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Fda Approved Bioidentical Hormones 2021

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Coronary Heart Disease And Cardiovascular Mortality

Bioidentical Hormone Therapy Mayo Clinic Womens Health Clinic

Based on data from the intervention phase of the WHI, women aged 50 to 79 years in the overall cohort on oCEE + MPA had increased risk of CHD, defined as non-fatal myocardial infarction and coronary death, compared to placebo, whereas women on oCEE alone had neutral CHD outcomes. Sub-analysis from the WHI showed that age made a difference in CHD outcomes, supporting the timing hypothesis. In the oCEE arm, women aged 50 to 59 trended toward decreased risk of CHD compared to women aged 70 to 79 . Follow up at 13 years supported prior data from the intervention phase of WHI that women who started oCEE alone at a younger age had lower CHD risk. In contrast, those randomized to oCEE + MPA at least 20 years after menopause had significantly higher risk of CHD compared to placebo .

Importantly, cumulative follow up at 18 years showed no difference in cardiovascular mortality between the oCEE + MPA or oCEE group versus placebo for women age 50 to 79 years . Furthermore, there was no significant difference in CVD mortality when groups were stratified by age . Potential explanations for why the intervention phase of the WHI showed unexpected cardiovascular effects include the older study population , mean time since menopause of at least 12 years, numerous women with CV risk factors prior to enrollment, higher hormonal doses compared to subsequent studies and many participants who did not have vasomotor symptoms .

Hormone type, formulation and route

Fda: Bioidenticals Are Public Health Concern Ban Likely

The agency has latched onto this false conclusion from a report it commissioned, and it is another direct threat to estriol and compounded bioidentical hormones future. Action Alert!

The FDAs announcement regarding bioidentical hormones came just hours after the National Academy of Sciences, Engineering, and Medicine released their report reviewing the clinical utility of compounded bioidentical hormone therapy . Because the report views the widespread use of cBHT as a public health concern, the FDA will likely move fast to ban these critical medicines. It is imperative that we mobilize a strong grassroot response to meet this threat and save access to estriol and other compounded hormones.

To quote the FDAs announcement on the report release: Given the lack of high-quality clinical evidence and minimal oversight of cBHT, NASEM concluded that their wide-spread use poses a public health concern.

This has no factual basis at all. A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones. What seems to be underway is an attempt to create drug company monopolies. The result may be that women may not be able to obtain estriol at all, even though estriol protects against cancer.

Specifically, the committees recommendations include:

Additional Resources On Bioidentical Hormones

For information about compounded hormones or to locate a pharmacy that provides individualized prescriptions, visit the Alliance for Pharmacy Compounding.

American Hormones, Inc., founded by Erika T. Schwartz, M.D., renowned expert in the field of natural hormones, offers concierge medical services, including high-quality pharmaceutical-grade hormones shipped nationwide and internationally. The website has extensive information on bioidentical hormones.

There are also many books that you can consult. My books, The Wisdom of Menopause and Womens Bodies, Womens Wisdom provide in-depth information. I also recommend reading The 30-Day Natural Hormone Plan, by Erika Schwartz, M.D. New Menopausal Years, The Wise Woman Way: Alternative Approaches for Women 3090, by Susun S. Weed and TCM: A Womans Guide to a Trouble-Free Menopause, by Nan Lu, O.M.D., L.Ac., with Ellen Schaplowsky.

Read Also: How Expensive Is Hormone Replacement Therapy

Defining Terms In The Chart: What Do Active Pharmaceutical Ingredient Bioidentical Excipient And Route Of Administration Mean

ACTIVE PHARMACEUTICAL INGREDIENT : the molecule that is active in a product.

EXCIPIENTS: these are binders, coloring, flow agents, and other ingredients mixed in with the API to produce the final product .

BIOIDENTICAL: the structure of the active ingredient of the product is identical to the hormone your body produces. However, the ingredients of a bioidentical product, whether in a compounded version or an FDA-approved product, are all manufactured in a lab. None comes directly from nature or is natural. This idea of natural has long been associated with compounded products but it is a misconception.

COMPOUNDING: the creation of custom drugs using FDA-approved APIs and mixing them with excipients to tailor a remedy to a specific prescription.

ROUTE OF ADMINISTRATION: how the product gets into your body.

ORAL: a product you take by mouth

TRANSDERMAL: a product you apply to your skin

Note: Transdermal estrogen has a safer risk profile than oral estrogen with respect to blood clots, stroke, and cholesterol changes because it does not have the effect on the liver that oral estrogen does. This would be especially pertinent for a woman with a personal or family history of these medical issues.1,2

Even Celebrities Believe In Hormone Therapy

â ï¸?The FDA is trying to take away bioidentical hormones like estradiol ...

Her natural and rich hair may be at least partially based on the bioidentical hormone therapy she has been receiving, something which, according to the article, is also being used by famous names. Billionaire philanthropist Oprah Winfrey, legendary entertainer Madonna, and Oscar-winning actress Angelina Jolie have all used them for reasons such as dealing with the effects of menopause.

Bioidentical hormone replacement therapy to regulate the normal fluctuations of the body may be like a fountain of youth of sorts, maintaining the body and mind at healthy levels, while preventing the aging process by extending the natural development of collagen, keratin and elastin in the skin. These are essential proteins that all play roles in keeping the skin looking youthful.

To understand this a little better, lets briefly examine a womans biology: four major sex hormones are released by the female body: estradiol peaks in the first half of the menstrual cycle of a woman which may lead to a spike in progesterone following ovulation. Testosterone is produced by the adrenal glands and ovaries. Finally, the most abundant sex hormone released during younger years, dehydroepiandrosterone is tied to energy levels as well as total health. Levels of these hormones all waver throughout life as a person ages.

Read Also: How To Get More Estrogen In Your Body

Do Bioidentical Hormones Cause Weight Gain

Yes, weight gain is a side effect of bioidentical hormones.

A note from Cleveland Clinic

Bioidentical hormones are used to help people manage symptoms of menopause or other hormonal imbalances. The FDA does not approve some bioidentical hormones. All hormone replacement therapy comes with risks. Compounded bioidentical hormones may come with more risk because their effects are not well studied. Talk to your healthcare provider about the pros and cons of hormone replacement. Most importantly, know that you do not need to live with unpleasant symptoms of low hormones. Your provider can help safely manage your symptoms.

Last reviewed by a Cleveland Clinic medical professional on 04/15/2022.


Is Bhrt Safe Plus Other Treatments To Consider First

BHRT products have not been proven to be safe or unsafe. Because not enough is known about their long-term efficacy or safety, theyre still considered controversial. Be aware of potential side effects, and know that claims stating BHRT is protective against cancer or heart disease in women has not been validated. If you do decide to use them, do so using the lowest dose that helps and for the shortest time period needed to help reduce the chance for side effects.

How Else Can You Balance Hormones Naturally?

Before considering BHRT, I urge you to make lifestyle changes that are truly natural to see how you feel. Chances are your weight, sleep, mood and energy would greatly improve if you tried some of the following hormone-balancing solutions:

Final Thoughts on Bioidentical Hormone Replacement Therapy

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How Much Does Bioidentical Hormone Replacement Therapy Cost

The cost of bioidentical hormone replacement depends on your specific regimen. For example, several FDA-approved bioidentical hormones, like Estrace, have lower-cost generic versions. Other brand-name-only products, like Bijuva, may be more expensive.

The cost of compounded bioidentical hormones can be even more varied. Thats because pricing can be different from pharmacy to pharmacy, even for a similar product. And compounded medications arent always covered by insurance. So, youll likely need to pay out-of-pocket for your prescription.

Donna Locke: Fda Wants To Restrict Compounded Bioidentical Hormones

Dr. Jackie Thielen – What is compounded bioidentical hormone therapy

Get ready for more government overreach unless the public blocks the Food and Drug Administrations years-long attempt to mostly prohibit compounding pharmacies from making individual, customized bioidentical hormone products.

Who would benefit from this elimination of competition in the hormone-therapy field? Why, that would be the big pharmaceutical manufacturers who make their own bioidentical hormone products. Yes. Big Pharma, which has put so many of us through body-crashing hell. Ill get to that in a minute.

The FDA says the customized compounded products are a public health concern, and points to FDA-commissioned studies that compounding pharmacists and their advocates say are flawed, biased, incomplete studies done by researchers unfamiliar with compounded hormones or even compounding. Some members of the most recent FDA study and review commission were recommended by the FDA and had close ties to large drug manufacturers opposed to compounded hormones, according to the Alliance for Pharmacy Compounding, a member and advocate group, and other sources.

The FDA says the study found minimal oversight of compounded bioidentical hormones, and a lack of good clinical evidence for their usefulness. My friend who ran out of her compounded hormones and had to stick her head in her freezer to relieve the ensuing hot flashes thinks theyre useful.

Recommended Reading: What Vitamins Help With Hormone Balance

Are Bioidentical Hormones Fda Approved

by DonnaWhite | Oct 11, 2019

The quick answer is yes, bioidentical hormones are FDA approved but hold on, this is a very controversial and somewhat complex topic that requires more explanation. Some bioidentical hormones are manufactured by drug companies, are approved by the FDA, and sold in standard doses. On the other hand some bioidentical hormone preparations are made at special pharmacies called compounding pharmacies. These compounded hormones are made on a case-by-case basis for each patient as ordered by licensed prescribers. Since compounded bioidentical hormones are custom-made for each individual patient, they arent approved by the FDA nor are they required to be. However, they do contain FDA approved hormones in the formula.

Fda Approves New Hrt Warning Labels

Warnings Cite Health Risks of Estrogen Products

Jan. 8, 2003 For women, its the closest thing to the final word on hormone replacement therapy . The FDA has asked that all labels on estrogen and estrogen-progestin HRT products be revised to carry a high-level warning.

The new box warning, the highest level of warning information in labeling, will state the increased risks for heart disease, heart attacks, strokes, and breast cancer. The warning also emphasizes that these products are not approved for heart disease prevention.

We have approved all new labeling for Wyeth Pharmaceuticals for Prempro, Premarin, and Premphase, said FDA spokeswoman Pam Winbourne, in a teleconference with reporters. All other manufacturers are being faxed letters asking them to revise their labels in a similar fashion.

We believe that different estrogens and progestins act similarly, and in absence of data otherwise, women need to assume the risk with other estrogens and progestins are similar, said Winbourne. Other studies do show that estrogens and progestins are associated with these same side effects.

The FDA also urges that women take only the lowest doses of estrogens and estrogen-progestin products and for the shortest duration to achieve treatment goals, says Winbourne. Women should regularly discuss with their healthcare providers if they need to continue treatment, she said.

The FDA has also modified two of the approved uses for the products:

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Risks Benefits And Treatment Modalities Of Menopausal Hormone Therapy: Current Concepts

  • 1Department of Internal Medicine, Mayo Clinic, Phoenix, AZ, United States
  • 2Division of Womens Health Internal Medicine, Mayo Clinic, Scottsdale, AZ, United States
  • 3Department of Medicine, Brigham and Womens Hospital and Harvard Medical School, Boston, MA, United States

Menopausal hormone therapy prescribing practices have evolved over the last few decades guided by the changing understanding of the treatments risks and benefits. Since the Womens Health Initiative trial results in 2002, including post-intervention analysis and cumulative 18-year follow up, it has become clear that the risks of HT are low for healthy women less than age 60 or within ten years from menopause. For those who are experiencing bothersome vasomotor symptoms, the benefits are likely to outweigh the risks in view of HTs efficacy for symptom management. HT also has a role in preventing osteoporosis in appropriate candidates for treatment. A comprehensive overview of the types, routes, and formulations of currently available HT, as well as HTs benefits and risks by outcomes of interest are provided to facilitate clinical decision making.

Important Questions To Ask About Menopause Hormone Medicines

BIOIDENTICAL Hormones! They are VASTLY different from Pharmaceutical S ...
  • Are hormones right for me? Why?
  • What are the benefits?
  • What are the serious risks and common side effects?
  • How long should I use hormone therapy?
  • What is the lowest dose that will work for me?
  • Are there any non-hormone medicines that I can take?

Want more information about menopause? Check the FDA website at:

The drug and risk information in this booklet may change. Check Drugs@FDA for the latest facts on each product listed in this booklet.

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The Benefits And Risks Of Bioidentical Hormone Therapy

As with any health treatment, bioidentical hormones come with benefits and risks. The benefits of FDA-approved bioidentical hormone therapy stem from the nature of their creation. They are created at a molecular level in order to be as close a match as possible for their patients.

On the other hand, since no conclusive study has yet been made, it can’t be concluded that bioidentical hormones are any safer than synthetic hormone replacement therapy. However, bioidentical treatments have been thought to cause the same potential side effects as synthetically manufactured ones. To keep learning about bioidentical hormones, click on alternative menopause treatments.

Bioidentical Hormone Replacement Therapy


Your bodys hormones control most of your basic bodily functions. They serve as an internal communication system between cells throughout the body. They coordinate everything from digestion and growth to your appetite, immune function, mood, and libido. So, when your hormones are out of balance, even slightly, it can have a big impact on your health and well-being.

Often, when peoples hormones drop or become unbalanced, they turn to hormone replacement therapies to ease symptoms. One such therapy, bioidentical hormone replacement therapy , has gotten a lot of attention in recent years. It promises a natural solution to hormone issues. But what exactly is BHRT, and hows it different from other hormone replacement therapies?

Read on to learn all you need to know about BHRT, its benefits and risks, and whether it may be right for you.

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Benefits And Risks Of Menopause Hormone Therapy

Estrogen is the most effective treatment for VMS. Women with an intact uterus require combined progestogen therapy with estrogen for endometrial protection. For those without a uterus, estrogen alone can be used. Since the risk-benefit profile of HT treatment in symptomatic menopausal women is impacted by age, time since menopause and existing comorbidities, shared decision making is critical in determining what HT formulation and route to use and when discontinuation is appropriate . Table 3 summarizes the evidence on risks and benefits of HT.

Table 3 Risk-benefit profile of menopausal hormone therapy.

Are Bioidentical Hormones Safe

Comparing the Second Generation Hormone Therapies | Ask a Prostate Expert, Mark Scholz, MD

The WHI findings highlighted some of the serious risks associated with HRT. Since then, researchers have learned more about its potential benefits and risks.

Today, experts agree that most healthy women who are within 10 years of menopause can benefit from FDA-approved HRT to provide symptom relief. And there are ways to navigate some of these risks, like using the lowest dose for the shortest amount of time, and opting for local vaginal estradiol instead.

Your healthcare provider will weigh the benefits and risks of your specific situation to decide if hormone therapy is right for you.

As mentioned earlier, experts dont recommend compounded hormones. Thats because they havent been evaluated by the FDA. And because theyre made just for you, quality can vary by pharmacy. In fact, the FDA has tested compounded hormones from multiple pharmacies. The results showed hormone strengths ranging from less than 70% to almost 270% of what they should be.

This variability may cause the product to not work as well or cause more side effects. Yet, your healthcare provider may determine that a compounded hormone is right for you. If thats the case, its important to fill your prescription at an accredited compounding pharmacy they trust.

Recommended Reading: How Do I Know If My Hormones Are Changing

Womens Hormones: The Safety Of Bioidentical Hormone Replacement Therapy

The field of hormone replacement therapies, and in particular bioidentical hormone replacement therapy , has received considerable attention in recent years as it may offer a potential natural alternative treatment for hormonal balances affecting both men and women. While BHRT has been most commonly prescribed for the treatment of menopause symptoms, it can also be used to improve symptoms related to cancer treatment, insulin resistance, thyroid disorders, and many other health conditions. The use of this therapeutic method is increasing in popularity as awareness of the natural alternative grows and patient preferences continue to change.

The Benefits of BHRT

Associated Risks

Nonetheless, this class of therapeutics has been tied to side effects with current research showing that hormone replacement therapy in general may increase the risk of certain conditions including blood clots, stroke, heart disease, and breast cancer. Additionally, BHRT therapy has been associated with acne, bloating, weight gain, fatigue, and mood swings as common side effects, which may deter some patients from the treatment. The risks and potential for side effects should be evaluated on an individual basis as they vary among women depending on their health history.

Compounded Bioidentical Hormones and FDA Regulation

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