FDA rejects possible Premarin replacement drugs

By Jane Allin, Typewriter Keys

Belgian Quarter Horse crosses are the most used for the collection of pregnant mare's urine for the production of drugs like Premarin and Prempro.
Belgian / Quarter Horse crosses are the most used horses for the collection of estrogen rich pregnant mare’s urine used in the production of HRT drugs Premarin and Prempro. Untold hundreds of thousands of mares have suffered and their foals killed.

With concerns about risks associated with conventional hormone replacement therapy (HRT) manufactured from the urine of pregnant mares (i.e. Premarin®, Prempro®) Depomed Inc., a specialty pharmaceutical company headquartered in Newark, California, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on July 31, 2012 for Serada™ – an extended time release formulation designed to provide women with prolonged relief of menopausal “hot flashes” with potential for reduced side effects.

Approximately one month later on August 29, 2012, Noven Pharmaceuticals announced that it had submitted a NDA for low-dose mesylate salt of paroxetine (LDMP) to the FDA also seeking approval for the treatment of vasomotor symptoms associated with menopause.[1] LDMP is an investigational oral non-hormonal therapy specifically developed for the treatment of vasomotor symptoms due to menopause.

Hormone replacement therapy manufactured from pregnant mare’s urine is currently the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes

The FDA formally accepted the application for Serada™ on October 15, 2012 and established a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013.[2] Similarly, the application for LDMP was also accepted with an assigned PDUFA action date of June 28, 2013.[3] These dates represent the goal date for the completion of the FDA NDA review.

Hormone replacement therapy manufactured from pregnant mare’s urine is currently the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes.[4] In the United States alone there is an estimated 32 million women who experience menopausal hot flashes, of whom 13 million seek medical treatment.[5]

Moreover, vasomotor symptoms – hot flashes and night sweats – are the most common medical complaint of perimenopausal and postmenopausal women affecting upwards of 80% of women experiencing menopause.[6] In fact, there is evidence that sleep disturbances due to moderate to severe hot flashes is the leading driver of women seeking prescription HRT products.[7]

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15 thoughts on “FDA rejects possible Premarin replacement drugs”

  1. Apparently I’m one of the very lucky ones…I actually had to be convinced by my doctor that I had in fact proceeded through the entire menopause syndrome – without knowing it! :)

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  2. Years ago my dr at the time prescribed Premarin. Took it for several months before I found out where it comes from! That was the end of that.

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  3. None of us will ever know how much money Pfizer has shelled out to the FDA over the years. I never took any of the drugs my doctor tried to push on me for hot flashes. I lived in AZ so you really couldn’t tell a hot flash from the 110 degree weather. I never had any problem with it. Not taking any of the drugs probably saved my life.

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  4. Vivian – I love it when you and Jane Allin get your research on; it’s SO important that women understand menopause isn’t a disease nor is it terminal and there are so many alternatives to (you should pardon the crudity) mare piss and slaughtered foals.
    I have to wonder about the hue and cry up from the male population if it were known that Viagra was derived from conjugated bull sperm…(it isn’t, but it amuses me to ponder it so.)
    Is it wicked of me that I actively pursue those vitamin and mineral supplements or herbal remedies that specifically state “This (product) has not been evaluated by the Food and Drug Administration”? It astonishes me this agency is still in business, that it’s recommendation are still held sacred and that it’s opinions carry global weight.
    That’s why these articles are so important, even outside the horse community. Women need to know our health is not now, nor has it ever been, the top priority – our money is.

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    1. Thank you Lisa. Jane has done a stellar job once again. The horses are blessed to have skills working in their defense. Insofar as any of those government alphabets, I feel the same way when I see the USDA sticker on food.

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  5. Many women who have to go on to hormones during menopause, are now using bio-identical hormones which are derived from plants and have less risk.

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  6. Premarin killed my mother,she died 4 years ago from breast cancer. There are safer options out there,I took Prozac for hot flashes and it was like a miracle drug. Went from one hot flash right after another all day every day ….then none at all when I took the Prozac. I took it for 4 years and quit,now I might have one hot flash per day. It works ladies!!

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  7. I will be writing the FDA!!! I take Estradiol which is plant based and cost $4.00 a perscription and safe….Premarin is $80.00…… They are thieves!!!!

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    1. I used Estradiol as well and it was great! I told my doctor I refuse to take Premarin and she said Estradiol is just as effective. However, she did take me off it after a year and a half (the recommended length of time before risk of breast cancer). She takes her patients off ALL HRT’s after a year and a half, including Premarin due to the same risks. She suggest supplements to replace HRT’s.

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  8. Women like Premarin also because their wrinkles are not as noticeable. But taking the drug can lead to cancer and doctors have taken their patients off of it. Breast cancer is nothing to disregard, while this is criminal for our mares and their foals.

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  9. God forbid that we should stop the suffering of the mares and use something that would not cause harm. There are herbal alternatives out there that work just as good. This is all about the drug companies wanted a hold on your money.

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