Here’s why we think a ban is coming. Action Alert!
A National Academies of Sciences, Engineering, and Medicine (NASEM) committee recently released a report regarding compounded pain creams. The report makes clear that, like the FDA, NASEM does not seem to understand the purpose of pharmacy compounding, which is a dire concern as we await another NASEM report assessing the “clinical utility” of compounded bioidentical hormones. We fear that the upcoming NASEM report will give the FDA cover to ban compounded bioidentical hormones like estriol. We must make the FDA and NASEM listen to consumers who rely on these medicines.
The NASEM report’s conclusion demonstrates that NASEM, like the FDA, doesn’t understand compounding:
There is limited evidence to support the use of compounded topical pain creams to treat pain conditions in the general adult population. The few APIs [active pharmaceutical ingredients] that show potential effectiveness in compounded topical pain creams…are already available in FDA-approved topical products used to treat pain.
Please note that what NASEM regards as potentially effective excludes CBD oil and other supplements, not to mention many drugs that have not been formally approved for this use.
The NASEM committee then concluded that the “lack of evidence regarding systemic absorption of ingredients used in compounded topical pain creams gives rise to a substantial public health concern that requires “additional oversight” by the government. Our translation: all topical pain creams should be FDA-approved, which means that the producers must be willing to spend billions of dollars to gain approval, which will in turn mean that only patentable drugs will be available.
The existence of FDA-approved versions of medicines used by compounding pharmacies is not relevant to the need for compounded medications. Compounding pharmacies make customized, natural medicines for patients for whom it is difficult to swallow a pill (the elderly, children, and patients with disabilities, for example), as well as for patients with allergies, sensitivities to environmental contaminants and preservatives, or who require doses or delivery systems different than those of commercially available products. The whole point is that many patients, for a variety of reasons, cannot take FDA-approved versions of a medicine, so they need access to different versions of those medicines from compounding pharmacies to stay healthy.
What most concerns us is the fact that the report reads as if it was produced by the FDA, which has demonstrated almost nothing but antipathy towards pharmacy compounding. The fact that NASEM is apparently ignorant of the important role compounded medicines play in patient health does not bode well for the review of estriol and other compounded bioidentical hormones. A NASEM report finding that compounded hormones are unnecessary because there are FDA-approved hormones on the market would give the FDA plenty of cover to issue a ban on these vital medicines.
To briefly recap where we are: estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List; items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. The FDA convened a NASEM committee to study the clinical utility of treating patients with compounded bioidentical hormones; the findings of this committee will be used by the FDA to make a final decision on the fate of estriol and other compounded hormones.
The FDA’s hostility to customized bioidentical hormones has nothing to do with safety. We’ve noted that the FDA acknowledged it hadn’t received any adverse events pertaining to estriol, which shouldn’t come as any surprise: its safety profile is exceptional.
Actually, there is ample clinical evidence to suggest that bioidentical hormones are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”
Other researchers have reached similar conclusions:
Concerning cardiovascular disease, studies by the Postmenopausal Estrogen/Progestin Interventions Group (PEPI) and Gerhard et al demonstrated that natural progesterone does not negatively impact cardiovascular disease progression, unlike synthetic progestins… From the available data, BHRT may prove to be cardioprotective and not increase the risk for breast cancer [emphasis added].
There is evidence, then, that the FDA is poised to eliminate the safer alternatives in compounded bioidentical hormones: remember that there is no FDA-approved estriol product, meaning that an FDA ban on compounded estriol means patients will completely lose access to this critical hormone. We fear that the committee will not even understand the crucial difference between estriol and other estrogens. We must continue to speak out to the FDA, telling them that patients rely on these critical medicines.
Action Alert! Write to the FDA and NASEM, with a copy to Congress, telling them that patients rely on compounded bioidentical hormones like estriol. Please send your message immediately.
MANY WOMEN DEPEND ON THIS.
Estriol is beneficial to women’s health. Please do not ban it.
Do what is right for the health of all creatures. You know what to do.
Please don’t ban these! just because there isn’t sufficient data doesn’t mean they don’t help people. They’re better off taking these compared to pain killers that wreak all kinds of havoc on ones health including creating histamine intolerance and other reactions.
Please continue to let us use compounded medications. For some of us, this is the only way to get relief from painful conditions.
I rely on bio-identical hormones. I have been taking bio-identical hormones for many years and they have been a safe alternative to pharmaceuticals. I use them to ease the symptoms of menopause and benefit my health in general. Thank you for your consideration.
Compounded Estriol is Safe & Effective. I use it for post menopausal issues, providing comfort to me safely. It should continue to be available for p.o people like me.
Hello,
It seems that the government is slowly but surely taking away our freedom to choose healthcare options including now Estriol hormone replacement therapy. It seems that this favors large pharmaceutical companies. Please don’t consider this proposal and reject agencies that try to restrict citizens from healthy alternative choices.
Thank you,
Compounded bioidentical compounds are quality, low cost products that are required.
Keep you damn hand off!!!!!!
Please protect our right and ability to have compounded Bio identical hormones like estriol. Thank you.
Actually, there is ample clinical evidence to suggest that bioidentical hormones are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”
Other researchers have reached similar conclusions:
Concerning cardiovascular disease, studies by the Postmenopausal Estrogen/Progestin Interventions Group (PEPI) and Gerhard et al demonstrated that natural progesterone does not negatively impact cardiovascular disease progression, unlike synthetic progestins… From the available data, BHRT may prove to be cardioprotective and not increase the risk for breast cancer [emphasis added].
There is evidence, then, that the FDA is poised to eliminate the safer alternatives in compounded bioidentical hormones: remember that there is no FDA-approved estriol product, meaning that an FDA ban on compounded estriol means patients will completely lose access to this critical hormone.
I have been using compounded Estriol for two years, and it has made a huge difference in my life. After taking oral Estriol for nearly 10 years, a test revealed that I was not absorbing any of it! But the compounded cream, applied internally, has had great results for me. It is imperative that you interview the people using these compounded hormones and get REAL information before deciding that they are going to be banned! WE NEED THESE COMPOUNDS!
I oppose any FDA restriction on physician prescribed, pharmacy compounded pain creams and bioidentical hormone creams.
Please don’t take our natural remedies away from us. Estriol is a good thing. Let us have this simple pleasure, this simple natural health aid. Thank you.
I have a terrible reaction to the “horse derived” hormone medications, (pharmaceuticals like Prempro, etc) but feel much better on my compounded bioidentical hormones, which help me feel more vital, have better memory, due to bio-identical estrogen, and be in better health. Do not ban simply because Big Pharma wants to eliminate this source of competition. I thought the USA is for freedom not for monopolies! Especially when studies show there is less risk of hormone -related cancers than with the pharmaceutical forms of estrogen. Please support the science and don’t take away my effective hormone cream. Kathleen Ervin
I have been using compounded hormones for several years.
Traditional medications did not get results and compounded work extremely well and cont imagine my life without them. Since not covered by insurance I must pay hundreds of dollars each month but the benefit is worth the sacrifice. Honestly too sad everyone can’t have the advantage of these products -rather than take them away from consumers try extending availability to many others !!!
Among other things, CBD oil takes away my pain for hours at a time and has none of the hallucinogenic or even debilitating problems that marijuana has. It is my daily go to since my (not my fault) auto accident of over a year ago.
The FDA is just another corrupt government agency. Inconsistent in its work and this is ALL ABOUT MONEY!
AMEN TO THAT SISTER!
Sadly the FDA and NASEM are blatantly protecting pharmaceutical companies by focusing on regulating compounded bioidentical hormones (e.g., estriol) when patients rely on them with positive AND NO ADVERSE AFFECTS. If there was no reason for a patient to rely on estriol, there would be no issue. But since there is no FDA-approved estiol product, the compounded medicine fills a crucial role. The FDA should be grateful for a compounded medicine helping people who are in need of this hormone. Throwing commercial requirements onto bioidentical hormones is not a service to the public or the individuals needing to use the medicine. Let’s get our priorities straight and care more for the people. Thank you.
I depend on my compounded hormones such as estriol to keep me feeling healthy, as do many of my friends. Removing access to them would cause an uprising against the FDA and the government. We know that this action, among others
would be a gift to Big Pharma, and will be publicized in the negative terms it deserves.
I am so glad to have estriol available because it protects me from having another UTI. When you are over menopause you no longer have female hormones to protect you from unwary tract infections.
Yes, I so agree. What a relief!
I do not trust the FDA, They approved opioids without proper testing, a compromised analysis using degraded placebo, many sides effects and safety issues. Would you want the FDA to approve your vaccine or to deny approval of medicinal that works. II do not understand why the AMA and FDA does not open up to alternative medicine. Could it havre something to do with Greed, Power, Big Pharma Money?
I have MS and take bioidentical hormones since I had to have an oophorectomy (removal of ovary because of previously having cervical cancer), and had enlarged ovary, and born with only 1 ovary. Bioidentical hormones help keep hot flashes which would make my MS worse. Thanks for letting you know about this.
I use compounded bioidentical Estriol because I get relief from health issues I have and have no side effects. These products are safe and effective, much more so than synthetic or animal derived medications. Pharmaceutical hormone products increase the risk for breast cancer and cardiovascular disease. They are NOT safe. Please don’t take natural medications away from us. It’s hard to believe that we even have to ask for that. Compounded medications are safe. There are many of us who for one reason or another don’t do well with pharmaceutical hormones or pharmaceutical drugs in general. Don’t take the option to use natural products away. It’s the only way many of us can stay healthy.
Do not take natural hormones away. Woman need them, especially now.
Dear FDA and NASEM,
Just FYI – there are millions of middle aged, post-menopausal women (like me) who cannot use prescription hormones because of the risk of cancer. The only safe alternative for us is a bioidentical hormone. I have personally used a bioidentical hormone cream (Pro-Balance Plus) for years, under the advisement of my OB-Gyn, MD, to eliminate post menopausal symptoms. If this cream were banned by the FDA, myself as well as millions of women would face a severely reduced quality of life. I find it hard to believe that any women working for the FDA would do that to a fellow sister. Are there only men working for the FDA? I implore you to reconsider the ban on bioidentical hormones. For many of us, it is our only choice in living a happy normal life. Furthermore, this appears to be a blatant attack designed to support increasing the already obscene amounts of profit in big pharma. This makes one curious as to the actual motivations of the FDA individuals promoting this attack on our well being.
Please do not support any bans on compounding any hormonal treatment. Estriol is one of the hormones I need in my compounded medication to be normal, energetic and not a burden on others. I rely on compounded medications as part of my overall health choices.
The FDA, NASEM, USP and drug manufacturers are all sleeping in the same bed. The goal is to steer al business into the hands of a few greedy players which is the problem with other healthcare entities. Businessmen are destroying healthcare in order to line their pockets without providing care.
Compounding pharmacies provide medicines to people who cannot tolerate traditional medicines…………..Without compounding medicines I would barely be able to function.
Compounded bioidentical hormones have given me back my life……..they are safe & effective !
I have been on BHRT for 22 years, after a surgical menopause. First year on Premarin made me very ill.
To Whom It May Concern…
I use bio-identical hormones. They are VERY important to those of us that use them. You must research and understand that there is a difference between estriol and other estrogens.They are a safe alternative to the bad ones. I implore you to not ban these. I cannot take the others and I would suffer greatly without bio-identicals.
Mia P
We depend on these products to feel better and improve our overall health.
I use estriol and have done my research based on my doctor’s advice. I am monitored for safe hormone levels on a regular basis. I do not wish to see this substance banned.
I’m a 27 year breast cancer survivor. After 14 years of kyjelly for the dry vaginal issues I was able to get vaginal suppositories that greatly improved my sex lift & marriage. I do yearly exams & pay attention to all of my compounding meds.
Not sure how I could address these health issues without compounded estriol. It is made especially for my needs. Why would we eliminate a proven way for better health solutions.
I’ve had no cancer reoccurrence during the past 13 years. I need compounded estriol to maintain my vaginal health issues.
Concerning cardiovascular disease, studies by the Postmenopausal Estrogen/Progestin Interventions Group (PEPI) and Gerhard et al demonstrated that natural progesterone does not negatively impact cardiovascular disease progression, unlike synthetic progestins… From the available data, BHRT may prove to be cardioprotective and not increase the risk for breast cancer [emphasis added].
It is sad that you must be asked to attend to this. Patients rely on hormones like estriol.
The Effects of Compounded Bioidentical Transdermal Hormone Therapy on Hemostatic, Inflammatory, Immune Factors; Cardiovascular Biomarkers; Quality-Of-Life Measures; And Health Outcomes in Perimenopausal and Postmenopausal Women
Subjects receiving compounded transdermal bioidentical hormone therapy showed significant favorable changes in: Greene Climacteric Scale scores, Hamilton Anxiety Scale, Hamilton Depression Scale, Visual Analog Pain Scale, fasting glucose, fasting triglycerides, MMP-9, C-reactive Protein, fibrinogen, Factor VII, Factor VIII, Insulin-Like Growth Factor 1, and health outcomes of co-morbidities and a number of prescribed medications. Antithrombin III levels were significantly decreased at 36 months. All other measures did not exhibit significant effects. Administration of compounded transdermal bioidentical hormone therapy in doses targeted to physiologic reference ranges administered in a daily dose significantly relieved menopausal symptoms in peri/postmenopausal women. Cardiovascular biomarkers, inflammatory factors, immune signaling factors, and health outcomes were favorably impacted, despite very high life stress, and home and work strain in study subjects. The therapy did not adversely alter the net prothrombotic potential, and there were no associated adverse events. This model of care warrants consideration as an effective and safe clinical therapy for peri/postmenopausal women especially in populations with high perceived stress and a history of stressful life events prior to, or during the menopausal transition.
I’ve been using these BioIdentical Hormones for several years. They are if GREAT benefit to my well being & my health. They are so benign wits absurd for anyone to try & make them unavailable!! It’s merely because they cannot get a patent on them because they are made from plants!! This is “Big Brother” finally coming to pass. Lord save us from those who are trying to save us!!
Jo Ellen Doering
Patients rely on compounded bioidentical hormones like estriol.
The possible FDA ban on compounded estriol means patients will completely lose access to this critical hormone.
I have been using compounded bio identical hormones for the past 35 years. I use tri_est which includes estriol. My health is excellent, I take NO pharmaceutical drugs.I am now 73 and banning these supplements would be deleterious to my health. Please read the research.
I rely on compounded bioidentical hormones like estriol. Please do not limit my access to them as they greatly improve my health and well being.
How do I send my message? When I click on Take Action I can’t edit the message or address it.
Hi Diana,
Thank you for your support. You should be able to add your own message onto the existing petition. You won’t be able to change the recipients though, as we have to set that beforehand.
Going to my compounding pharmacy for my hormone replacement therapy has kept my alive and sane!
THANK YOU!!!!!!!!! I have a FB page devoted to al of this with many followers and I do a great deal of volunteering for Dr. David Rosensweet, a participant as you know — anything we can do please please please let me know.
My nae is Carolyne Shapiro – I am in Los Angeles and if you like I will send you the link to my cBHRT Washington FB page. I have been heavily involved in all of this the past six years and to have my hormones taken away is a huge No!!!!!
We soooo appreciate you and all it is you do for us and we are trying too to do well by you!!!!
Hi Carolyne,
Thank you for your support! We would love for you to email the Facebook link to [email protected]. Stay safe!
Dear Folks:
Please do not ban estriol. It is safe, beneficial and needed. Surely you yourself or other family members can benefit from it emmensely.
Thank you!
Phil Roberts, MD, MS, ABAARM
Dear FDA and NASEM, Please be aware that estriol is a critical hormone for many, many women. It has been proven SAFER than any other form of estrogen. It is used in Europe in women who have a history of breast cancer as it decreases the risk of recurrence. It is extremely effective applied topically or vaginally for vaginal atrophy. Bioidentical topical hormones are safer and more effective than synthetic hormones and those derived from animals and do not increase risk of thromboembolic events, proven by multiple studies, and in fact may be cardioprotective according to available data. Data also shows they may be protective against breast cancer. As a user and prescriber of estriol and other bioidentical hormones I am well aware of the negative effects not having estriol and other bioidentical hormones would have on the women of our country. Their physical and mental health would suffer tremendously and their costs for compensatory medications would increase. It is critical that you keep these safe and effective products available.
Patients rely on compounded bioidentical hormones like estriol!!
Patients rely on compounded bioidentical hormones like estriol!
This is outrageous. Everyone is not a One Size Fits All. Some people have needs that make it necessary to compound!
There is evidence, then, that the FDA is poised to eliminate the safer alternatives in compounded bioidentical hormones: remember that there is no FDA-approved estriol product, meaning that an FDA ban on compounded estriol means patients will completely lose access to this critical hormone. We fear that the committee will not even understand the crucial difference between estriol and other estrogens. We must continue to speak out to the FDA, telling them that patients rely on these critical medicines.
I take compounded bioidentical hormones! do not ban them!
I am using estriol cream after have all my reproductive organs removed 4 yrs ago. I haven’t had any menopausal symptoms. I don’t want to take anything synthetic.
Compounded medicines should be approved for the general use of all medicines that require it. This includes Estriol. Estriol is a bioidentical hormone that the body recognizes as it’s own. It is a much safer medicine than synthetic hormones derived from female horse urine which is proven to increase cancer in post-menopausal women. The lack of estrogen causes many diseases and conditions that disable women. “there is ample clinical evidence to suggest that bioidentical hormones are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”
Other researchers have reached similar conclusions:
Concerning cardiovascular disease, studies by the Postmenopausal Estrogen/Progestin Interventions Group (PEPI) and Gerhard et al demonstrated that natural progesterone does not negatively impact cardiovascular disease progression, unlike synthetic progestins… From the available data, BHRT may prove to be cardioprotective and not increase the risk of breast cancer.
Beyond that many people rely on compounded medicine due to allergies to patent medicines that can lead to fatalities. Children and women are over-dosed because the amount of active ingredients is based on a larger MALE dosage. This can permanently ruin their health and deadly
Our government must not ban compound medicines. We want to maintain high-quality healthcare and medicine as compared to all the other major countries in the world.
Do not ban estriol. It’s crucial for my menopausal health.. I’ve used compounded estrogens for years. No horse urine products for me.
It would be malicious to ban compounded bioidentical hormones like estriol. Many patients rely on it for treatment.
I use homeopathic medicine to fight cancer and pain and I feel most of the medication is safer than prescribed drugs whose side effects are often worse than the a ailment.
The FDA and NASEM need to go back school to learn about bioidentical hormones. I have been taking the cream or estriol capsule for years with absolutely no side effects. I wouldn’t be able to function with out it. The FDA and NASEM need to listen to the patients instead of trying to get an FDA approved Estriol product so the drug companies can make more money. I personally will not buy a FDA approved Estriol product….I will go without!
I have been using compounded bioidentical hormones for many years. They are a much safer alternative to hormones derived from pregnant mare’s urine. It troubles me that the compounded hormones that have proven to be so beneficial in my life may no longer be available to me and many others….with no thanks to the FDA.
I am a 60yr old disabled nurse and I have many health issues all caused by Drs negligence. I have biotoxin illness and it wiped out all my hormones production and I also carry the MTHFR gene and I can’t detox heavy metals or chemicals as drugs are and all others and I had ovarian cancer 5 yrs ago. I had my hormones rechecked and I needed supplementation and I CAN NOT USE PHARMACY DRUGS bc I can’t break down chemicals or estrogen in my liver and I have high estrogen and can’t bring it down and I use a natural progesterone item and my Dr also put me on compounded testosterone cream and I’ve been using it for two years and my level has come up as did my progesterone. If YOU REMOVE MY ABILITY to HAVE IT MADE then I will become hormone deficient….YET AGAIN! I will NOT use regular pharmacy drugs bc I couldn’t even lift my head out if the bed until I stopped all drugs and statrted natural healing and us8ng COMPOUNDED cream. My heart is just fine thanks sonstop worrying about me or anyone else reguarding health issues you think may happen bc they are not and we need and deserve FREEDOM of choice.
As a patient (also an RN) using both pain and hormone replacement creams via compounding pharmacy, I find that the FDA & NASEM are behaving dispicably in trying to disallow such prescriptions developed for me personally, prescribed by my physician who knows and understands my best options for health and safety. Stop the masquerade of pretending to protect the public; we know this is patent, pharmaceutical, and profit driven. I pray that your corruption be exposed.
I rely on these meds
Many people with sensitivities and allergies to certain ingredients, harsh preservatives in many drugs LIKE ME need their medicines or HRT cream compounded biodentically. Less ingredients are obviously better tolerated too. Estriol is known to be safer, not as strong, less or no side effects, and gentler than other estrogens.and more identical to a woman’s body, rather than products like Premarin (pregnant mare urine).,which is disgusting, incompatible, let alone the horrible abuse that is done to horses.
I am a Family Nurse Practitioner and I work with menopausal women. Compounded bio-identical hormone replacement is at the core of my practice and it is very safe. In addition Big Pharma pills “One size fits all” does not work for most women who need to adjust up or down the dosage that compounded preparations provide.
My patients and I rely on these critical medicines, that are compounded to their needs.
To the FDA, I have been using BHRT for 16 years.
Do not take away compounded estriol or progesterone
or any other forms of bioidentical hormone replacement
that my ObGyn has safely prescribed for me following
a hysterectomy 16 years ago.
This is very scary to me! I HAVE to use a compounded bi-est cream of estriol/estradiol because of SEVERE gynecological issues brought on by menopause. My M.D. prescribes them, and they have saved my life! I have to have the estriol in combination with estradiol. It does not work any other way for me! I have tried animal-derived and synthetic hormones – they do not work for me! I suffered for two years before I started with the compounded hormone cream individually designed for me, and if that is taken from me, my health will decline tremendously. I have been on these creams for 11 years. They are natural and safe. Please do not take these from us! This would be devastating to my quality of life! I’m actually not sure how I could function.
For 30 years i have benefitted from compounded bioidentical hormones. At 72 I am active and mentally, physically and emotionally healthy. Twice yearly my physician reviews my health and runs lab tests to make certain I am healthy and responding well to this hormone therapy. It is essential that we have a choice in our health care and in the therapies offered. My compounding pharmacies have been extremely helpful and careful in their services.
I am an award-winning investigative medical journalist who has researched bio-identical hormones for the past 18 years. After reading and analyzing countless studies over the years, I became convinced of their merit and went on them myself to experiment in 2005. My entire health improved and my physiology did a positive 360 turnaround. Using a combination of bio-identical estrogen, progesterone and testosterone, I was able to turn my osteoporosis around, lower my cholesterol, improve my heart rate and other physiological improvements Today it is 15 years later and I’m still taking them and my health is better now at age 67 than it was at age 50 before I began taking BHRT. The only difference is now I look 50 whereas then I looked 67. My meticulous research and interviews with doctors as well as patients proves the merit of BHRT in reversing serious diseases while promoting good health and alleviating the devastating disruptive conditions of andropause and menopause for millions of men and women. My research also shows that the drug companies issue false propaganda to the FDA that is designed to remove BHRT because it threatens their trillions of profits. Freedom of choice is a basic tenet of democracy and patients have the right to choose BHRT which has been proven safe since widely used across Europe since the 1930s.
I can identify with your results, but not your method. Yes, I too have researched the subject from Dr. John R. Lee M.D. ( deceased) to my current and long time doctor and confidant Theresa Dale Ph.D., N.D. whose entire adult life has been dedicated to the subject in her book, ” Revitalize Your Hormones”. Do you get the difference? Replacing is not part of the program, and her over 20 years of research has the recommendations as to why, NOT. You will find that other M.D. s approve, too; but I know other allopaths will not go along with saliva testing which is superior to blood sampling.
They are losing money, the end…
I have used compounded hormone therapies for over 15 years. I would be horrified if this was taken away. I have relied on these prescriptions and have been helped immeasurably by them. I see no reason whatsoever for this ban to take place. Please take into consideration how long these compounds have been in favorable use. Honestly, leave them be.
Compounded bio-identical estrogen and progesterone cream is essential to the well being of post menopausal women. I have been using it since I became menopausal at age 52. I had a DEXA that year and lo and behold, I found I was osteoporotic. Over the years, I have moved to osteopenic and finally my DEXA at the age of 72 was normal (no standard deviations from the norm).
Please make sure that these compounded hormones remain available to us.
Thank you!
Leave compounding along. And get you had out of the pocket of the Patent Drug Lords.
All pharmacy and medical organizations need to join together to fight FDA in the courts.
I rely on my compounded BHRT. It is good for me, effective remedy for good health.
DO NOT take it away!!
Every menopausal women should be on natural biodentical hormone replacement. This is of utmost importance for those of us who use estriol cream along with natural progesterone cream. We do not want to use synthetics as they may cause cancer!! Please keep our cream available
Patients rely on compounded bioidentical hormones like estriol. Please do not remove them. Compounding pharmacies make customized, natural medicines for patients for whom it is difficult to swallow a pill (the elderly, children, and patients with disabilities, for example), as well as for patients with allergies, sensitivities to environmental contaminants and preservatives, or who require doses or delivery systems different than those of commercially available products. An FDA ban on compounded estriol means patients will completely lose access to this critical hormone! Plus there is ample clinical evidence to suggest that bioidentical hormones are safer than the alternatives.
Thanks for this!
I used to sell HRTs(hormone replacement therapies) for BristolMyers Squibb.
I sold yam-based 17-estradiol when I was 25-30 and obviously too young to need for menopause.
When I hit 52 I had a very easy menopause…. like no issues EXCEPT for vaginal atrophy that made sex impossible!
– so I tried Estrace by BMS because I knew about it…. Rx by my doc…… oh my goodness, I felt like I was on drugs!!!! I after 2 days I became ill, sick.
– frightened, I tried an ‘organic’ topical cream – no effect
– frustrated I tried various oral estrogens…. spent a week in the bathroom
– saw s new OB/GYN who Rx’ed Compounded Estriol….. I thought it was going to be terrible but after 3 applications I was Fine!
Corrected!
Able to have a normal intimate experience …. like night and day it just Worked!
– no side effects at all….felt fine!
If Estriol is not allowed any longer there will be many women like myself (you know, young looking, hot, who like sex and whose partners do) who won’t live a normal life.
Taking this away would be gender discrimination…..
Imagine someone saying Viagra would no longer be available?!?
The roar would be deafening.
Same with (compounded) Estriol.
Keep Estriol forever available and indeed, let more women experience the benefits.
Please stop banning of estriol, it is important for women’s health. It has been very beneficial for the quality of life for woman. It has been very safe. It is not the public asking for this ban. Please remember that estiriol could also be a product that your own family members would want and need.
From the available data, BHRT may prove to be cardioprotective and not increase the risk for breast cancer
As a physician, I have been prescribing estriol/estradiol as the main source of estrogen to women for 15 or more years. This, in combination with natural micronized progesterone as opposed to a synthetic progestin. Amongst the thousands women who I have prescribed this treatment to, how many cases of breast cancer or DVT do you think I have observed? ZERO!!! It may be coincidence, but the odds are heavily stacked against that.
With all we know from scientific publication about estriol – its preferential activation of the anti-proliferative beta estrogen receptor in the breast; its regulatory breaking effect of the overall estrogen action, we absolutely NEED/MUST HAVE estriol to safeguard women from any negative effect from estrogen restoration.
An FDA ban on compounded estriol means patients will completely lose access to this critical hormone!
FDA IS SO CORRUPTED FROM POLITICS AND THE REVOLVING DOORS WITH BIG PHARMA THAT IT HAS RUN THE COSTS OF THE MEDICAL SYSTEM SKYHIGH WITH CHRONICALLY ILL PEOPLE. FDA ONLY REGULATES 11 INGREDIENTS IN PRODUCTS WE APPLY TO OUR SKIN WHEN EUROPE REGULATES OVER 1000. IT IS SHAMEFUL THAT FDA WORKS CONSTANTLY AGAINST COMPOUNDING INDUSTRIES AND EVERYBODY KNOWS THIS IS CORRUPTED END RESULTS OF BIG PHARMA SPENDING MORE THAN 2 TIMES THE FOSSIL FUEL INDUSTRY DOES ON POLITICAL LOBBYING. THE COMPOUNDING PHARMACIES HAVE THE POTENTIAL TO HELP THE DISABLED PEOPLE, BUT FDA AND MEDICARE WON’T LET THEM STOP THE SUFFERING FROM LOW QUALITY OF LIFE. DISABLED PEOPLE HAVE GREAT NUMBERS OF ALLERGIES AND INTOLERANCES TO TOXINS THAT DO NOT ALWAYS CAUSE EFFECTS IN PERHAPS HALF OF THE POPULATION FROM LACTOSE, PROPYL GLYCOL, STEARATES, FRUCTOSE, ALUMINUM, MERCURY, AND OTHER CHEMICALS BECAUSE THEY HAVE LOOPHOLES TO STOP ANY INSURANCE COVERAGE FOR COMPOUNDING PHARMACIES TO MAKE DRUGS WITHOUT THE TOXIC INERT (A LIE) INGREDIENTS. THERE IS WIDESPREAD HORMONE DISRUPTION FROM THE FAILURE OF ALL OF OUR NATIONAL PROTECTION AGENCIES WHO NO LONGER PROTECT ANYBODY EXCEPT PROFITS OF BIG CORPORATIONS, AND ESTRIOL AND OTHER BIOIDENTICAL HORMONES COULD RESTORE THE BALANCE. BIOIDENTICAL HORMONES ARE CURRENTLY KEEPING THE WOMEN OF RICH MEN LOOKING YOUNG AND STRENGTHENING THEIR LIBIDOS. IT IS LONG OVERDUE TO REMOVE ALL THE RESTRICTIONS ON COMPOUNDING PHARMACIES BEYOND LABELING QUALITY CONTROL AND REGULATIONS INVOLVING SAFETY AND ENVIRONMENTAL GOOD.
I have been on bio identical hormone therapy for 25 years, and I can honestly say it has changed my life! Not only has it improved my quality of life, It has improved my bone dentistry, mental clarity, & mental health. I feel compounded bio identical hormone therapy is a much safer option then taking synthetic hormones. Studies have proven synthetic estrogen has many side affects and puts women at a higher risk for breast cancer.
Patients rely on compounded bioidentical hormones like estriol.
Please do not ban bioidentical hormones such as estriol. My sister has used this for years with great results.
I rely on compounded bioidentical hormones.
Many Americans rely on the use of Bio-identical hormone cremes to prevent age-related diseases from developing and/or progressing and to have vitality for activities of daily living. I experience unpleasant side effect with many traditional prescriptions and welcome continued access to alternatives that make me feel better and stay independent longer. I have been using bio-identical hormones for years and plan to do so for the remainder of my life because they are better than the synthetic versions. Please keep the natural forms of estrogen, progesterone and other hormones that our bodies once made available to those that need these hormones to remain healthy and active.
Please do NOT eliminate compounded bioidentical hormones like estriol, patients rely on these CRITICAL medications.
With a history of cancer, ERT from big Pharma is not an option for me. I’ve been advised by my surgeons and most of my AMA type doctors! And the progestin cream from horse urine is not bioidentical PLUS it’s horrendously expensive. In addition, in case you didn’t know, the accompanying literature for Prempro and others says you cannot use it safely for more than a year! What are you supposed to do then? The bioidentical compounded estriol cream is safe, cheap, and effective. And that is why big Pharma is opposing it. When you want the truth, follow the money.
I use estriol.
It is a natural product.
WHAT COULD BE THE EXCUSE FOR A BAN!!
The FDA is recognized by the general public as whores to Big Pharma. It’s never about the health or well-being of the consumer — it’s always about fixing things to help Big Pharma, for which most of the sleazy whores at the FDA will work after their retirement from “government service.”
YOU ARE SUPPOSED TO BE SERVING THE PUBLIC, not screwing the public and helping Big Pharma for your own benefit.
THE FDA IS TOTALLY CORRUPT and the public is starting to realize this.
FIX YOURSELVES before you are TOTALLY REVAMPED.
As long as you help Big Pharma rape the public, our health care system will be under constant scutiny for major reform and part of any successful reform will be the TOTAL REFORM OF THE CORRUPT and WHORED-OUT FDA!!
If you don’t want to eventually get fired, clean yourselves up!!
THE PUBLIC IS ON TO YOU!!
Do not interfere with my families ability and right to get these critical medicines.
BUTT OUT OF OUR LIVES NOW. Focus on the pharmaceuticals that are KILLING people, not this.
Do not act as the pharmacies hench men trying stamp out the competition.
we are not stupid
FDA acknowledged it hadn’t received any adverse events pertaining to estriol, which shouldn’t come as any surprise: its safety profile is exceptional.People and their doctors should be allowed to the freedom to obtain customized medicine. After all, no two bodies are alike, nor to they metabolize many substances the same way.
Agreed….THE FDA DOES NOT PROTECT THE INTEREST OF THE PEOPLE….OBVIOUSLY THIS IS A PLOY TO FURTHER CONTROL THE PUBLIC W PHARMA DRUGS. I am 52 years old. I don’t take, won’t take and NEVER intend to take pharma DRUGS. That is what is offered as YOUR Gold Standard of care – DRUGS. Myself and many others will not be controlled by the pharma INDUSTRY and will only ever use natural products which the FDA continues year after year to remove for the NATURAL world and try to control, dictate and manipulate. More MOMMY STATE BS. I loath your greed and control tactics. We the people trust BIG PHARMA less and less minute by minute. I don’t buy your “healthcare system” either. The FDA maintains a “poorcare system”. Get out of our bodies and out of the way.
Leave this up to patients and their medical provider to decide what is best for them. Women need all options available for their medical health providers to decide what is best.
I have been taking compounded bioidentical hormones, including estriol (one of the three components of estrogen) and progesterone, for over twenty years, and they have saved my life. Estriol, progesterone, and other bioidentical hormones are important and vital because these compounded products are the EXACT CHEMICALS my body used to produce on its own. Menopause was terrible, and caused severe problems for me, both mental and physical. Bioidentical hormones restored my health and well-being. There have been instances over the last twenty years when I couldn’t get my prescription. Every time this happened, menopause symptoms returned just as severe as ever. I can’t emphasize how important these compounded products are to me, and countless other women. The pharmaceutical substitutes are not the same product as the compounded hormones, and therefore I cannot take them. There is NO SUBSTITUTE for these safe compounded bioidentical hormones.
I don’t want to think about how life would be turned upside down for me without these important safe compounded products. I also don’t understand why you would even consider taking such important safe products off the market! It’s very upsetting to me and incomprehensible. Please, realize how important these compounded hormones are for so many people and how much we will all be negatively impacted if they were to be taken off the market. And why would you do that???
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