions like pernicious anemia by increasing red blood cell production, highlighting the importance of comprehensive blood work beyond just hormone levels.
Deep Dive
The FDA's removal of the black box warning on Hormone Replacement Therapy (HRT) for menopause signifies a paradigm shift in women's health, acknowledging significant benefits that were previously overshadowed by fear. This change encourages a re-evaluation of HRT, including testosterone, as vital tools for improving women's health outcomes across multiple domains, from cardiovascular and cognitive function to lean muscle mass and energy levels.
The implications of this re-evaluation extend beyond menopause. While historically testosterone has been viewed primarily through a male lens, its importance for women is increasingly recognized. Studies, such as a 2020 randomized controlled trial in the British Journal of Sports Medicine, demonstrate that even at doses considered physiological for women (e.g., 10mg daily cream), testosterone can lead to significant improvements in aerobic capacity, lean mass, and muscle fiber type, without causing virilization. This suggests that testosterone therapy for women can enhance physical performance and body composition, challenging the notion that it is solely for muscle-building and reframing it as a crucial component of overall health and vitality. Furthermore, the benefits of HRT, including estrogen and progesterone, extend to cognitive health, with a notable reduction in the risk of Alzheimer's disease, likely due to estrogen's role in brain function and its potential synergistic effect with improved insulin sensitivity from exercise, which HRT can encourage.
The removal of the black box warning, largely driven by a re-evaluation of data from initiatives like the Women's Health Initiative, allows for a more nuanced understanding of HRT's risk-benefit profile. Contraindications remain, such as active breast cancer or uninvestigated vaginal bleeding, but for eligible individuals, the benefits are substantial. These include reduced all-cause mortality, a 50% reduction in heart attack risk, and a 64% reduction in cognitive decline. This updated perspective on HRT, particularly testosterone, is critical for addressing age-related decline in muscle mass and function, often misattributed to aging alone, and for empowering women to optimize their health proactively rather than simply treating disease.
Action Items
- Audit hormone testing protocols: Specify liquid chromatography mass spec for testosterone measurement in 5-10 patient cases.
- Implement patient education: Draft 3-5 talking points on testosterone benefits and risks for women, addressing virilization concerns.
- Track hormone level changes: For 3-5 patients starting HRT, monitor hemoglobin and hematocrit at 4-week intervals.
- Evaluate DHEA supplementation: For 2-3 patients on testosterone therapy, assess DHEA levels and consider supplementation if decreased.
Key Quotes
"the fda just removed the black box warning on hrt for menopause who should not go on hormone replacement therapy active breast cancer or active cancers if someone has not worked up vaginal bleeding and stroke benefits of hormone replacement therapy include a reduced risk of all cause mortality fractures hrts also been associated with a 50 reduction in heart attack risk 64 reduction in cognitive decline 34 lower risk of alzheimer's"
Dr. Gabrielle Lyon explains that the FDA's removal of the black box warning on hormone replacement therapy (HRT) for menopause is significant. She highlights that HRT offers substantial benefits, including reduced risks of all-cause mortality, fractures, heart attacks, and cognitive decline, including Alzheimer's disease. Lyon specifies that individuals with active breast cancer, uninvestigated vaginal bleeding, or a history of stroke are generally advised against HRT.
"we think about testosterone and we think about muscle mass but there are testosterone receptors all over the body there are estrogen receptors all over the body it's not just oh my gosh i'm going to give you testosterone and then you're going to grow a beard and muscles it's not going to happen"
Dr. Gabrielle Lyon clarifies that testosterone and estrogen receptors are present throughout the body, not just in areas associated with typical male or female secondary sex characteristics. Lyon argues against the common misconception that administering testosterone to women will inevitably lead to undesirable side effects like beard growth or excessive muscle development, suggesting these fears are often overblown.
"the gold standard is liquid chromatography okay um just thought i'd throw that out so if you're getting is that specific like so should that be something when you go to your physician you request yes it should okay yes it should liquid chromatography that's right and you should at least find out is it liquid chromatography mass spec"
Dr. Gabrielle Lyon emphasizes the importance of specific laboratory testing for hormone levels. Lyon recommends that patients request "liquid chromatography mass spec" testing for testosterone when consulting with their physicians, identifying it as the gold standard for accurate measurement. This highlights a key detail for individuals seeking precise hormone level assessment.
"androgens you know they are also precursors for estrogens estrone estradiol and estriol e3 in pregnancy but the primary most well known androgen of them all is testosterone that's right which can aromatize into estrodial in both men and women"
Dr. Gabrielle Lyon explains the relationship between androgens and estrogens in the body. Lyon notes that androgens, including testosterone, serve as precursors for various estrogens. She clarifies that testosterone, the most recognized androgen, can convert into estradiol in both men and women, underscoring the interconnectedness of these hormone pathways.
"so so there's no concern that would be a like a a much higher dose right where you start seeing those the biggest concern is virilization if we dose testosterone which is very it is highly androgenic meaning testosterone is androgenic meaning it will affect it can affect virilization hair growth clitoral enlargement at higher doses versus and we're not going to talk about this in too much detail other anabolic agents like nandrolone which is an anabolic steroid which is fda approved for anemia of chronic disease"
Dr. Gabrielle Lyon addresses concerns about testosterone dosage and its potential side effects, particularly virilization in women. Lyon states that virilization, characterized by symptoms like hair growth and clitoral enlargement, is primarily a risk at supra-physiological doses. She contrasts testosterone with other anabolic agents like nandrolone, which has different approved clinical uses and properties.
"and then we have muscle building and anabolic agents in the other corner and these agents are things like uh nandrolone and oxandrolone oxandrolone also known as anavar which is not typically used anymore but was used back in the day and i talked about this for burn victims and maintaining lean mass and muscle"
Dr. Gabrielle Lyon distinguishes between hormone replacement therapy and anabolic agents used for muscle building. Lyon identifies nandrolone and oxandrolone (Anavar) as examples of anabolic agents, noting that oxandrolone was historically used for burn victims to help maintain lean mass. This distinction is important for understanding the different applications and classifications of these substances.
Resources
External Resources
Books
- "The Forever Strong Playbook" by Dr. Gabrielle Lyon - Mentioned as a roadmap for building strength, including workouts, recipes, recovery strategies, and mindset tools.
Articles & Papers
- "The effects of moderately increased testosterone concentration on physical performance in young women" (British Journal of Sports Medicine, 2020) - Discussed as a randomized control trial examining the impact of daily testosterone cream on physical performance, lean mass, and muscle fibers in young women.
People
- Dr. Gabrielle Lyon - Host of "The Dr. Gabrielle Lyon Show," author of "The Forever Strong Playbook," and advocate for muscle-centric medicine.
- Dr. Nick Buringer - Guest on the podcast, discussing hormone replacement therapy, testosterone use, and related research.
Organizations & Institutions
- FDA (Food and Drug Administration) - Mentioned for removing the black box warning on HRT and for its role in approving medications.
- Women's Health Initiative (WHI) - Referenced as a study that led to fear and reduced use of hormone replacement therapy.
Websites & Online Resources
- bodyhealth.com - Sponsor, offering Perfect Amino supplements.
- manukora.com/DRLYON - Sponsor, offering Manuka honey.
- boncharge.com - Sponsor, offering light therapy and blue light blocking products.
- fromourplace.com/DRLYON - Sponsor, offering toxin-free cookware.
- drgabriellelyon.com/playbook/ - Link for pre-ordering "The Forever Strong Playbook."
- foreverstrong.supercast.com - Subscription service for ad-free episodes and exclusive content.
- drgabriellelyon.com/new-patient-inquiry/ - Link for applying to become a patient.
- institute-for-muscle-centric-medicine.ck.page - Link for joining a weekly newsletter.
- amazon.com/exec/obidos/ASIN/1668085623 - Link for pre-ordering Dr. Lyon's new book.
- x.com/drgabriellelyon - Dr. Gabrielle Lyon's X (Twitter) account.
- instagram.com/drgabriellelyon - Dr. Gabrielle Lyon's Instagram account.
- tiktok.com/@drgabriellelyon - Dr. Gabrielle Lyon's TikTok account.
- facebook.com/doctorgabriellelyon - Dr. Gabrielle Lyon's Facebook account.
- youtube.com/@DrGabrielleLyon - Dr. Gabrielle Lyon's YouTube channel.
Other Resources
- Hormone Replacement Therapy (HRT) - Discussed in relation to the FDA removing its black box warning and its benefits for women's health.
- Testosterone - Discussed as a hormone important for both men and women, its role in muscle mass, energy, sex drive, and potential benefits and risks.
- Estrogen - Mentioned as important for both men and women, with receptors throughout the body, and its role in bone and brain function.
- Progesterone - Mentioned as a hormone that can aid sleep in women.
- Androgens - Defined as steroid hormones related to male sex characteristics but present in both sexes, with testosterone being the primary one.
- Virilization - Defined as the development of male characteristics due to androgen exposure.
- Hematocrit - Defined as a blood test referring to oxygen-carrying capacity.
- Liquid Chromatography Mass Spectrometry (LC-MS) - Discussed as the gold standard for testing hormone levels like testosterone.
- Anabolic Resistance - Mentioned as a change occurring in the mid-30s where muscles become less responsive to protein signals.
- Sarcopenia - Defined as the loss of muscle mass and function, considered dangerous and not just a disease of aging.
- DHEA (Dehydroepiandrosterone) - Discussed as a dietary supplement that can be used to increase estradiol and testosterone levels, potentially with anti-inflammatory effects.