Update! Alternative to Drugs Made with Pregnant Mare’s Urine

Trio of Rescued Premarin Foals. Photo: Vivian Grant Farrell

INTRODUCTION

We are thrilled to release to you here Jane Allin’s update to our popular Alternative to Drugs Made with Pregnant Mare’s Urine. Premarin® started it all in this 50s, and tragically is still being prescribed. But there are alternatives. Many alternatives — more than ever before.

Jane Allin walks you through many of them. However, this is not an exhaustive list.


Alternatives to drugs made with pregnant mare’s urine

Updated on March, 2018 Jane Allin

BY JANE ALLIN

As part of The Horse Fund’s continuing campaign against the manufacture and use of the Premarin® family of drugs – Premarin®, Prempro® and Duavee® – we have compiled a list of alternatives to drugs made with pregnant mare’s urine (conjugated equine estrogens).

We encourage you to go online to further acquaint yourself with the effectiveness and safety of these compounds. There is a wealth of information out there, but beware of false claims and err on the side of caution.

And, as always, please consult with your doctor before you use these or any other alternatives for the relief of menopausal symptoms.

LIFESTYLE CHANGES

Probably the simplest and most natural approach to the treatment of menopause is to adopt a healthy lifestyle in regard to diet, exercise and stress management. Not only will this help alleviate symptoms but the benefits will ensure that you remain healthy now and in the future.

Nutrition: It should go without saying, avoid refined and processed foods, choose more whole foods, fresh fruit, vegetables and complex carbohydrates. Avoid high fat dairy products and meats and supplement these items with healthy fats such as olive oil, nuts, seeds and lean cuts of meat or fish. Additionally, practice portion control and avoid empty calorie foods.

Exercise: Exercise is vital to keeping symptoms in check. Exercise directly affects hormonal activities in the body by raising the level of endorphins, for example, to maintain emotional stability and suppress anxiety. Moreover, the benefits are unsurpassed: maintenance of muscle and joint strength, increased metabolism, reduced weight, improved cardiovascular health, increased cognitive function, maintenance of bone integrity, and the list goes on.

Stress Management: It is a well-known fact that stress induces more severe hot flashes. There are many stress-reduction techniques available to manage the burden of everyday anxiety – rest, relaxation, varied leisure activities, and most importantly self-affirming thoughts to maintain self-image and confidence.

Lifestyle Solutions: Common sense solutions that include dressing in layers, lowering room temperatures, consuming cool drinks, and cutting down on alcohol, caffeine and spicy foods. For those women who are overweight, weight loss can also help.

Give Up Smoking: If you smoke, giving up will help reduce hot flushes and your risk of developing serious health conditions, such as heart disease, stroke and cancer.

NON-HORMONAL THERAPIES FOR SYMPTOMS OF MENOPAUSE

Many women find the risks associated with hormone therapy to be unacceptable and are requesting non-hormonal therapies to manage their hot flash symptoms. There have been numerous reports in the medical literature and general media as to the effectiveness of various over-the-counter agents and prescription drugs in reducing menopausal hot flash symptoms.

A potential confounder in most hot flash trials is the placebo response rate, which in many studies has been reported as between 18 and 40 percent. This is similar to rates found in studies of hormonal agents, but makes it more difficult to ascertain the true effects of therapy on hot flashes.

NON-PRESCRIPTION (NON-HORMONAL) THERAPIES

The exact mechanism of action for many of the non-prescription alternatives is unknown, however several theories have suggested they act as antagonists on estrogen receptors, or alternatively as selective estrogen receptor modifiers (SERMs). Others are thought to relieve stress and anxiety to help with menopausal mood swings, or have mild anti-inflammatory action.

Dietary Phytoestrogens

Phytoestrogens are naturally occurring substances found in fruits, vegetables, and whole grains such as soybeans, alfalfa sprouts, and oilseeds (such as flaxseed).

Epidemiological data suggest that women ingesting high amounts of phytoestrogens and plant-derived diphenolic compounds, which are functionally similar to estradiol (i.e. allow estrogen receptor binding), have less CAD (coronary artery disease) and breast and uterine cancer and fewer vasomotor symptoms compared with those who consume Western diets.

There is some evidence that they have a weak estrogen-like effect that may reduce the intensity and frequency of hot flashes, however much less potent than that of estrogen. Phytoestrogens consist of three main groups: isoflavones, lignans, and coumestans.

Isoflavones (Soy)

Isoflavones, the soy protein-based group, are most potent of the phytoestrogens and have received the most attention. In several randomized controlled trials using soy and placebo, less than half of these trials (45%) showed a significant improvement in symptoms compared to placebo. Where positive effects were shown, the soy reduced hot flashes by 9 to 40 percent in some trials, but others showed no difference compared with placebo.

Breast density does not appear to be affected by soy preparations after 2 years however, women with breast cancer or with a family history of breast cancer should use concentrated isoflavones with caution. Moreover, long term treatment with soy has shown a small risk of endometrial hyperplasia (growth of abnormal cells/precancerous neoplasms) that can lead to endometrial cancer in a small percentage of women.

Genistein, an isoflavone found in low concentrations in soybeans and elevated amounts in certain soy-derived food has attracted scientific interest for its possible benefits in cancer and heart disease prevention as well as reducing menopausal symptoms.

Data suggest that genistein might have a potential preventative role in reducing coronary artery disease. Acting as a natural selective estrogen receptor (ER) modulator, it may also positively affect the cardiovascular system without the harmful estrogenic side effects in breast and uterine tissue. Genistein is available as non-prescription OTC supplements from a variety of manufacturers.

Lignans (Flaxseed)

An example of the lignand group of phytoestrogens is flaxseed. Flaxseed also contains omega-3 and omega-6 fatty acids. Some clinical studies suggest that replacing dietary fats with flaxseed might be effective for patients with milder symptoms. Others say flaxseed does not significantly affect menopause-specific quality of life or hot flash symptoms.

Coumestins (Red Clover)

Red clover belongs to the coumestin group. Several placebo-controlled studies that evaluated the effectiveness of red clover in reducing hot flashes showed a modest reduction in frequency in women administered various amounts of red clover compared to those receiving placebo. There were no adverse effects or safety concerns with short term administration although long-term randomized studies are lacking.

Black Cohosh

Black Cohosh is probably the most studied and most popular herb for treatment of hot flashes. Black cohosh seems to work by supporting and maintaining hormonal levels, which may lessen the severity of hot flashes. Many women report that the herb works well but it isn’t effective for everyone. It has been reported to be well-tolerated with no serious side effects linked to its use, however, its actual efficacy in clinical studies has been inconsistent.

St. John’s Wort

St. John’s wort has been used as a medicinal herb for its antidepressant and anti-inflammatory properties for over 2,000 years. Many studies show that St. John’s wort may help fight mild to moderate depression and anxiety and has fewer side effects than most other prescription antidepressants, such as loss of sex drive.

Because of its positive effects on mood, St. John’s wort has been used to alleviate and naturally remedy PMS symptoms, such as depression, chronic fatigue and hormonal imbalance. Researchers reported that daily treatment with St. John’s wort was more effective than placebo treatment for the most common physical and behavioral symptoms associated with PMS.

Ginko Biloba

Ginko Biloba is typically associated with decreasing the risk of dementia onset, however limited trials have shown no significant difference compared with placebo.

Kava – WARNING

Some studies claim that kava may be an effective option for treating anxiety, stress, and restlessness, for menopausal mood swings as well as sleeping problems but the data is conflicting. There are, however, safety concerns which should preclude its use.

Kava is possibly unsafe when taken orally. Serious illness, including liver damage, has occurred even with short-term use of normal doses. The use of kava for as little as one to three months has resulted in the need for liver transplants, and even death. This was included to warn the reader of the dangers associated with this particular natural alternative.

Dong Quai

Dong quai finds its roots in traditional Chinese medicine. It is thought to reduce hot flashes. Increasing research shows that there may be scientific connections between dong quai’s uses and its claims, but in limited trials there is nothing to attest to its effectiveness to support its use for vasomotor symptoms. Moreover, because it contains coumarins, interactions with warfarin and photosensitization have been reported.

Evening Primrose Oil

EPO contains high levels of gamma-linolenic acid (GLA) and linolenic acid, which are both omega-6 fatty acids, known to reduce inflammation. It is believed to help influence prostaglandin synthesis and help moderate menopausal symptoms. However, it is important to take the correct dosage – if too high, there may be adverse side effects (e.g. abdominal pain, headaches, upset stomach, and nausea).

Ginseng

Ginseng’s primary menopausal benefit is its ability to support vitality and ease stress. Sleep is often interrupted as a result of menopause, especially due to hot flashes. Ginseng may come to the rescue on this front, possibly supporting healthy sleep cycles by aiding relaxation.

Vitamin E

A daily dose of 400 IUs of natural vitamin E (as mixed tocopherols and tocotrienols) can help alleviate symptoms of hot flashes in some menopausal women.

Melatonin

As a woman approaches menopause the levels of estrogen sharply decrease. Melatonin serum levels also decrease. Vasomotor symptoms (i.e. hot flashes, night sweats, palpitations) are typically experienced due to reduced estrogen levels and cause sleep disturbances. It has been found that melatonin and some of its analogs promote sleep. However, there is inconsistency and discrepancy among the large number of reports regarding the degree of efficacy and the clinical significance of these effects.

Amberen

In 2010 a non-hormonal supplement called Amberen, manufactured by Lunada Biomedical, was touted as the next cure-all for relief of menopausal symptoms. Claiming to have a double-blind, placebo-controlled clinical study to back its effectiveness, it contains 100% natural ingredients, all on the FDA’s approved Generally Recognized As Safe (GRAS) list. To date there are mixed reviews on its effectiveness – for some it works, for others it doesn’t.

Using OTC products or eating natural foods that contain these compounds (e.g. phytoestrogens, Vitamin E) are thought to be relatively safe for the most part, but be aware that no substantiated medical studies are available for many of these therapies and most do not have to comply with the stringent safety, quality and manufacturing regulations that govern conventional medicines.

Acupuncture

Several clinical studies have shown that acupuncture can reduce symptoms of menopause. The premise is that serotonin levels rise which can alter the temperature set point in the hypothalamus.

One such trial compared the effectiveness of; (1) shallow acupuncture; (2) electro-acupuncture and; (3) oral estrogen. A significant reduction in hot flushes was found for all three groups of participants although the degree of symptom reduction was largest in the estrogen cohort.

As a word of caution, in some individuals adverse effects can occur with acupuncture. For example; cardiac tamponade (fluid buildup in the pericardium that compresses the heart); pneumothorax (collapsed lung) and; hepatitis.

Reflexology

Reflexology is the application of pressure to areas on the feet, hands and ears. Reflexology is generally relaxing and may be an effective way to alleviate stress.

The theory behind reflexology is that these areas correspond to organs and systems of the body. Proponents believe that pressure applied to these areas affects the organs and benefits the person’s health.

A small randomized study of women aged 45-60 experiencing vasomotor symptoms who were administered either reflexology or non-specific foot massage showed there was a reduction in both groups but no significance between the two groups.

PRESCRIPTION (NON-HORMONAL) THERAPIES

There is also convincing evidence that some prescription drugs which are not licensed for treating menopausal symptoms do in fact alleviate hot flashes and night sweats. These are powerful drugs yet in severe cases some doctors may be willing to prescribe one of these treatments with the patient’s consent.

SSRIs and SNRIs

SSRIs (selective serotonin reuptakes inhibitors) are a group of anti-depressants and anti-obsessive-compulsives. Although their exact mechanism is unknown, SSRIs are believed to ease depression by increasing levels of serotonin in the brain.

Serotonin is one of the chemical messengers (neurotransmitters) that carry signals between brain cells. SSRIs block the reabsorption (reuptake) of serotonin in the brain, making more serotonin available. SSRIs are called selective because they seem to primarily affect serotonin, not other neurotransmitters.

In a similar fashion to SSRIs, SNRIs (serotonin and noepinephrine reuptake inhibitors) block the reabsorption (reuptake) of the neurotransmitters serotonin and norepinephrine in the brain.

SSRIs such as Prozac (fluoxetine) and Paxil (paroxetine) and SNRIs such as Effexor (venlafaxine), Pristiq (desvenlafaxine) and Desryl (trazodone) have shown a risk reduction in hot flashes of 19 to 60 percent compared to placebo depending on the type of SSRI or SNRI, its potency and dosage. Additionally, significant improvements were seen in general, emotional and mental fatigue as well as the occurrence of clinical depression (as expected). The most common side effects include; headache, nausea, insomnia, dry-mouth, dizziness and decreased appetite.

Of note is that Paroxetine/Paxil is sold under the trade name of Brisdelle for the treatment of menopausal hot flashes – the first non-hormonal treatment to be approved by the FDA for hot flashes associated with menopause. The dosage and duration of these medications most appropriate in alleviating hot flashes is unknown; however, regimens using low to moderate dosages seem to be as effective as those using high dosages and have significantly fewer reported adverse effects.

When using an SSRI or SNRI to treat hot flashes and mood, it is prudent to start the medication at a low dosage and increase to effect. Other SSRIs that have undergone clinical testing include; Citalopram (Celexa) and Sertraline (Zoloft).

Gabapentin

Gabapentin is a drug used to control epileptic seizures, shingles and restless leg syndrome that in some studies has shown to be as effective as estrogen in treating symptoms of menopause.

In one trial that compared gabapentin and estrogen head-to-head against a placebo, the women taking gabapentin and estrogen experienced a 71 percent to 72 percent decline in symptoms versus the placebo effect of 54% reduction in hot flashes. The most common side effects of gabapentin are drowsiness, dizziness, and a “spacey” feeling. These effects tend to subside after a month of treatment.

Clonadine (Catapres)

Clonadine acts in the brain to decrease blood pressure. It has a long history of being used for blood pressure control, but it has potentially annoying side effects, such as dry mouth, constipation, drowsiness, or difficulty sleeping. Clonidine, available in pill or patch form, effectively relieves hot flashes in some women but is completely ineffective in others.

Osphena

Touted as the new female Viagra, Osphena was FDA approved in 2013 for the treatment of painful sex due to vaginal atrophy associated with menopause. Osphena is a SERM (selective estrogen receptor modulator) that acts as an estrogen agonist/antagonist – the same class of drugs as bazedoxifene. Osphena carries with it risky side effects; stimulation of the lining of the uterus that can lead to uterine cancer, increased risk of blood clots, hot flashes and drug interactions.

BUYER BEWARE!

Bio-identical Hormones

The term Bioidentical Hormone Replacement Therapy (BHRT) or “natural hormone therapy” is poorly defined and without a precise medical definition.

Bio-identical hormones are synthesized in the lab from plant sources and as the term implies are pharmaceuticals that closely mimic natural hormones produced in the body since they possess the same molecular structure as endogenous hormones.

There are two classifications of bioidentical hormones; (1) FDA-approved and; (2) compounded in pharmacies based on hormone levels measured in saliva and blood tests (not FDA approved).

The terminology is confusing and the FDA considers “BHRT” to be a marketing term. The lack of distinction between FDA-approved bioidentical hormones (often referred to as synthetics) and compounded bioidentical hormones has resulted in considerable misunderstanding regarding exactly what BHRT is.

The vast majority of advocates of BHRT are referring to the compounded versions where hormones are custom-mixed by a pharmacist – unapproved drugs.

In addition to estrogen and progesterone, these compounded drugs may contain other hormones such as testosterone, DHEA and adrenal hormones extracted from animal glands.  See http://www.health.harvard.edu/newsletters/Harvard_Womens_Health_Watch/2011/September/bioidentical-hormones-help-or-hype

Often promoted as being safer than conventional HRT derived from pregnant mare’s urine, are these claims of a safer alternative justified?

This includes both FDA-approved and compounded hormones. A Harvard Women’s Health Watch article illustrates that there is much evidence to suggest they are not. Other medical articles call attention to the same warnings. See http://www.health.harvard.edu/newsletters/Harvard_Womens_Health_Watch/2011/September/bioidentical-hormones-help-or-hype

In contrast to mainstream thought, compounded BHRT hormones are drugs – just not approved.

As much as it may seem that these hormones are safer than the Premarin® family of drugs, there is no solid evidence to prove this.

Some of these drugs have been approved by the FDA because data collected from trials has proven their effectiveness in relieving menopausal symptoms and reducing the risk of osteoporosis. However there have been no long-term studies like the WHI performed to assess their safety profile.

FDA-approved bioidenticals come with black box warnings analogous to those for conventional HRT. Because compounding pharmacies are not required to detail the risks of their bioidenticals (i.e. they are not approved) they may therefore create the illusion of being safer than commercially marketed drugs.

Overall, FDA-approved and compounded bioidenticals contain the same hormones. The difference between the two is the accuracy of preparation. Where FDA-approved versions are measured precisely under rigid control, compounded bioidenticals lack these specifications. Random testing has shown that the indicated potency of compounded hormones varies substantially.

Blood and saliva tests to measure a woman’s hormones is only a snapshot in time and are not reflective of serum (blood) hormone levels which can fluctuate from hour to hour. In menopausal women hormones levels are particularly unstable without a “normal” concentration. Accordingly dosage may be inappropriate for treating symptoms. Don’t waste your money.

There have been cases of endometrial (uterine) cancer noted among some users of bioidenticals. This underscores the risks associated with using unregulated medications.

Many health insurance companies don’t cover the cost of these compounded hormone therapies.

Although many women believe that these compounded bioidentical therapies are more natural and safer, since they are not FDA approved, they are not tracked or monitored the same way. Some types of bioidenticals have been falsely advertised to prevent breast cancer and heart disease, achieve weight loss and slow the aging process without any studies to back these claims.

There are tens of millions of compounded hormone therapy prescriptions a year filled at community and compounding pharmacies for at least 2 billion dollars – definitely a money-making business.

One might ask how these unregulated products can be sold. In 2001, the US Supreme Court ruled that pharmacies could indeed market compounded products that were unregulated by the FDA. Why? Your guess is as good as mine.

FDA-Approved Hormone Therapy

Contrary to popular belief, the FDA has yet to approve any “true” generic as a substitute for Premarin® and its daughter products (i.e. Prempro®, Premphase®). In other words no prescription drugs used to treat menopausal symptoms, other than the Premarin® family, contain pregnant mare’s urine (this does not include China or other locations outside of the FDA’s jurisdiction).

Currently the vast majority of FDA-approved HRT prescription drugs are synthetic bioidenticals often referred to as “Synthetics” (i.e. hormones identical on a molecular level to endogenous hormones that are synthesized in the lab from natural plant sources) – these are not the versions produced at a compounding pharmacy which are not FDA approved.

What’s important however is that these drugs carry with them the same risks and warnings associated with drugs derived from conjugate estrogen estrogens, whether that be estrogen alone or combined with progestin.

In pre- and postmenopausal women, estrogens can increase the risk of cancer of the ovaries, stroke, dementia, and serious blood clots in the legs.

Estrogen, when used with a progestin, can increase the risk of heart disease (such as heart attacks), stroke, serious blood clots in the lungs/legs, dementia, and cancer of the breast/ovaries.

There are basically four categories of FDA- approved synthetic bioidentical HRT products on the market that do not contain CEEs as shown in the table below, along with their common brand names. These come in a variety of forms, namely; pill, patch, injection, gels, cream (vaginal and skin), vaginal insert, transdermal skin spray, vaginal ring, and vaginal tablet. Some examples that fall into each of these categories are listed. Check with your doctor to determine what product would be more appropriate given your current health and risk factors.

PRODUCT BRAND NAME
Estradiol/Norethindrone
(Estrogen/Progestin Combinations)
Activella, Angeliq, Climara Pro, Combipatch, Femhrt, Jevantique, Prefest
Synthetic Conjugated Estrogen, Estradiol, Esterified Estrogens Alora, Climara, Delestrogen, Dinigel, Divigel, DotCenestin, Elestrin, Enjuvia, Esclim, Estrace, Estraderm, Estrasorb, Estring, Estrogel, Evamist, Femring, Femtrace, , Menest, Menostar, Minivelle, Ogen, Ortho-Est, Vagifem, Vivelle, Vivelle-Dot
Esterified Estrogens/Methyltestosterone
(Estrogen/Androgen Combinations)
Covaryx, Essian, Estratest, Menogen, Syntest D.S., Syntest H.S.
Progestin-Only Medicines Prometrium, Provera

Types of FDA-approved Estrogen Therapy – Pros and Cons

If you elect to take any of the FDA-approved hormone replacement therapies (HRT) the optimum form will depend on your health, your symptoms, personal preference, and what you need to get out of treatment. Below is an overview of the common types available.

Pills

Examples: Estrace, Cenestin, Enjuvia, Femtrace

Pros: Ease of administration, best-studied

Cons: Risks have been well-publicized; increased risk of stroke, blood clot. When in combination with progestin; breast cancer, heart attack. Also cause uncomfortable side effects; painful swollen breasts, vaginal discharge, headache and nausea. Oral estrogens are hard on the liver so people with liver problems should seek alternate forms that do not pass through the liver.

Skin Patches

Examples: Alora, Climara, Estraderrm, Vivelle

Pros: Convenient. Unlike oral forms, estrogen by-passes the liver and goes directly into the bloodstream so they are safer for individuals with liver problems. One study showed that the path doesn’t pose risk of blood clots like oral estrogen however more studies are needed to confirm this. At the moment all estrogen therapies carry the same black-box warning with respect to clot formation.

Cons: Some believe patches are safer than pills however it is too early to know. Therefore, for the time being, assume that they carry the same risks are oral medications. Heat can cause the patch to release the estrogen too quickly so it is important not to expose them to high heat or direct sunlight (e.g. tanning beds, saunas). Similar, yet perhaps milder, side effects as oral dosages.

Topical creams, gels and sprays

Examples: Divigel (gel), Evavist (spray), Estrace and Estrasorb (vaginal and transdermal creams respectively)

Pros: As with skin patches, safer for people with liver problems as they are directly absorbed through the skin into the bloodstream.

Cons: Not well-studied so assume they poses the same risks as other forms (e.g. cancer and stroke). Gels, sprays and creams can rub off before it’s been fully absorbed so it is necessary to allow them to dry prior to getting dressed. Since these forms are absorbed through the skin directly into the bloodstream, it’s important to prevent people from touching any of these as they will inadvertently get a dose of estrogen as well.

Vaginal suppositories, rings, creams and tablets specific to vaginal dryness

Examples: Vagifem (tablet), Estrzce (cream), Estring and Femring (insertable rings)

Pros: Convenient in some cases. These are designed specifically for women who suffer from vaginal dryness, itchiness and burning or pain during intercourse and are more effective than other forms of estrogen for these symptoms. Most are low dose and only affect the immediate are meaning that they can reduce symptoms without exposing the entire body to the effects of estrogen therapy.

Cons: Although these low dose rings and suppositories help with vaginal symptoms, they don’t help with things like hot flashes and mood swings. At higher doses they might help however, may expose you to the same risks as other types.

WORK WITH YOUR DOCTOR

As always, it is important to work with your physician to make an educated decision on what type of HRT would best suit your needs while limiting your risks. Currently, the full risks of HRT are uncertain. For this reason, experts typically recommend the lowest dosage possible for the shortest time possible.

WHAT ABOUT ALL THOSE PREMARIN® CREAM ADS?

As you may have noticed, the Horse Fund has an on-going campaign to help put a stop to Premarin® ads by reporting them to the Horse Fund and by encouraging you to share this personally and publicly, far and wide https://tuesdayshorse.wordpress.com/2017/05/30/report-premarin-ads-on-behalf-of-women-and-horses/ .

Putting a stop to Premarin® ads is one way we can act on behalf of women and horses.

There are more reasons not to use Premarin®, than to use it. And yes, there are many alternatives for vaginal issues related to menopause that do not contain CEEs (conjugated equine estrogens).

Apart from the oral non-hormonal and hormonal alternatives, both the FDA-approved vaginal creams, inserts, rings, suppository and tablets (previously discussed) as well as non-prescription over-the-counter (OTC) products will help to relieve vaginal symptoms of menopause.

Products designed specifically for vaginal dryness and irritation are low dose and only affect the immediate area meaning that they can reduce symptoms without exposing the entire body to the effects of estrogen therapy, unlike oral types, skin patches and sprays for example.

Because these products prevent large amounts of estrogen from passing through the rest of the body, as a rule they are considered safer than other forms of HRT and just as importantly do not contain CEEs like Premarin® cream does.

FDA-approved estrogen products for vaginal dryness

As discussed, there are several FDA-approved vaginal products that will relieve the symptoms associated with dryness, irritation and painful intercourse. All of these are plant-derived estrogens and/or hormones. A list of some of the prescription alternatives to Premarin® cream in their various forms is shown below.

FORM TRADE NAMES / ACTIVE INGREDIENT(S)
Cream Ovestrin (estriol), Estrace (estradiol), Ogen (estropipate), Neo-estrone (estradiol), Estragyn (estrone)
Gel Divigel (estradiol), Elestrin (estradiol), Estrogel (estradiol)
Ring Estring (estradiol), Femring (estradiol acetate)
Tablet Vagifem (insertable tablet containing estradiol)
Suppository Intrarosa (DHEA – dihydroepiandrosterone)

Please consult your doctor for more information on these FDA-approved prescription alternatives to Premarin® vaginal cream.

Non-prescription products for vaginal dryness

There are plentiful other non-prescription products available that women with vaginal dryness may find soothing.

Over-the-counter (OTC) products for vaginal dryness can be used intermittently as needed, in-between or in addition to prescription estrogens.

There is a wide selection of both hormonal and non-hormonal products on the market today to treat vaginal dryness, irritation and painful intercourse.

Over-the-counter estrogen and progesterone creams typically contain bio-identical, or plant- or herbal-based hormones. As with prescription creams, they are intended to relieve common vaginal symptoms of menopause.

The American College of Obstetricians and Gynecologists cautions that there has been insufficient research on the effectiveness and safety of these over-the-counter products, and they are not regulated by the FDA.

There are numerous variants of these OTC commercial offerings available. Please discuss using OTC hormone products with your medical provider prior to use.

As with the OTC hormonal creams there is an extensive selection of natural lubricants available on the market. These are water- or oil-based moisturizers or lubricants that may contain chemicals in some cases. Be sure to read the ingredient labels prior to use.

A few examples of the different kinds of OTC (over the counter) alternatives follow.

PRODUCT WEBSITE
Replens http://www.replens.com/
Julva https://store.cabecahealth.com/products/julva-dr-annas-cream-for-delicate-feminine-parts?variant=29958880899
Vagisil http://vagisil.com/
K-Y Liquibeads https://www.k-y.com/product/k-y-liquibeads-vaginal-moisturizer-6-ea-067981160468
Progesto-Life http://femininehealthreviews.com/smoky-mountain-naturals-progesto-life-full-review-does-it-work/
Estro-Life https://smokymountainnaturals.com/products/paraben-free-estro-life-cream
Sylk https://sylkusa.com/?v=7516fd43adaa
NewEve Silk https://www.neueve.com/silk
Nutrablast http://boricplan.com/nutrablast-boric-life-full-review-does-it-work/
VMagic https://vmagicnow.com/products/vmagic-intimate-skin-cream?variant=16308526343
FabuVag https://www.naturalvaginalsolutions.com/

These are just a handful of examples of probably hundreds out there on the market.

A simple search for vaginal dryness on Amazon.com will give you an idea of just how many and what kinds of OTC products are available.

See https://www.amazon.com/s/ref=nb_sb_noss?url=search-alias%3Daps&field-keywords=vaginal+dryness&rh=i%3Aaps%2Ck%3Avaginal+dryness

Please browse the websites to learn more about these products and consult your doctor to determine whether any would be beneficial in treating your symptoms.

CONSULT YOUR DOCTOR

No matter what, it is important to separate fact from fiction and be astutely aware of the consequences of clinically unproven medications. Apart from the unmistakable benefits of lifestyle changes, before considering any of the alternatives listed please consult your doctor.

What About the Horses Used?

What about the horses used to make pregnant mare’s urine based drugs? It is a life full of abuse tossed or aside or killed when they are of no longer of use.

Why do pharmaceutical giant Pfizer persist with the Premarin line of drugs?  Introduced in the 50s, these drugs are still making millions and millions of dollars.

We are working to stop the heinous abuse of these poor pregnant mares and their vulnerable offspring. To learn more see our Premstoppers campaign on our website.

©The Horse Fund

No need to sweat menopause when you can chill with some rhubarb

Rhubarb Smoothie. One Green Planet.

Updated 10/29 8:14 pm est.

This menopause and rhubarb post by Jane Allin is hitting it big in the Twittersphere.

This is important. The more women who know about the natural healing properties of a plant based diet the fewer women who will be stuffing their bodies full of carcinogenic horse pee drugs such as Premarin, Prempro (some say this horror is still being sold online) and Duavee.

As Allin puts it, “Nothing has been, or ever will be, appealing or beneficial about the PMU industry and the Premarin family of drugs; they are clearly harbingers of death from both sides of the equation”. Learn more at Premstoppers.

Before you run away, check out these super vegan recipes featuring our new best friend the rhubarb plant. It used to grow wild in my Nan’s back garden in England. I love it. Quick reminder. Stalks only please. No leaves.

To save space and time, I will list the ingredients only, and put the link to the full recipe in the recipe’s title. Let’s go.

VEGAN RHUBARB MUFFINS
by Rachel at Bakerita

Ingredients
1½ cup (6 oz.) all purpose flour
⅔ cup coconut sugar
½ teaspoon salt
2 teaspoons baking powder
¼ teaspoon cardamom
⅓ cup coconut oil, melted
⅓ cup unsweetened applesauce
⅓ cup non-dairy milk (I used almond milk)
1 teaspoon vanilla extract
¾ cup chopped rhubarb
¼ cup sliced almonds

How to make it here »


VEGAN GLUTEN FREE RASPBERRY RHUBARB CRISP
by Dana at Minimalist Baker

Ingredients
4.5 cups (total) raspberries and rhubarb mixed (if using frozen, place in colander and briefly rinse under cold water)
2-3 Tbsp cane sugar (or sub sweetener of choice, such as maple syrup or coconut sugar)
1 cup gluten free rolled oats
1/2 cup almond meal, ground from raw almonds
1/2 cup raw pecans, chopped
1/4 cup packed light brown sugar
pinch sea salt
4 Tbsp cold vegan butter, or sub olive oil

How to make it here »


VEGAN RHUBARB MARMALADE
by Jane Orr at Savor the Rhubarb

Ingredients
2 1/2 cups chopped rhubarb
Juice of one lemon
3/4 cup chopped dried figs
1 tsp. cinnamon
3/4 cup water
1/2 cup raw sugar

Bring the rhubarb and figs to a boil on medium heat, and let simmer for 15 minutes. Stirring frequently, add the juice and sugar and simmer until thickened. Let cool, and refrigerate.

How to make it here »


Look at this. Ms. Orr has a recipe for a Rhubarb Gin Cocktail. That really ought to take the sting out of the old change of life thing. No way Pfizer can compete with that.

How about some smoothies?

That suits me. I do not bake very often and always in the mood for a smoothie. And it solves breakfast. These are delectable.

VEGAN STRAWBERRY RHUBARB SMOOTHIE
One Green Planet (Pictured above)
by Jennifer Strohmeyer

1 cup fresh rhubarb, chopped
½ cup orange juice
1 tbsp date syrup or pure maple syrup here
½ tbsp pure vanilla extract
1 cup fresh strawberries, sliced
½ cup frozen strawberries
1 fresh banana
12 oz unsweetened vanilla non-dairy milk of choice

Combine chopped rhubarb, orange juice, date syrup, vanilla and cinnamon in a small saucepan. Bring to a boil, reduce heat to low and simmer uncovered for five minutes . . . see the rest at the link.


Quick side note. Even if you have made it past the hot flash stage I was told by a beautiful 60-something friend the other day that when she “went rhubarb” she found she had softer skin and no more chin whiskers. Those are hormone related issues and the whole thing sounds heaven sent too me.

One more. From across the pond.

RHUBARB, SPINACH AND RASPBERRY SMOOTHIE
The Flexitarian

Ingredients
200g rhubarb [7oz]
1 handful of fresh spinach leaves
1/4 beetroot [55g /2 oz]
150g frozen raspberry [5 oz]
350g silken tofu [12 oz]
250ml oat milk or similar [ 1/2 pint / US 1 cup] – adjust to get your desired consistency
dash vanilla extract to taste
agave syrup to taste
handful of ice cubes


I made it without the tofu and ice cubes. Threw the rest in a blender and gave it a spin. Fab-u-lous.

Let us know if you have a rhubarb recipe you would like to share. Thanks.


FEATURED IMAGE
One Green Planet / Food Monster

RELATED READING

Breast Cancer, Menopause and Yes, Rhubarb by Jane Allin
https://tuesdayshorse.wordpress.com/2016/10/14/breast-cancer-menopause-and-yes-rhubarb/

Grow Your Own Rhubarb
http://www.thompson-morgan.com/how-to-grow-rhubarb
https://bonnieplants.com/growing/growing-rhubarb/
http://www.almanac.com/plant/rhubarb

PREMSTOPPERS
Premstoppers is a Horse Fund campaign to eliminate the making of drugs with pregnant mare’s urine and its decades old legacy of cruelty and death.

Daughters of Premarin — The Generics

Mare with twin foals. Google image.

BY JANE ALLIN

Further to the reference of generics in the “Alternatives To” report, I think a separate word on the availability of generic Premarin® and its daughter drugs is warranted to clear up any confusion for those seeking to avoid products manufactured from the urine of pregnant mares.

Premarin has a long and interesting history when it comes to FDA approval of generics, a history mired in the ruthless and bloodthirsty battle of Big Pharma patent wars.

Many years ago, in 1986, the effectiveness of Premarin’s®, and other short-term acting estrogens, ability to diminish bone loss associated with osteoporosis was granted approval by the FDA. What was once a drug that was prescribed for the relief of menopausal symptoms now became the panacea for a long-term chronic problem. [1] And with this came a huge untapped market.

At this time there were certified generics that were interchangeable with Premarin®. However because of the ramifications of long-term use, the science behind the drugs prevailed.

While Premarin® provided slow-release bioavailability, the generics were immediate release. This disparity in mode of release would turn into a long battle between the generic manufacturers, Wyeth-Ayerst and the FDA. [2]

To make a long story short, the outcome of detailed analysis showed that the bioavailability of generic versions was not equivalent to Premarin® and in 1991 the FDA withdrew approval of all ANDAs (Abbreviated New Drug Applications) proclaiming that none of the synthetics on the market could be considered generic versions of Premarin®. [3]

Because of the lucrative market potential, two generic manufacturers – Duramed and Barr – set out to develop products that solved the bioavailability problem and submitted ANDAs for FDA approval. Both met the requirements of adsorption efficiency however Wyeth had been conducting its own research and contested FDA approval on the grounds that the generic drug lacked one of the estrogens, called delta 8,9 (dehydroestrone sulfate), present in Premarin®. Nevertheless, in 1994, the FDA unanimously ruled that delta 8,9 (dehydroestrone sulfate) was an impurity and not a required ingredient of a generic version.

Duramed applied for FDA approval of Cenestin in September 1995, and Barr followed the next July. [4]

What happened next effectively blocked any competitor from manufacturing a generic Premarin®. Propaganda and political persuasion tactics were used to coerce the FDA and in 1995 Wyeth-Ayerst successfully petitioned the FDA to require the presence of delta 8,9-dehydroestrone in any generic version of Premarin®. [5] Together with Wyeth-Ayerst’s patent on synthetic delta 8,9-dehydroestrone, this shut out the competitors.

Eventually Duramed filed a NDA (New Drug Application) for its synthetically derived estrogen Compound Cenestin which is still available on the market today along with a variety of other synthetic products, none of which contain pregnant mare’s urine.

Premarin® lost its patent in February 2012 and the patent for Prempro® held by Wyeth Pharmaceuticals, does not expire until early 2015.

Despite Premarin’s® patent expiration there seems to be no interest in manufacturing a generic version from pregnant mare’s urine. [6] In any case, it would be challenging for another pharmaceutical company to synthesize a medication that is similar enough to Premarin® to receive the approval of the FDA, similarly so for Prempro® as it contains the same natural conjugated equine estrogens as Premarin®.

The so-called Premarin generics are the lab-synthesized versions manufactured from plant sources not pregnant mare’s urine (see “Alternatives to Drugs Made with pregnant Mare’s urine). [7]

As a reminder, these drugs carry with the same serious risks as the Premarin® family of drugs.

Some will say that generic Premarin® is available online without prescription, particularly from Canada. However be wary of any medications that tout themselves as being a safe generic version of Premarin®. Congressional testimony from the US FDA points out the dangers of inadequately regulated foreign Internet sites which have also become portals for unsafe and illegal drugs. This excerpt specifically targets Canadian generic websites. [8]

A recent example illustrates some of the dangers associated with the purchase of prescription drugs from rogue pharmacy sites. Within the last six months, FDA has examined two web sites having identical web pages headlined “Canadian Generics” which were identified through spam e-mails sent to consumers. FDA has purchased prescription drugs from both of these sites, and has found that these drugs and the manner in which they are sold pose potential threats to the health and safety of consumers.

There is at least one Canadian flag on every page of these sites, as well as the words “Canadian Generics.” The web sites say, “Order Canadian to get the biggest discounts!” Both of the URLs from which the orders were placed suggest the sites are located in, and operated out of, Canada. Despite these representations, however, we determined there is no evidence that the dispensers of the drugs or the drugs themselves are Canadian. The registrants, technical contacts, and billing contacts for both web sites have addresses in China.”

There is currently no therapeutically equivalent version of Premarin® available in the United States. In other words, there is no approved generic for Premarin in the US.

The drug policies and generic approval practices in other countries may vary. What is a generic in one country may not be approved as one in another.

Fraudulent online pharmacies may attempt to sell an illegal generic version of Premarin®. These medications may be counterfeit and potentially unsafe.

If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. [9]

CONSULT YOUR DOCTOR
Always consult your doctor before embarking on any change in medication
_______________

[1] http://pubs.acs.org/subscribe/archive/mdd/v03/i08/html/kling.html
[2] Same as at 1.
[3] Same as at 1.
[4] http://www.sagepub.com/jowett5estudy/cases/77821_c2.pdf
[5] Same as at 4.
[6] http://www.drugs.com/availability/generic-premarin.html
[7] https://tuesdayshorse.wordpress.com/2014/03/25/alternatives-to-drugs-made-with-pregnant-mares-urine/
[8] http://www.fda.gov/newsevents/testimony/ucm113635.htm
[9] Same as at 6.

Premarin Horses: How many does it take to make a billion dollars? Part 3

Newest Member of the Premarin Family ― Duavee

Premarin foals.
Premarin foals.

How will this new drug impact profits and inevitably the PMU mares and their foals?

DUAVEE®, the Premarin® ― bazedoxifene combination therapy for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone hysterectomy was FDA-approved in October 2013 amid speculation regarding its safety profile and Pfizer/Wyeth’s lengthy struggle to gain approval.

Pfizer anticipates that DUAVEE® will be available in the U.S. in the first quarter of 2014.

This is the first approval of DUAVEE® in any country worldwide ― an approval of a combination drug with the component bazedoxifene yet to receive FDA approval on its own ― its approval is valid only in combination with Premarin®, at least in the US ― a conundrum in itself and worthy of further debate.

Some market analysts estimate DUAVEE®’s peak sales to reach $200 million (USD)/annum. [1]

DUAVEE® will be sold as a combination of 0.45 mg CEEs / 20 mg bazedoxifene however no pricing information is available yet as Pfizer has yet to launch it. If it sells for the same average cost per dose as Premarin® ― roughly $3.50 ― the number of mares, in addition to those currently on the pee lines, can be approximated.

Number of doses = Total Sales ($) / Cost per dose ($)
= $200,000,000 / $3.50/dose
= 57,142,857 doses
Total mg required = 57,142,857 doses x 0.45 mg/dose
= 25,714,286 mg
Number of mares = Total mg required / # of mg per mare
= 25,714,286 mg / 9466 mg/mare
= 2,716 mares

However all may not be lost on this new drug.

Despite the fact that Pfizer re-labeled this combination formula as innovative with an improved safety profile over conventional HRT it has a risk history of its own. Originally known as Aprela® Wyeth started work on it in 1999 as part of a program with Ligand anticipating a FDA approval in 2007 however it took 6 more years for the FDA to finally put its rubber stamp on it all the while citing concerns over health risks.

With the still lingering fear of developing cancers from CEE-derived HRT and the fact that there are other best-seller osteoporosis drugs currently on the market ― for example Evista® from Eli Lily which generated $1 billion last year as well and its generic to be introduced within the month ― DUAVEE® may not become the block-buster Wyeth/Pfizer once thought.

Particularly encouraging is that inside information reveals that even Pfizer is vacillating on the roll-out of this drug.

The veil of controversy over safety efficacy and its long and tortuous road to FDA approval seems to have cooled the hype associated with its introduction to the market. In fact speculation has it that Pfizer may never put this drug on the market – a Godsend to the horses and women alike.

Comments made by Pfizer employees on a public forum reveal a decidedly different picture from the one painted by Pfizer-proper. Here are a few interesting and illuminating remarks.

    Look into why this drug has taken so long throughout R&D phases. Wyeth Women’s Health talked about this drug coming to market by 2005.”

    Just wait until the recall. This drug will make your uterus collapse.”

    It’s the biggest joke at Pfizer. Enormous amounts of money being spent for what will be the biggest failed launch since Exubera.”

    Bingo! The cost to promote this DuaDog far exceeds the profitability for the first five years. Any CSO could sell this thing for a better ROI. It’s not rocket science but simple math. Launch is seriously being questioned and could become a no go at any moment.”

    This product is a DOG! I hear that there is debate internally as to whether or not to even launch.”

    DUAVEE: Dropped Uterus And Vaginal Equine Estrogen”.

Shareholders also understand and do not want to bear the brunt of more lawsuits, nor do the innocent women and their families. It is obvious that few have faith in the safety profile of this drug or its marketability ― two risky drugs and limited clinical data makes for a bad recipe.

It is time to stop this madness.

Big Pharma ― rotten to the core ― deception, fraud, kickbacks, price-setting, bribery and illegal sales activities ― anything to keep their profits rolling in. They will stop at nothing to expand their profit base, even if it means harming or killing countless innocents, humans and animals alike.

God bless the mares and their foals and whatever fate awaits them for they are undeniably the persecuted innocents ― without voice or choice they suffer at the hands of greed and merciless degenerates with stilted vision who fail to comprehend the difference between right and wrong ― a capitalist system where underlying principles are lost to a delinquent world that worships money.

    Where in this wide world can men find nobility without pride,
    Friendship without envy, or beauty without vanity?
    Here, where grace is laced with power and strength tempered by gentleness.
    He serves without servility, he has force without enmity.
    There is nothing so powerful, nothing less violent.
    There is nothing so quick, nothing more patient.
    Our pioneers were borne on his back,
    Our history is his industry.
    We are his heirs and he is our inheritance…
    The horse
    .’

    ― ROBERT DUNCAN

END
__________
[1] http://www.fiercebiotech.com/special-reports/duavee-pfizer-stuck-hot-flash-med-took-years-get-market

Links to All Parts of this Report

PART 1: Introduction (A billion dollars ― lots of zeros)
PART 2: Every Figure Tells a Story (Calculations and Result)
PART 3: Newest Member of the Premarin Family ― Duavee (Approved by FDA October 2013, originally submitted under the name Aprela)