Wednesday, July 17, 2024

Fda Approved Bioidentical Hormone Replacement

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Bioidentical Hormone Replacement Therapy: It is not just for women!

As people age, their bodies experience a decline in the levels of various hormones. These hormones are estrogen, testosterone, and progesterone. The drop in the level of these hormones can cause certain symptoms.

Some of the common effects of reduced hormones that are common among woman who are in their post menopause phase are the following:

  • Floggy thinking
  • Loss of muscle mass

Hormone therapy is the treatment for these conditions as it replaces the hormones. After using hormone therapy, hormone levels rise, and symptoms improve as well.

Recommendations from national societies and medical experts state that people should consider the benefits and risks of both bioidentical and conventional hormones. Your physician can share with you the available options and guide you on what to use depending on what you prefer.

Compounded Hormones Versus Manufactured Hormones

The use of the compounded hormones is very common in the U.S. by women in menopause. The North American Menopause Society reports that about 1.4 million women are using this treatment. NAMS notes that is 40% of all prescriptions for hormone therapy in women who are in menopause. Personally, I use both compounded and conventional. I use an estradiol patch, which is amazing for hot flashes, and I add to that a combination of progesterone and estriol cream. I use a separate cream for testosterone.

Here are some things to consider when you are making your decision as a prescriber whether to write for compounded or conventional manufactured hormones:

  • In many instances compounded hormones are more affordable. Estradiol vaginal cream can cost well over $300 while compounded estradiol vaginal cream may start at around $50.
  • Some insurance companies may be more likely to cover FDA approved hormones. However, now some compounding pharmacies file insurance too.
  • Compounding hormones allow the prescriber to order any strengh of the hormone he or she wants for the patient.
  • Compounding allows providers to order more than one hormone in a combination. For example, estrogen can be combined with progesterone and even androgens too if desired.
  • Compounding can be useful for patients who are allergic to an additive in a manufactured medication.
  • For some patients a sustained-release form of estrogen such as a patch or pellet may be more effective for severe vasomotor symptoms or migraines.
  • Donna Locke: Fda Wants To Restrict Compounded Bioidentical Hormones

    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.

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    Push Away From Conventional Therapies

    To some degree, every one of the 21 current and former CBHT users in this study expressed distrust and frustration with the mainstream medical approach to managing menopause. Many framed their use of CBHT in terms of an express desire to avoid conventional hormonal approaches based on three key themes: fear and uncertainty about the safety of conventional HT a strong aversion to conjugated estrogens in particular, and and overarching distrust of a medical system that they perceived to be dismissive of their concerns and overly reliant on pharmaceuticals in place of greater clinical attention.

    Fear and uncertainty about the safety of HT

    Seventeen of the 21 current or former CBHT users described their treatment decision within the context of fear or uncertainty about the safety of conventional hormone therapy. Like those in the overall study, many women choosing CBHT were concerned about the safety of HT, and WHI results confirmed those fears. Susan, a 56-year-old professor who sought CBHT from her gynecologist for a short period of time when she started experiencing more intense and more frequent hot flashes, put it this way:

    Like other women in this study, Susan suggests that she was never inclined to seek out conventional HT to manage menopausal symptoms, and media coverage of conventional HT reinforced this belief.

    Distaste for conjugated estrogens, in particular

    LISA: So, whats the difference between them?

    Distrust of biomedicine and the pharmaceutical industry

    What Are The Side Effects Of Bioidentical Hormones

    Pin on Health

    When the FDA approves a drug, the drug company must report any side effects they are told about. These side effects are included in the paperwork you get when you pick your medication up at the pharmacy. Pharmacies that compound hormones do not have to report drug side effects to the FDA or provide paperwork. This contributes to the myth that compounded hormones are safer when healthcare providers don’t know all of the possible side effects of these hormones.

    Side effects can occur, especially after the first dose. Your body is not used to the new level of hormones. Many side effects get better as the body adjusts to the new level of hormones. In some cases, the dose may need to be changed.

    Some common side effects of bioidentical hormones include:

    You may itch or get red around the area where you apply your hormones if you use a patch, cream or gel.

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    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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    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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    How Bijuva Works To Help Ease Hot Flashes

    Bijuva works by replacing a womans natural hormones with bioidentical ones.

    The estradiol helps reduce hot flashes, while the progesterone lowers a womans risk for endometrial cancer.

    The medicine should only be used by women who havent had their uterus removed surgically. If you dont have a uterus , you dont need to take progesterone.

    Bijuva is taken once every evening with food.

    Claim : Salivary Testing Should Be Used To Providepersonalized Therapy

    Facts About Bioidentical Hormone Therapy

    With the publication of the results of the WHI HT trial in 2002, the risks and benefits attributed to a specific formulation of estrogen and progestin were defined. The stark contrast between the observational data and the findings of the randomized, controlled clinical trial led to the recommendation that, in addition to advising that women be informed of the risks and benefits of HT, the lowest possible dose of hormone should be used to treat symptoms for the shortest period .33 These findings were thought to be generalizable to all available hormone preparations.

    Proponents of CBHT claim that customized compounded formulations provide the best means of tailoring or personalizing therapy. They recommend salivary hormone testing to guide therapeutic decisions for the determination of dosages. In its recent position statement on HT, the North American Menopause Society endorsed the use of the clinical end point of symptom relief to guide dosing.34

    Individualization in dosing and delivery methods is also possible with FDA-approved BHT and nonbioidentical HT because many dosages and delivery methods are available.

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    Types & Routes Of Estrogen

    In a meta-analysis of 24 trials of menopausal estrogen in 3329 postmenopausal women, the frequency of hot flashes decreased by 75% in those using estrogen. Estradiol and conjugated estrogen , appeared to be equally effective for the treatment of hot flashes. These doses eliminate hot flashes completely in approximately 80 percent of women.

    The preferred estrogen is estradiol. Estradiol is the estrogen that is identical to the one the ovary makes throughout reproductive life .Estradiol can be given by mouth, skin patch, or vaginal ring. The other form of estrogen that we do not typically use in our practice is conjugated estrogen –it is synthetic.

    Estrogen patch â Many experts now prefer treating women with the estradiol patch rather than estrogen pills . A combination estrogen and progestin patch is also available. Some patches need to be replaced every few days, while others are only replaced once a week. At Hearthside Medicine, we tend to offer non-oral estrogen .

    Estrogen patches work as well as estrogen pills to increase bone density and treat menopausal symptoms. Women with a uterus who use an estrogen patch must also take a progestin to decrease the risk of uterine cancer. The patch should be placed on the lower abdomen and changed 1-2 twice weekly , providing steady levels of estrogen throughout the day and night.

    Estrogen pill

    Oral estrogen can also increase the risk of gallbladder disease.

    Estrogen Cream:

    Estrogen Gel:

    Estrogen Spray:

    Estradiol Troches:

    Claim : Compounding Provides Improved Delivery And Tolerability Of Ht

    Compounded medications require a written prescription from a licensed physician. Prescriptions filled in a compounding pharmacy are prepared, mixed, and assembled according to the specifications of the prescriber. Compounding plays an important role in providing drugs to meet the individualized needs of patients that cannot be met by a commercially available FDA-approved preparation. It may provide a different strength, dose, or delivery system, or it may allow a medication that is otherwise poorly tolerated to be essentially reformulated and delivered in an alternative form .28,29 Compounded hormone preparations are not required to undergo the rigorous safety and efficacy studies required of FDA-approved HT and can demonstrate wide variation in active and inactive ingredients.5

    The oversight of accredited compounding pharmacies falls to state pharmacy boards, which are to direct the method of preparation and enforce standards for compounding as dictated by the US Pharmacopeia. Thus, most compounded products do not have scientifically rigorous clinical testing for either safety or efficacy.5,30 A limited FDA survey in 2001 analyzed 29 product samples from 12 compounding pharmacies. None of the products failed identity testing however, 10 of the 29 failed 1 or more quality test, and 9 of the 10 failing products also failed potency or assay testing. For FDA-approved therapies, the usual comparison failure rate is less than 2%.28

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    Are Testosterone Products For Women Approved By The Fda

    While the hormone testosterone has been linked with raising female libido, preventing bone fractures and breaks and elevating mood, women considering the use of testosterone patches, rings, and creams should proceed with extreme caution. Read on to learn more about what women should be aware of before using testosterone products.

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    Clinical Trials On Bijuva For Treatment Of Hot Flashes

    Bioidentical Hormones for Menopausal Therapy

    Researchers analyzed Bijuva in a large study known as the pivotal REPLENISH trial.

    Results of this trial, published in June 2017 in the journal Maturitas, which included 1,835 menopausal women, showed Bijuva significantly reduced hot flashes and lowered the risk of a potentially precancerous condition known as endometrial hyperplasia.

    This is the first randomized clinical trial of a bioidentical 17B-estradiol and progesterone, in one single oral capsule that has shown a significant reduction in moderate-to-severe hot flashes in postmenopausal women with a uterus, while reducing the risk to the endometrium, which is the lining of the uterus, said Kagan.

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    Safety And Efficacy Of Cbht

    Data on the safety and efficacy of CBHT is limited. With some exceptions , medical and scientific consensus generally holds that bioidentical hormones likely have the same risks and benefits as conventional hormones . At the same time, these and other authors raise concerns particular to CBHTmost notably, the potential for exposure to higher doses of estrogen than necessary for symptom control, inadequate doses of progesterone required to protect against endometrial cell proliferation due to inconsistencies in the quality of compounded pharmaceuticals, and the use of serum or salivary hormone testing to determine dosage . In general, the medical community recommends FDA-approved HT over CBHT to ensure product quality, and recommends that hormone regimens be clinically tailored to comply with FDA recommendations for using the lowest dose needed to achieve treatment goals .

    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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    Claim : Compounded Bht Is Safer Than Fda

    Proponents of CBHT claim that compounded products containing plant-derived hormones that are bioidentical to those found in the human ovary offer better safety, efficacy, and tolerability than noncompounded, FDA-approved HT.23 Unfortunately, these claims have led to confusion among patients, who often look to their physicians for direction. Therefore, physicians who care for women seeking relief from menopausal symptoms need to be familiar with the claims made about custom CBHT products and the evidence in the medical literature on their effectiveness or the lack thereof.

    Objective evidence and scientific studies to substantiate these claims are lacking, and the use of custom CBHT vs FDA-approved HT remains a topic of ongoing debate in the lay press, in alternative medicine literature, and in the popular media.15 The claim that the safety profile of bioidentical compounds is better than that of FDA-approved HT15 belies the complexities of the topic. Both CBHT and FDA-approved HT are available in various dosages, combinations, preparations, and routes of delivery that may have differing effects on risk to an individual patient.26

    What Are The Symptoms Of Menopause

    The Facts about Bioidentical Hormone Replacement Therapy with Dr. Neal Secrist

    Every womans period will stop at menopause. Some women may not have any other symptoms at all. As you near menopause, you may have:

    • Changes in your periodtime between periods or flow may be different.
    • Hot flashes getting warm in the face, neck, or chest, with and without sweating.
    • Night sweats that may lead to problems sleeping and feeling tired, stressed, or tense.
    • Thinning of your bones, which may lead to loss of height and bone breaks .

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    What Is Hormone Therapy For Menopause

    Lower hormone levels in menopause may lead to hot flashes, vaginal dryness, and thin bones. To help with these problems, women may be prescribed estrogen or estrogen with progestin . Like all medicines, hormone therapy has benefits and risks. Talk to your doctor, nurse, or pharmacist about hormone therapy. If you decide to use hormone therapy, use it at the lowest dose that helps. Also use hormones for the shortest time that you need them.

    Menopause Symptoms Impact Health And Work

    Menopause symptoms arent limited to hot flashes and night sweats. Other symptoms of menopause include difficulty sleeping, difficulty concentrating, mood swings, depression, headaches, racing heart, vaginal dryness, decreased recent memory and decreased energy. For some women, these symptoms begin years before menopause.

    Hot flashes are uncomfortable, but they are also related to other issues. Hot flashes can disrupt sleep and may cause mood changes, difficulty concentrating, and impairment of short-term memory. In one study, frequent hot flashes and night sweats were associated with a 50% increased risk of cardiovascular disease. And, if these hot flashes and night sweats persisted over time, then there was a 77% increased risk of later cardiovascular disease.

    Given the health and career impact of menopause symptoms, its a problem that many clinicians are not well-informed on the current thinking regarding hormone therapy. Bluming explains that part of the problem stems from the fact that menopause education is currently offered to less than 25% of residents studying obstetrics/gynecology. This may also explain why some practitioners still refuse to prescribe hormones. Given that over 50 million women in the United States are over the average age of menopause , one would think menopause care would be a higher priority.

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