Exciting News for Women & Men!

FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products.

FDA issues class-wide labeling changes for testosterone products for middle-aged and older men.

For my first post I am thrilled to unveil these revolutionary insights that will change lives for both women and men!

First, the good news for women, and their partners.... for those partners of women experiencing menopausal symptoms, you understand what I mean.

HALLELUJAH! Joy to Women Around the World!

FDA Initiates Removal of “Black Box” Warnings from

Menopausal Hormone Replacement Therapy Products

The History of Hormone Replacement Therapy

Menopausal hormone therapy (MHT) origin dates to the 1800’s in Germany using animal derived hormones therapy. The result were successful in reducing menopausal symptoms (Kohn G, 2019).

The Evolution into Menopausal Neglect

Hormone replacement therapy (HRT) gained greater use in the 1960s providing relief for millions of women worldwide. Clinical HRT trials for postmenopausal symptoms started in the US in 1998 resulting in what we now know as the Women’s Health Initiative Study (WHI). The study was designed to evaluate common causes of death and disability in postmenopausal women, such as cardiovascular disease, cancer, and osteoporosis. The WHI trial, was inadequately designed, evaluated, and reported. Participants were of older age, treated with synthetic hormones (conjugated estrogen and progestins) and use of now outdated hormone protocols such as unopposed estrogen in women with a uterus (Cagnacci A, 2019).

The WHI is now referred by some as the largest, most expensive travesties in modern medical research, resulting in irreversible health debility and suffering among postmenopausal women nationally and internationally (Payerchin, 2025).

What We Know Now

After reviewing 30 trials which included 26,708 women participants found HRT was not associated with increased cancer mortality. Quite the contrary, finding that women who started HRT before age 60 appear to have a decreased mortality risk.

Evidence showed that starting HRT within ten years of the onset of menopause can have many benefits outweighing potential risks. Benefits include a reduced risk of all-cause mortality and fractures. HRT has also been associated with 50% reduction in heart attack risk, 64% reduction in cognitive decline, and 35% lower risk of Alzheimer’s (FDA Health & Human Resources, 2025).

Exciting News for Older Women!

For older women beyond 10 years of menopausal onset, it was determined hormone therapy to be a safe option to relieve menopausal symptoms such as hot flashes, urogenital symptoms and sexual dysfunction.

A large-scale study including records from 10 million senior Medicare women between 2007 and 2020 among patients aged over 65 years.

Based on the extensive study, The Menopause Society stated age alone should not lead to women stopping HT use. Additionally, the statement expressed support for women continuing to use HT for hot flash management with adequate counseling and risk assessment (Krewson, 2024).

The decision to initiate or continue HRT in women 10 years beyond menopause onset or over age 65 should be a joint decision between patient and provider taking into consideration the dose, type and route of hormone therapy as well as risk benefit profile.

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For the Men, You Have Not Been Forgotten

FDA issues class-wide labeling changes for testosterone

products for middle-aged and older men.

In response to the TRAVERSE study FDA issues class-wide labeling changes for testosterone products for middle-aged and older men.

 The Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events, and Efficacy Response in Hypogonadal Men clinical trial, but easier said, the TRAVERSE study, was a multicentered, randomized double-blind, placebo-controlled, noninferiority trial which included 5246 middle aged men. The average therapy and follow-up was between 2 and 3 years duration. Inclusion criteria were men with confirmed hypogonadism having serial serum testosterone level < 300ng/dl and symptomatic hypogonadism. Transdermal testosterone gel daily therapy was used with dose adjustments to maintain therapeutic levels of testosterone between 350-750ng/dl.

The TRAVERSE study sought to determine the effects of testosterone replacement therapy (TRT) on the incidence of cardiovascular events (CVE) in middle-aged men (45-80 yrs.) who either was at high risk or had pre-existing cardiovascular disease as defined in Figure 1.

Risk Factor Inclusion for TRAVERSE Study

Figure 1

CARDIOVASCULAR DISEASE	INCREASED CARDIOVASCULAR RISK
·       coronary artery disease	·       hypertension
·       cerebrovascular disease	·       dyslipidemia
·       peripheral artery disease	·       current smoking
	·       stage 3 chronic kidney disease
	·       diabetes
	·       high sensitive CRP
	·       Age =/>65 yrs o
	·       coronary calcium score > 75th% for age and race

DETERMINATION and FINDINGS

A SIDE NOTE

Prostate cancer occurred in 12 of 2,601 patients in the treatment TRT group and 11 of 2,603 in the placebo group. Meaning there was essentially no difference in rates of prostate cancer between the group treated with testosterone gel and the untreated group (Lincoff A.M., 2023).                                                                                                                                                

I am so delighted that the FDA has released the TRAVERSE study findings and redacted the previous “Black Box” warnings that therapy could lead to increased risk for adverse cardiovascular outcomes. Be aware with the good news of the removal of the CV risk profile, there has been a cautionary new warning added. There is new labeling for testosterone products regarding a risk for increased blood pressure and urging caution when using testosterone products for low testosterone due to aging (Monastra, 2025). This concern is primarily related to the risk for elevated blood pressure which can be more concerning in older men.

As not to get too technical, let me try to simplify this concept. The increase in blood pressure is in part related to “polycythemia” (increased in red blood cells with thickening of the blood) and its associated mechanism which can result in fluid retention and increased intravascular pressure. As an older man blood vessels are prone to be more fragile or weak and are likely to already have some degree of atherosclerosis or “clogged arteries,” this thickening of the blood could increase the risk for clots and restricted blood flow to vital organs.

CONSIDERATIONS

But might I add, this is not an all-inclusive study of the risk factors that could potentially be associated with all forms of TRT such as injectable testosterone usually in the form of testosterone cypionate, or pellet therapy as a bioidentical. These forms of therapy have their own set of considerations and risk such as potential polycythemia or increased estrogen levels just to mention a few.

INSIGHTS

In adding my personal insights as a provider of testosterone therapy for greater than 10 years, I would like to point out a few considerations. It is common practice among hormone therapy, anti-aging practices to exceed normal physiologic testosterone levels. In doing so, it is necessary to prescribe anastrozole or clomiphene to lower estrogen levels and have men donate blood due to polycythemia induced by their excess in testosterone. Along with the positive effects testosterone therapy can offer, you also get the adverse effects that can be health altering or even life threatening.

Let’s get real!!! Does this sound like healthy aging? This is not optimum therapy.

Peak testosterone producing years for males are between the ages of 20s-30s with unadulterated testosterone levels on average between 400ng/dl to less than 600 ng/dl.

Beyond certain medical conditions, did you ever know of any virulent young man needing to donate blood or take estrogen blockers???

All forms of TRT can be utilized safely if dosed, administered and monitored properly along with proper routine health screenings.

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Whether you are a female experiencing hormone related symptoms due to cycle irregularities, pre-menopause, post-menopause symptoms or a male experiencing signs of low testosterone such as changes in libido, reduction in muscle mass, feelings of apathy,  it is imperative to work with a provider who has your current and long-term health in mind and is knowledgeable of any existing health conditions you may have.

Let’s not try to be something we never were. Let’s live well.

Take Care! Until Next Time.

For more detailed information, see articles below.

Bibliography

Cagnacci A, V. M. (2019, September 18). The Contraversial History of Hormone Replacement Therapy. Medicina, 55(9), 602.

FDA Health & Human Resources. (2025, November 10). FACT SHEET: FDA initaites Removal of Black Box Warning from Menopause Hormoanl Replacement Therapy. Retrieved from US Department of Health & Human Resources: https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html

Kohn GE, R. K. (2019, May 27). The History of Estrogen Therapy. Retrieved from PubMed: https://pmc.ncbi.nlm.nih.gov/articles/PMC7334883/#:~:text=Menopausal%20hormone%20therapy%20(MHT)%20has,Papanicolaou.

Krewson, C. (2024, April 24). Hormone therapy safety: Study finds potential benefits for senior women. Retrieved from Contemporary OB/GYN: https://www.contemporaryobgyn.net/view/hormone-therapy-safety-study-finds-potential-benefits-for-senior-women#:~:text=A%20recent%20large%2Dscale%20study,Statement%20by%20The%20Menopause%20Society.

Lincoff A.M., e. a. (2023, June 16). Cardiovascular Safety of Testisterone-Replacement Therapy. The New England Journal of Medicine, 389(2), pp. 107-117. Retrieved from Research Summary: https://www.nejm.org/do/10.1056/NEJMdo007128/full/

Monastra, M. (2025, March 03). FDA recommends remving black box warning for CV risk form all testosterone product labels. Retrieved from Healio: https://www.healio.com/news/endocrinology/20250303/fda-recommends-removing-black-box-warning-for-cv-risk-from-all-testosterone-product-labels#:~:text=The%20FDA%20has%20issued%20a,of%20postmarket%20ambulatory%20BP%20studies.

Payerchin, R. (2025, November 10). Medical Economics. Retrieved from Medical News: https://www.medicaleconomics.com/view/fda-ending-black-box-warning-for-hormone-replacement-therapy-for-women