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 /td> 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

New study damns results of WHI report on Premarin family of drugs

Menopause Lane Street Sign. Author unknown.

by JANE ALLIN

New Study

Another new study published September 12, 2017 in the Journal of the American Medical Society (JAMA) has made headlines claiming that HRT is not the villain it was once thought to be.

Per the investigators, a statistical review of the results of the damning 2002 WHI study showed that the women taking the hormones did not die earlier or have higher incidence of chronic illness than those taking a placebo.

In fact, to the contrary, this new study asserts that these women experienced a profusion of benefits as a result of taking the HRT – improving the quality of life, preventing osteoporosis, heart disease and Alzheimer’s, and of course a satisfying sex life among other advantages.

An author who penned an article in the Huffington Post by Erika Schwartz MD, self-described as a physician who is a hormones and prevention expert, even goes so far as to tout them as miracle drugs. Laughable at best.

“Hormones are great for you. You are better off with any kind of HRT (bioidentical estradiol, testosterone, conjugated equine estrogen, etc.) than nothing. The WHI study was a most horrific insult to women’s health in recent history. It hurt and still does millions of women. Women are suffering because money was more important than pure science and honest medical discourse.” [1]

Pfizer World Headquarters. Reuters.
Pfizer World Headquarters. Reuters.

How was money more important than science and honest medical discourse? If anything, the WHI resulted in huge losses in profits for Big Pharma, notably Wyeth, now a wholly owned subsidiary of pharmaceutical giant Pfizer.

Moreover, Wyeth was guilty of covering up the truth about HRT and its link to increased incidences of cancer, heart disease and other life-threatening ailments in pursuit of higher profits at the expense of women. A classic example was the use of ghostwriters hired by Wyeth for this very reason.

“The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.” [2]

In any case, the study: “Menopausal Hormone Therapy and Long- term All-cause and Cause Specific Mortality; The Women’s Health Initiative Randomized Trials” in its entirety is available here  and a brief overview and summary of results can be found here.

The study was an observational follow-up of more than 27,000 postmenopausal women aged 50 to 79 years who were enrolled in the 2 WHI randomized clinical trials between 1993 and 1998 and followed up through December 31, 2014 – a cumulative total of 18 years.

These two trials — the original WHI study, and a second WHI study published two years later — found that taking estrogen plus progestin (Prempro) HRT increased a woman’s risk of heart disease and breast cancer while taking estrogen alone (Premarin) increased the risk of stroke, dementia, and other health dangers including endometrial cancer.

Trio of Rescued Premarin Foals. Photo: Vivian Grant Farrell
Trio of Rescued Premarin Foals. Photo: Vivian Grant Farrell.

The new study published in JAMA on September 12, 2017 strongly supports the claim that hormone therapy with CEEs (conjugated equine estrogens) in combination with progesterone (e.g. PremPro) and CEEs alone (Premarin) are not associated with “all-cause” mortality. In other words, they are trying to convince women that HRT therapy is not harmful, will not kill you nor shorten your life – those women who took the drugs to alleviate the symptoms of menopause were no more likely to be dead after 18 years than those who didn’t.

“Among postmenopausal women, hormone therapy with CEE plus Progestin (PremPro) for a median of 5.6 years or with CEE alone Premarin for a median of 7.2 years was not associated with risk of all-cause, cardiovascular, or cancer mortality during a cumulative follow-up of 18 years.”  [3]

Specifically, HRT taken for 5 to 7 years was not associated with risk of long-term “all-cause” mortality.

So they say.

Yet in the same breath, they continue to advise restrictions on its use based on the age of onset of menopause, the lowest dose possible, for the shortest duration possible, not to be taken with existing risk of cancer and heart disease, blah, blah, blah . . .

“Although these findings lend support to practice guidelines endorsing use of hormone therapy for recently menopausal women with moderate-to-severe symptoms, in the absence of contraindications, the attenuation of age differences with longer follow-up and potential health risks of treatment would not support use of hormone therapy for reducing chronic disease or mortality. Moreover, it is unclear whether benefits would outweigh risks with longer duration of treatment.” [4]

As with other prescription medications and the plethora of warnings, contraindications and precautions, how safe are these drugs, particularly given past studies other than the WHI trials have also shown them to be harbingers of heart disease, cancers and other maladies?

As a matter of fact, according to their analysis, the researchers found that there was indeed a “statistically significant” increase in breast cancer incidence in women who took the combination CEE and Progestin HRT (Prempro) – the same findings as the WHI and other independent studies of which there are many.

“Total cancer mortality did not differ significantly between intervention and placebo groups in either trial despite the increased incidence of breast cancer with CEE plus MPA34 and concerns about an increased risk of hormone-sensitive cancers with both regimens”. [5]

Yet this “critical finding” is obscured in the blanket statements in the many articles circulating the Internet that extol the benefits of HRT as a direct result of this study.

Sadly, often these warnings are not passed on to the unsuspecting patient and are glossed over, even by their physicians. One need only listen to the sweeping comments made by Erika Schwartz, MD, the hormone expert who authored the paper referred to above; “Principal Investigators of 2002 WHI Study Reverse Findings — HRT vindicated in new JAMA article”.

Not only does she recommend all forms of HRT to her patients, as well as making the ridiculous statement that women are suffering because money was more important than science when in fact, money had nothing to do with it — sales of Premarin and its derivatives plunged after the results were released — she has this little rant to add:

“Now oddly media coverage hasn’t really done this report justice. It has been casually covered as a ray of hope but not as the wake-up call it MUST be. While in 2002 the media frenzy killed HRT, the JAMA report was interpreted as light reassurance for HRT. That’s just not right. There is no doubt here. HORMONES DO NOT HARM WOMEN, the medical establishment dogma does.” [6]

Seriously?

The researchers themselves have underscored the limitations of the study, caution the interpretation of the results and warn that cause-specific mortality analyses should be considered exploratory. If that isn’t from the horse’s mouth what is?

So, what to make of this? What prompted these original researchers to revisit this 25 years after the fact? To right a perceived wrong in the hope that the whole debacle of the HRT debate goes away once and for all? To help lessen the stigma so that there will be a resurgence of sales of the Premarin family of drugs?

Your guess is as good as mine, but I am betting it has everything to do with Pfizer’s bottom line.

There is no reason to think that a new study is right and all the previous studies are wrong. But if they are profit driven this is exactly what the drug companies want people to believe.

Class Action Lawsuits

And what about all those class-action lawsuits? Are they suddenly moot? These were massive suits involving thousands and thousands of women, some surviving and others dying. If these drugs don’t cause cancer why on earth did Wyeth/Pfizer lose these lawsuits, many of which were unlawful death suits? Do people really think that companies such as Wyeth and Pfizer have no leverage? Money talks.

The science is there but it seems that there is always some new study funded by these mammoth pharmaceutical companies to cast doubt on the findings if they are not in support of pushing their drugs that make lucrative profits — money before patient safety. In fact, for this study, Pfizer was paid for consultancy and review activities.

Conflict of interest? You be the judge.

As Peter Gotzsche M.D., Director of The Nordic Cochrane Centre and author of “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Health Care” points out:

“Much of what the drug industry does fulfills the criteria for organized crime in US law,” Dr. Gotzsche said in a recent interview. “And they behave in many ways like the mafia does, they corrupt everyone they can corrupt, they have bought every type of person, even including ministers of health in some countries . . . The drug industry buys the professors first, then chiefs of departments, then other chief physicians and so on, they don’t buy junior doctors.” [7]

Menopause Lane Street Sign. Author unknown.
Unattributed Google search result.

Lies, Damn Lies and Statistics

The approach to this study is not new and similar studies have been made in the past — for example, one in 2013:

Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women’s Health Initiative Randomized”. (http://jamanetwork).

One of the key points is that in these studies the results of the WHI are broken down by age groups, rather than individuals treated as a single cohort. The other principal factor is that the statistical analysis used in both the current and 2013 study was hypothesis testing (statistical significance) using “P values”. And in each case, the conclusions were the same — HRT is safe (with some restrictions).

While this age-stratified analysis is a good approach, what of the actual statistical method used to arrive at the conclusions?

Without going into detail about hypothesis testing and the use of “P values” to predict the significance of an event, this statistical method and its applicability to medical research has been shown repeatedly that conclusions based on calculating “P values” are frequently false. Just as statistical significance does not always mean a result is real, lack of statistical significance (which they are using in this study) does not mean that there is no effect.

In fact, observant experts have been pointing out serious flaws in standard statistical testing for decades. In recent years, the depth of the problem has become more apparent and better documented, yet the medical community continues to employ these methods simply because these methods have been embedded in the scientific process. In effect, it is not just medical research, but all research fields, that often draw erroneous conclusions.

Even the researchers warn of caution when interpreting these results:

“Finally, the nominal P values presented here should be interpreted cautiously, as multiple outcomes and subgroups were examined. Thus, cause-specific mortality analyses should be considered exploratory.” [8]

And yet, this new study is being promoted as leading-edge “feel-good” news for menopausal women across the globe via social media without recognition of the caveats associated with the results. Reckless endangerment at its best.

Yes, ladies, you can breathe a sigh of relief. Or not.

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.” [9]

In truth, the best solution to determine the safety of HRT on the health of menopausal women would be to repeat the experiment without the flaws that existed in the original WHI studies. Unfortunately, often studies are too complicated, lengthy or expensive to repeat.

Or, as in this case perhaps, the drug company does not want to pursue a wholly comprehensive study as it will further affect sales if found to negatively impact the health of patients, just as it did originally – why take the time and money if only to find that HRT does in fact cause heart disease, cancer and the like.

That is both a financial risk and a precarious risk where damning results could leave a stain on the brand name and negatively affect profits if the results are published. However, drug companies publish only a fraction of the studies they fund — the ones that promote their drugs. Unwanted results are not published.

Sadly, doctors must rely on academic peer-reviewed medical journals to learn about prescription drugs and pass these findings onto their patients in the way of prescription medications. What choice do they have?

“Pharmaceutical companies know this and have worked hard to sway the leadership. Now the question comes up if we can trust the data that the leadership relies on. One wonders how deep the deception goes. In fact, the heavy influence of pharmaceutical dollars inspired the former editor-in-chief of the New England Journal of Medicine, Dr. Marcia Angell, to conclude, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.”  [10]

In the News

It is always tempting for journalists and scientists alike to report a finding that is contrary to popular belief. This is no exception.

For years after the damning result of the WHI study, and to this day forward, HRT has been a controversial subject. When a study emerges that defies previous findings, often the magnitude of the effect is overstated and the less likely the research findings are to be true.

Then there is the enticing phrase “Contrary to previous scientific belief . . .”.

“Ordinarily, “contrary to previous belief” should be a warning flag that the result being reported is likely to be wrong. Instead it is usually a green light to go with the story. So the general criteria of newsworthiness—a first report, in a hot field, producing findings contrary to previous belief—seem designed specifically to select the scientific papers most likely to be bogus.” [11]

Add to this, the HRT media campaigns by Pfizer and others that underplay the dangers of cancer and heart disease. These types of studies that shine a positive light on the use of HRT to control symptoms of menopause clearly add more arsenal to their strategy. Billions are spent on direct-to-consumer ads promoting drugs that Big Pharma say are intended to raise awareness of treatment options.
The truth is, direct-to-consumer advertising is used to drive choice rather than inform it – the ‘driving’ typically in the direction of expensive brand-name drugs. [12]

The only two countries in the world that allow direct-to-consumer advertising are the U.S. and New Zealand.

Survey’s carried out in both countries have shown that when a patient asks for a specific drug their family physician is likely to prescribe that drug over others such as generics or alternatives, for example.

But it is more insidious than this since the ugly truth is that doctors are being enticed by pharmaceutical companies to prescribe their drugs.

In a gullible nation that has been brainwashed by Big Pharma, and their physicians who receive 95% of their information from this very source, there is little difficulty persuading the masses that drugs are the answer to any “condition” although many of these so-called illnesses are treatable by lifestyle changes or, in effect, are not diseases at all. [13]

Such is the case for the ubiquitous Premarin family of drugs.

Prescription drugs are killing us. Arnold Seymour Relman. Image Source: True Activist.
“The medical profession is being bought by the pharmaceutical industry, not only in terms of practice of medicine but also in terms of teaching and research.” Arnold Seymour Relman. Image Source: True Activist.

So, I leave you with this.

“The medical profession is being bought by the pharmaceutical industry, not only in terms of the practice of medicine, but also in terms of teaching and research. The academic institutions of this country are allowing themselves to be the paid agents of the pharmaceutical industry. I think it’s disgraceful.” – Arnold Seymour Relman (1923-2014), Harvard Professor of Medicine and former Editor-in-Chief of the New England Medical Journal [14]

[1] [6] http://www.huffingtonpost.com/entry/principal-investigators-of-2002-whi-study-reverse-findings_us_59bf0771e4b06b71800c3aed

[2] http://www.nytimes.com/2009/08/05/health/research/05ghost.html?pagewanted=all

[3] [4] [5] [8] https://preview.thenewsmarket.com/Previews/JOUR/DocumentAssets/483786.pdf

[7] [10] https://www.thedailybeast.com/big-pharma-is-americas-new-mafia

[9] https://www.acsh.org/news/2015/05/19/science-publication-is-hopelessly-compromised-say-journal-editors

[11] http://nautil.us/issue/4/the-unlikely/sciences-significant-stats-problem

[12] http://www.who.int/bulletin/volumes/87/8/09-040809/en/

[13] https://tuesdayshorse.wordpress.com/2014/07/23/pushing-premarin-big-pharma-big-bucks-part-1/

[14] http://www.collective-evolution.com/2016/05/14/pfizer-vp-comes-clean-tells-the-truth-about-pharmaceutical-companies-video/

© The Horse Fund

WHI — Women’s Health Initiative

The Women’s Health Initiative (WHI) was initiated by the U.S. National Institutes of Health (NIH) in 1991. The Women’s Health Initiative, which consisted of three clinical trials (CT) and an observational study (OS), was conducted to address major health issues causing morbidity and mortality in postmenopausal women.

Related Reading

Further reading on the use of “P values” and other sources of statistical error:

“Why Most Published Research Findings are False” http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124

“A Dirty Dozen: Twelve P-Value Misinterpretations” http://exp-platform.com/Documents/2017-08%20KDDMetricInterpretationPitfalls.pdf

“Science’s Significant Stats Problem” http://nautil.us/issue/4/the-unlikely/sciences-significant-stats-problem

Don't sweat the latest report damning WHI report on Premarin. Take an alternative.
Don’t sweat the latest report damning WHI report on Premarin. Take an alternative.

Women — Don’t Sweat It

Don’t sweat it concerning these drugs and the confusion surrounding them. Work with a health care professional to find the right alternative for you. Here are some good alternative avenues for you to explore.

More at Tuesday’s Horse

• Horse pee reduces breast cancer. Say what? by Jane Allin
https://tuesdayshorse.wordpress.com/2013/06/13/horse-pee-reduces-breast-cancer-risk-say-what/

Premarin Horses

March for Premarin Horses featured image.
Pfizer’s Premarin family of HRT drugs is made from the urine of pregnant mares.

The Premarin family of drugs is made from the estrogen rich urine of pregnant mares. Hence the name Pregnant Mare’s Urine.

The conjugated equine estrogens produced from the urine of pregnant mares to make these drugs have been declared known carcinogens by the World Health Organization.

See all posts on Premarin Horses »

Learn how more about how these horses are used and what happens to cast off mares and byproduct foals at Premstoppers at http://horsefund.org/premstoppers-home.php.

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Please share far and wide, on behalf of women and horses.

 

 

 

Turn your back on Premarin type drugs and seek alternatives for symptoms of menopause

October is Breast Cancer Awareness Month and as it draws to a close we urge women to please turn your backs on Premarin type drugs — tablets and cream — and seek another treatment for menopausal symptoms.

There are alternatives.

Work with your doctor to find something to help you other than drugs made from pregnant mare’s urine — for your sake as well as the innocent mares and their byproduct foals.

Crazily I have had doctors argue with me that the Premarin family of drugs are not made with conjugated equine estrogens derived from the urine of pregnant mare. The absence of the word “equine” on the packaging is proof enough for them.

Of course “equine” was removed some years ago. Yes, we heard about it and we know how and why. I assure them that the key component of the drugs taken from the estrogen rich urine of pregnant mares remains the same. End of discussion.

I share this with you in case you encounter this argument yourself whether it be with a physician trying to prescribe it to you or when trying to warn someone who is taking it.

THE ALTERNATIVES

Jane Allin put together a list of alternatives to drugs such as Premarin, Prempro, Duavee and Duavive (See also pdf version at the end of this post).

Duavee by the way is the name given to Aprela when it was approved by the FDA during the last federal government shutdown and is being peddled in Europe under the name Duavive.

We asked Jane to review her report on alternatives and give us any updates. This is what led to Jane’s recent post on Tuesday’s Horse regarding the helpful properties of rhubarb. See Breast cancer, menopause and yes, rhubarb.

This in turn launched me on a vegan rhubarb recipe hunt which you can find here. See No need to sweat menopause when you can chill with some rhubarb.

Other than that there are no notable changes.

Please keep reporting those Premarin television and magazine ads!

Thank you.

PDF
Alternatives to Drugs Made with Conjugated Equine Estrogens by Jane Allin (pdf, 7 pp)

FURTHER READING
Premstoppers Home »
Reports Regarding Premarin Horses »
Images of PMU Horses; Images from PMU Farm in China »

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.