Thursday, November 3, 2011

Important Safety Information


What is the most important information you should Stamtrex know about PREMARIN (an estrogen mixture)?
  • Estrogens increase the chance of getting cancer of the uterus.
    Report any unusual vaginal bleeding right away while you are using these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find out the cause.
  • Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.
    Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your chance of getting dementia, based on a study of women age 65 years or older. You and your health care provider should talk regularly about whether you still need treatment with estrogens.
PREMARIN should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. If you are using or are considering using PREMARIN only to treat your symptoms of vaginal dryness, consider topical therapies first. If you are using or are considering using PREMARIN only to prevent osteoporosis due to menopause, talk with your health care professional about whether a different treatment or medicine without estrogens might be better for you.
PREMARIN should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack, have or had blood clots or liver problems, are allergic to any of the ingredients in PREMARIN, or think you may be pregnant. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
In a clinical trial, the most commonly reported (≥5%) side effects that occurred more frequently with PREMARIN than with placebo were vaginitis due to yeast or other causes, vaginal bleeding, painful menstruation, and leg cramps.
PREMARIN (conjugated estrogens tablets, USP) is a prescription treatment used after menopause. PREMARIN is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).
What is PREMARIN?
PREMARIN is a hormone therapy that contains a combination of estrogens. It can help you manage the symptoms of menopause, including hot flashes, night sweats, and vaginal dryness, as well as reduce your chances of developing osteoporosis (thin, weak bones).

PREMARIN is for women without a uterus (hysterectomy) who have moderate to severe menopausal symptoms—hot flashes, night sweats, and vaginal dryness.

When your only menopausal symptom is vaginal dryness, your health care professional may recommend you use a topical vaginal product.
It is best to take PREMARIN at the lowest possible effective dose for the shortest period of time. For this reason, PREMARIN comes in five dosage strengths so that you and your physician can determine which dose is best for you. Studies have shown that PREMARIN was effective in relieving the hot flashes, night sweats, and vaginal dryness related to menopause, and can also help to prevent osteoporosis.

For women who have not had a hysterectomy, and are experiencing moderate to severe menopausal symptoms, PREMARIN can also be used in combination with a progestin tablet. You and your health care professional can decide which approach to managing menopausal symptoms may be right for you.

Is PREMARIN right for me?
If your menopausal symptoms are moderate to severe, PREMARIN may be an appropriate treatment option for you. Every woman is different, but as many as half of the women in menopause will experience some moderate to severe symptoms during the first few years of menopause. You and your health care professional can decide which approach to managing menopausal symptoms may be right for you.

If your only symptoms are vaginal, such as dryness, burning and itching, which can make intercourse uncomfortable or painful, your health care professional may recommend a topical therapy. It is equally important to review your family history with your health care professional prior to beginning therapy with PREMARIN. If there is a family history of heart disease, breast cancer, stroke, blood clots, or osteoporosis, be sure to tell your health care professional.


Important Safety Information

What is the most important information you should know about PREMARIN (an estrogen mixture)?

Estrogens increase the chance of getting cancer of the uterus.

Report any unusual vaginal bleeding right away while you are using these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find out the cause.

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.

Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your chance of getting dementia, based on a study of women age 65 years or older. You and your health care provider should talk regularly about whether you still need treatment with estrogens.

PREMARIN should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. If you are using or are considering using PREMARIN only to treat your symptoms of vaginal dryness, consider topical therapies first. If you are using or are considering using PREMARIN only to prevent osteoporosis due to menopause, talk with your health care professional about whether a different treatment or medicine without estrogens might be better for you.

PREMARIN should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack, have or had blood clots or liver problems, are allergic to any of the ingredients in PREMARIN, or think you may be pregnant. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

In a clinical trial, the most commonly reported (≥5%) side effects that occurred more frequently with PREMARIN than with placebo were vaginitis due to yeast or other causes, vaginal bleeding, painful menstruation, and leg cramps.

PREMARIN (conjugated estrogens tablets, USP) is a prescription treatment used after menopause. PREMARIN is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).

Premarin® -- Production Information Facts


Why the big stink over Premarin? Every year, approximately 75,000 mares are impregnated and tied in small stalls, unable to turn around, take even a few steps, or comfortably lie down. Rubber sacks−which can cause sores−are strapped around the mares' groins so that their urine (known as PMU, or pregnant mares' urine) can be collected to make Premarin. The mares are denied free access to water so that their urine will yield a more concentrated estrogen. The foals Tadacif resulting from these pregnancies are considered unwanted "throwaways," and most are shipped off to slaughter.

"We're letting consumers know that Premarin is a prescription for animal cruelty," says PETA's Lisa Lange. "Women and their physicians can opt not to use a drug cruelly obtained from pregnant mares when great alternatives exist."

Ronald Rust, R.Ph. wrote the following for the Dayton Daily News Oct. 20, 1997. He has given permission to share it with Sans-Uteri members. Ronald G. Rust of Englewood is a registered pharmacist in Ohio and Florida and has been in practice for more than 30-years in both hospital and community pharmacies. If you care nothing about where Premarin comes from or how inhumanely it is gathered, please, at the VERY LEAST go down to paragraph 5 and read for your own health.

POPULAR MEDICATION -- NATURAL FOR A HORSE -- BUT NOT A WOMAN
If it were the only drug available to cure cancer or AIDS or some other catastrophic illness we might well look beyond its means of production. We might look beyond the inhumane treatment of the animals needed to produce it and say that this is necessary FOR NOW, until we can find something better. But we are not dealing with a catastrophic illness and there is something better NOW. We are talking about Premarin, which is used as estrogen replacement therapy for women who are post menopausal either naturally or caused by surgical removal of their ovaries.

The manufacturer of Premarin, Wyeth Pharmaceuticals, maintains that this drug is "exclusively from natural sources". Yes, they are correct. Horse urine is natural, but so is manure. Why do we want something just because it is "natural"? It is a natural product to use for anyone whose natural diet includes hay. If we are looking for something natural for a human female there are many other products on the market that are far superior and not made from pregnant mares urine.

More about the other products later but let's talk about the means of obtaining this natural horse urine. Let's take a "trip" to North Dakota and the Canadian provinces of Alberta, Manitoba and Saskatchewan where we will find about 450 PMU (Pregnant Mare Urine) farms. There is little or no government regulation of theses farms, just the loosely enforced "Recommended Code of Practice" of Wyeth Pharmaceuticals, the manufacturer of Premarin. This seems analogous to having Dillinger guard the bank.

Each year, 70,000 to 80,000 mares are impregnated and placed in stalls so tiny that they are barely able to turn around or lie down comfortably. They are placed in a urine collection harness and rarely taken off the "production line" for exercise or any other reason. Straps firmly hold a rubber cup on the mare's urethra to catch every drop of the precious urine. The continuous standing on concrete causes swollen legs and crippling. Urinary tract infections are not uncommon and many of these horses die as a result of the stress, only to be replaced by another "disposable" horse. Since the FARMERS ARE PAID ACCORDING TO THE CONCENTRATION OF THE ESTROGEN IN THE URINE, many mares are given less water than they would normally get. This increases not only the estrogen concentration of the urine but also the bottom line.

Premarin is so widely used because it was the first product of its kind for estrogen replacement therapy. It continues to be used, not because it is superior to the other available therapy but because it is what doctors are told is the best. They are told by a company with a huge advertising budget who has a lot to lose if doctors begin prescribing other estrogens.

Although commonly thought of as a single substance, estrogen actually consists of several different but related hormones. Human estrogen consists of ESTRIOL (60-80%), ESTRONE (10-20%), and ESTRADIOL (10-20%). Horse estrogen by contrast contains primarily only one human estrogen, ESTRONE (75-80%), plus several other estrogens found EXCLUSIVELY in horses (emphasis added). As you can see, Premarin is indeed natural, for a female horse, but about as natural for a woman as a hearty meal of oats and alfalfa.

Does all this mean that a woman's only choices are horse estrogen or hot flashes? The answer is a resounding NO! Estrogen from natural plant sources compounded to a woman's exact needs as determined by her doctor, are available with a prescription from a compounding pharmacist. Although less desirable than the compounded product, other estrogens such as estradiol are obtainable at any pharmacy with a doctor's prescription. They are naturally occurring and as such not patentable. For this reason they will not be promoted to your doctor by a drug manufacturer with a big advertising budget.

Women no longer have to be a party to the inhumane treatment of horses or take a product that is natural only to horses.