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Review And Side Effects Of Duavee: The New FDA Approved Osteoporosis Drug

duavee-approved

A few days ago, on October 3rd, pharmaceutical giant Pfizer announced the FDA’s approval of its brand new osteoporosis drug Duavee. It’s designed to decrease hot flashes in menopausal women, and treat osteoporosis in post-menopausal women who have not had a hysterectomy. It will be available for prescription in the US in 2014.

Is Duavee any different from the already existing dangerous (and pathetically failing) osteoporosis drugs?

Let’s explore…

How Duavee Works

As soon as I saw what “conditions” Duavee is supposed to treat, it raised a red flag. Any drug that is touted as treating menopausal symptoms and osteoporosis must have something to do with hormone supplementation. And as Savers know, hormone replacement therapy (HRT) is never recommended in the Save Our Bones Program.

Duavee contains conjugated estrogens and bazedoxifene. Conjugated estrogens are the main ingredient in the popular hormone replacement drug Premarin. Bazedoxifene is a selective estrogen receptor modulator, or SERM, which means it acts on estrogen receptors in certain tissues by mimicking the hormone.

If you are a regular reader of this site, this probably sounds familiar to you. It should – the osteoporosis drug Evista works very similarly.

Hormone replacement therapy has been around for 60 years. But over the last 2 decades, concerns have arisen over HRT’s role in breast cancer and other undesirable and often serious side effects.

Not surprisingly the prestigious journal Lancet published a collaborative analysis of more than 50 studies. The analysis concludes that “The risk of having breast cancer diagnosed is increased in women using HRT and increases with increasing duration of use.”1

In addition, other dangerous and even deadly side effects began to surface in women taking hormone drugs: deep vein thrombosis, stroke, and blood clots to name a few.

Understandably, many patients and consumers became concerned about the safety HRT. But it seems as if those concerns have not resonated with the pharmaceutical companies… for sure not with Pfizer.

Or is it that…

Big Pharma is Running Out of Ideas to Treat Osteoporosis?

It’s tempting to think that since Duavee is a newly “approved” drug, it could be “safer” than its predecessors. But of course it’s not. It’s really all about a marketing ploy. I’ll explain.

You see, Big Pharma likes to promote these sorts of drugs as “the latest and greatest” for a variety of reasons. For one thing, uninformed patients mistakenly believe that the newer drug will not have the same dangerous side effects as the previous one(s). In addition, marketing old drugs as new ones gives Big Pharma the opportunity to patent the “new” drug and continue to rake in huge profits.

Public awareness of HRT’s dangers means that Pfizer won’t advertise Duavee as just another form of HRT. Instead, it has made a few tweaks to its general formula – basically adding bazedoxifene to the ingredients in Premarin – so they can claim it’s “different” and “better”.

Simply put, Pfizer combined two already existing ingredients with known side effects and declared the combination something innovative and novel.

That means they can patent it, call it by another name, and no one will be the wiser. …no one, that is, except you. Because fortunately, Savers are well ahead of the game.

Duavee’s Side Effects Roulette

Just what are some of these boxed warnings? Here they are, directly from Pfizer’s website:

  • Increased risk of endometrial cancer
  • Increased risk of stroke and deep vein thrombosis
  • Increased risk of dementia in women over age 65

These are Duavee’s “Warnings”

  • Risk of cardiovascular disorders may increase
  • Endometrial, breast, and ovarian cancer are more likely
  • Gallbladder disease can occur
  • Loss of vision is possible
  • Women taking thyroid hormone should be carefully monitored.

Clearly, Duavee’s side effects and “warnings” are very serious and potentially life-changing.

Duavee’s Possible Adverse Reactions

  • Nausea
  • Diarrhea
  • Dyspepsia
  • Upper abdominal pain
  • Throat pain
  • Dizziness
  • Neck pain

Sadly, as patients experience these side effects and reactions, their discomfort will likely be addressed with more drugs (painkillers, anti-inflammatories, etc.) or even surgery.

It’s a Natural Process: Hormones Dwindle with Age

Menopause is a natural process. Like osteoporosis, it is not a disease that needs to be treated or prevented. As I said earlier, the best thing you can do is support your body through the process with a healthy diet and lifestyle, as described in the Save Our Bones Program.

You’ll Never See a Black Box Warning on the Save Our Bones Program!

That’s because the Save Our Bones Program is a 100% safe, scientifically-backed osteoporosis treatment that is simple and easy to understand. The comprehensive lifestyle and nutritional guidelines show you how the food you eat influences bone-degrading systemic acidity, and how to easily correct the pH imbalance, among other things.

A Recipe Sampler included in the Program and extensive food lists make it easy to prepare and enjoy delicious, pH-balanced meals and snacks that promote a more alkaline body environment while providing bone-building nutrients. In addition, the Program covers the importance of exercise in building bone density, and much more.

The Program is completely risk-free – with our one year, double-your money-back guarantee, you have nothing to lose and much to gain.

If you don’t have the Program yet, think about this: are you willing to play the “side effects roulette” game? Are you ready to gamble with your health for the sake of building bone density? I’m here to tell you that fortunately, you don’t have to.

Please click here to learn more about the Program.

Till next time,

References

1 “Breast cancer and hormone replacement therapy: collaborative reanalysis of date from 51 epidemiological studies of 52,705 women with breast cancer and 108,411 women without breast cancer. Collaborative Group on Hormonal Factors in Breast Cancer.” Lancet. October 11, 1997. 350(9084): 1047-59. Web. http://www.ncbi.nlm.nih.gov/pubmed/10213546

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30 comments. Leave Yours Now →

  1. Dorris Dembosky May 13, 2014, 6:31 pm

    I have been watching a lot lately, on Dr.Oz , Opra and others about Garcinia. I think now I will make the leap of faith – I need to lose about 25-30 kilos.., hope that works out for me.!

    http://buyer-reviews.org/garcinia-slim/

  2. DrChuckyHormoneSpecialistResearcher October 26, 2013, 8:55 pm

    Vivian, I am very familiar with duavee and the whole general are. I’m not sure where your hormone knowledge comes from or what would give you so much confidence to suggest to women things that are so misleading, superficial and frankly, dangerous to their health!

    It simply astounds me that with better and better medicines, increasingly sophisticated clinical trials that look at thousands of patients over many years in double-blind placebo-controlled studies, we end up back somewhere in the 18th century where fear and superstition ruled the day. Back then of course they did have an excuse since there wasn’t much good in the way of science so might as well use the imagination.

    For example, when you talk about bis-phosphonates and osteonecrosis of the jaw or long bone fractures, why don’t you put the absolute risk in balance with the proven reduction in hip fractures, spine fractures and other fractures? Are you aware of how devestating hip fractures and bis-phosphonates reduce them by 1/3 to 1/2 which amounts to preventing many thousands of hip fractures every year in the US alone? Every drug has something wrong with it but it has benefits too! The object is to objectively weight them and make a rational decision. Is putting honey on your face or ice or taking calcium really an effective alternative to anything? If so, where are the controlled studies?

    With regard to all the hormone nonsense, I really hope at least some of the women who follow this board will take the time to understand the risks of HRT, the types of HRT and their age when starting. If they did, they would know that the premarin estrogen by itself, in the WHI study did not increase breast cancer, it actually reduced it! It prevented bone fractures! In women under 60 who started on estrogen, they had less cardiovascular incidents and even saw reduction of calcium plaques in their arteries. And for the women out there who think because something comes from horses it must be evil or bad in humans, I assume you do not eat any animal derived products or drink milk or eat eggs? The ironic thing is that the premarin estrogen is the only estrogen that actually reduced breast cancer in a controlled clinical trial, research has shown that it does not stimulate mammary tissue the way regular (or bioidentical estrogens do). Premarin also increases HDL quite well while lowering LDL. It relaxes epithelial tissue in arteries, making them less likely to stiffen up and cause heart attacks. But hey, why actually study anything when we have Dr Vivian here to guide us along.

    With regard to Duavee, it has the premarin component which is known to prevent breast cancer, heart disease in women under 60 and bone fractures. The brilliance and breakthrough of Duavee is that they removed the progestin in combination products and replaced it with a different type of estrogen. Knowledgeable folks now understand that progestins in combination with estrogens lead to most of the issues. The only reason it is used at all is because estrogen by itself will stimulate the uterus and continuous stimulation is not good, the progestin protects the uterus but in return, increases breast cancer risk instead of decreasing it, blunts the cardiovascular and lipid benefits, causes intermittent bleeding (spotting), breast tenderness, bad moods, etc. They replaced the progestin with a seapate estrogen, bazedoxifene, that is a SERM that has been clinically proven by itself to not cause breast cancer while still protecting against fractures. However, bazedoxifene does not prevent hot flushes so its not much good besides preventing bone fractures and breast cancer. However, bazedoxifene is a special SERM in that it very potently blocks the effect of estrogen on the uterus. Combining bazedoxifene with premarin gives the benefits of premarins without the problems that the progestin introduces. The net result is a breast friendly, no bleed treatment for hot flushes and osteoporosis. It has some positive vaginal effects as well though it is not indicated for that – post-menopausal women with serious vaginal dryness issues should strongly consider and estrogen cream, suppository, etc. They are very good on relieving vaginal symptoms but do not affect much else wheen applied locally.

    Here is a link to a Duavee article in the UK Telegraph, similar articles appear elsewhere. Despite Vivian’s use of a drug labels advisory of risks, I encourage you to appreciate that any drug, even the very best, will have a list of possibilities that will scare the bejesus out of you. Duavee and both of its separate components have been studied in thousands and thousands of women and the risk benefit profile speaks for itself. Please use your minds and your reasoning and most importantly, please look up and read about the science in medical journals, scientific journals or any other good source. Ultimately it will be your decision but try hard to dig in and don’t simply accept the words of the many non-espert expert’s out there, some of them are trying to do good, I do appreciate it but the ultimate truths are best found through your own diligent research and learning about the underlying science – its not always easy but it will be much more satisfying in the end and will also help you to make healthier choices. Sorry if I have offended anybody, I just get so upset when I see so much confusion and misunderstanding substituting for real analysis. Here’s the link: Best wishes to all, including Dr Vivian!

    http://www.telegraph.co.uk/health/healthnews/10390268/Potential-breakthrough-for-breast-cancer-treatment.html

    • DrChuckyHormoneSpecialistResearcher October 28, 2013, 8:34 pm

      More specifically and with regard to long bone fractures (atypical and bisphosphonates) the following provides a little needed balance and context to the alarmist take on these drugs. I kind of trust non-profit, independent organizations dedicated to improving the treatment of patients in a certain area. Not blindly of course but rather as sufficient to read their points and see if they make at least some logical sense.

      A working group of the International Osteoporosis Foundation and the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) have published a position paper on the association between subtrochanteric femoral (upper thigh bone) fractures and long-term treatment with bisphosphonates.

      The Position Paper’s key messages:

      Atypical fractures in association with bisphosphonate use are rare, estimated at one per 1,000 patients per year.
      Small clinical case reports and reviews have reported increased risk of these fractures among bisphosphonate users, but a large register-based study and restrospective analyses of phase III trials of bisphosphonates do not show an increased risk.
      More epidemiological research and well-designed studies are needed to clearly define and characterize atypical fractures and to learn about other risk factors in patients who have suffered these fractures.
      Available evidence shows the well-known benefits of bisphosphonate treatment far outweigh the relatively low risk of these rare, atypical fractures. For every 10,000 high-risk patients undergoing bisphosphonate treatment, approximately 100 hip fractures and 750 fractures at other sites are prevented, whereas only 3 to 6 atypical fractures could be expected.
      Patients should discuss any concerns with their doctors. Doctors should, as with all drug treatments, advise patients of any potential side effects or risks. Patients with pain in the hips, thighs or femur should be radiologically assessed, and examined for possible atypical subtrochanteric fracture. The radiographic changes should be examined for orthopaedic intervention or close monitoring. The decision regarding therapy should be based on an individual benefit-risk assessment.

  3. linda October 17, 2013, 2:38 am

    I have got rid of night sweats by taking a freezer pack to bed with me wrapped in a homemade cotton bag. I find that it cools me down so fast and I sleep better. It sure beats taking any of those chemical drugs with all the side effects.

    • Vivian Goldschmidt, MA October 17, 2013, 6:13 pm

      What a great idea, Linda!

  4. Nicole October 12, 2013, 9:01 pm

    Vivian – Can you tell me whether honey is good or bad for my bones. I know it’s loaded with sugar, therefore acidic, but I read a survey claiming honey is good for a host of things including bones. Since I don’t know who paid for the survey (maybe a group of beekeepers?) I am wondering whether I should or should not stay away from honey. Please advise. Thank you – Nicole

    • Vivian Goldschmidt, MA October 14, 2013, 1:37 am

      Nicole, honey is alkalizing and definitely has a place in a bone-healthy diet. All things in moderation, of course! But organic, raw honey can be used as a sweetener for foods like oatmeal or plain yogurt, or you can use it to sweeten herbal teas.

  5. Cindy October 11, 2013, 6:41 pm

    A while back you commented on Whey protein (Whey to go). I’ve been reading conflicting information regarding Whey protein. Some say bad for bones, can cause cramps, fatigue, etc. Also read that whey isolate is bad and whey concentrate is good..then read the other way around. Should I continue with Whey to go or stop using it? I’m so confused.

  6. Pearl October 11, 2013, 12:20 pm

    Thankyou Vivian, forewarned is forarmed, as I’m sure the Doctors will start pushing it at me when it is released.
    Very much appreciated.

  7. marlene October 11, 2013, 8:34 am

    Thank you from the bottom of our hearts for the work you do. What chemically destructive times we live in.This work and the stopping of hideous preservative chemicals in vaccines is extremely important work for our world.

  8. Elizabeth October 11, 2013, 7:14 am

    I now have refused to take Fosamax any more as I am
    a ‘Saver’. My G.P. tried quite hard to persuade me to take something else. But I was quite insistent. I have been on bio identical hormone therapy for many years .. NO estrogen. But progesterone in the form of a troche
    and contained therein is DHEA and pregnenolone. . I am 75 y.o. I firmly believe Bio identical hormones are safe.
    I would never take the other kind.

  9. Wadiah October 11, 2013, 1:37 am

    I’m a pharmacist. I went for my BMD test sometime in Mac this year & was confirmed to have osteoporosis & osteopenia in my spine & hip. I stopped taking protaxos after 6 wks (prescribed by my ortho surgeon) after joining Vivian’s progm..bcoz i too am not convinced of the drug. It’s so absurd to know that you can still hav a fracture despite taking the ‘osteoporotic drug’. I just took a repeat BMD test yesterday…..and walla ….i’m in the green already. It’s your body….you should be in control. Don’ let them make tons of money out of yr misery! Than you…..

  10. Carol October 11, 2013, 12:06 am

    I have been reading all your information and after talking with the Mayo clinic doctors about taking Fosamax 35mil. I have realized that you were only 50yrs old the natural bone strengthening you mention will work on someone that young, when we get in the late 60s this will not work anymore then you must have a supplement. The pharmacist I spoke to confirmed the same thing . I don’t want to break a hip so Iam going on the fosamax I know a lady that was on it for 25 yrs. She is fine. Your readers out there must realize you are selling books and tapes and whatever else . Please take me off your mailing list.

    • bob .. Retired Nurse. October 13, 2013, 2:49 pm

      Fosamax Does stop the deterioration of bones by stopping Apoptosis. .. ? Apoptosis is the death of old cells to make way for new cells. VIT E is critical in this process. So a person on Fosamax has bones that do not grow with the person But grow old much faster as they don’t have new cells . Just old and older cells protected by Fosamax. . As all the old cells in the bone that needed to die to be replaced with NEW bone Just stay as they are . Every part of our body must be replaced by new cells / tissues on a regular basis.

      • Vivian Goldschmidt, MA October 14, 2013, 1:31 am

        Exactly, Bob! The shedding of old bone cells is crucial to healthy bone remodeling.

    • Trudy October 11, 2013, 1:44 pm

      Carol, I am surprised you are so convinced about FOSAMAX. I was on it, then on ACTONEL (upgraded!) for nearly 6 years. Guess what, my bones deteriorated drastically (I took calcium + magnesium as well and exercised all my life!). The only thing that saved me was getting Vivian’s book and sticking to her advice re diet. My bones went from ‘high fracture risk’ to ‘minimal’ within 2 years. I think this is proof enough that these drugs don’t work. Apart from this, I lost a couple of teeth and developed brittle jaw bones (osteonecrosis of the jaw would have been next!). I suggest you do some more research on this issue. Your friend may just be one of the lucky ones who ‘got away with it’!
      Best of luck! Be safe!

  11. Sue October 10, 2013, 7:46 pm

    Vivian, What are your thoughts on the drug Zomeda. My husband is getting chemo for lung cancer. He also had tumors on a rib which they did radiation therapy on. The doctor now wants him to be infused with Zomeda to prevent more tumors in the bones and to strenghten the bones. I have osteoporosis and have refused any drugs. What should he do?

    • Bob ... Retired Nurse. October 13, 2013, 3:00 pm

      Dear Sue.
      I would love to read Vivien’s comments on the bones with this drug .

      On a more general look at Cancer etc . This publishing company has an editor
      “Le Fuller” that is committed to reviewing all articles. and he checks them out for truth . and the treatments quoted actually do work . Please go to their site . free emails . and many books and articles for sale. also many books have the names of medical clinics. doctors . Allopathic and Alternate and also some clinics not to go to. and reasons for that . You can do your own research and also contact medical specialists to help and treat . PS: I have no financial association …. “www.cancerdefeated.com”

  12. Terry October 10, 2013, 3:23 pm

    Vivian, thanks for keeping us updated on the latest drug info. I’m so grateful that you have your finger on the pulse of these releases. I used to trust everything that was told to me by physicians. While I still respect and appreciate their knowledge, I also know that I have to verify and check out all the drugs myself. Most of the time, the doctors only know what they have been told. They are not pharmacist!! So I keep asking questions and we work through this together. If it stops my body from doing what it naturally is supposed to do like remodeling….it’s not even on the table. If it’s going to cause cancer…it’s not on the table. I’ve lost too many loved ones and friend to that disease. Well, I’m running on again. Anyway, Thanks again. My best always!!

    • Trudy October 11, 2013, 1:51 pm

      Terry, the pharmacists will also convince you to take these drugs; It’s their business – been there, done that! They tell you that you have to take the good with the bad, unfortunately. Just reading about the side effects of all these osteo drugs makes me cringe!

  13. Vivian Goldschmidt, MA October 10, 2013, 2:43 pm

    I know that bio-identical hormones are very popular right now! But I am not convinced – they are still not safe, nor are they necessary to fight osteoporosis.

    I discussed bio-identical hormones in this blog post:

    http://saveourbones.com/the-one-osteoporosis-treatment-that-can-cause-breast-cancer/

    This topic was also addressed in question #3 of this Q&A post:

    http://saveourbones.com/vivian-answers-day-2/

  14. Wendy October 10, 2013, 2:42 pm

    Vivian could you please tell us your opinion on Bioidentical Hormone Replacement Therapy. Thank you.

  15. Connie October 10, 2013, 2:02 pm

    I am also on the Bio-identical hormones and so far, so good. I think it is helping my bones to become stronger and I also supplement with raw food vitamins and minerals. Hope Vivian will address this issue for us.

  16. Dr J.B. van Mourik, MD, PhD, Netherl.. October 10, 2013, 1:38 pm

    The use of bioidentical hormones, BHRT, is a safe and widely used, accep[ted therapy for women with postmenopausal complaints.
    There are thousands of women who uses it . Without any side effects, they are natural and without the side effects of HRT, that are medicines, not natural hormones.
    It are the same hormones your body always produced praemonopausal.
    For me it is very strange you don’t advice the use of it, are you not familiar with it.
    See A4M for example. anti-agingclinic.nl

    • Trudy October 11, 2013, 1:56 pm

      I am not familiar with those, heard/read about them, of course. Do they sell as pills/patches/creams? Do you need a script from your GP? Pls. let us know!
      Many thanks!

  17. Sondra Beam October 10, 2013, 1:36 pm

    I am currently on bio-identical hormone Estrodial patches and bio-identical progesterone cream for the sole purpose of treating my osteoporosis and menopausal symptoms. I have been contemplating going off of them worried that they might not be as safe as I have read. But from all the research I have done, by equalling out the ratios of both progesterone and estrodiol, and them being bio-identical too, this is the safest firm of BHRT. There are possible side affects, but by doing blood work and balancing the two ingredients both, you are safe. BUT …. PLEASE help Trudy and myself know if you know more about Bio-Identicals being a problem that we need to know about! HELP!

  18. Trudy October 10, 2013, 1:06 pm

    I was put on HRT initially because of my bone loss. It actually helped in conjunction with Vivian’s alkaline diet program to restore my bones. Since I have been off HRT patches, I have problems with insomnia and have to take tranquilizers (won’t take sleeping pills) to get a few hours sleep per night. Most nights I still wake up after 3 hours sleep, which is obviously not enough for the body to regenerate. I often feel terrible, like hungover, when I have to go to work. Some days I feel like going back to the HRT patches despite the ‘downside’, just to get some decent sleep. I am a fit, slim, active person, still swim 2Km a few times a week and go walking – no couch potato! I stick to a healthy diet (Vivian’s diet plan). Why can’t I sleep although I am tired? I am 64 years old. Any advice apart from drinking camomile tea, which does not help either?

    • Bob ... Retired Nurse. October 13, 2013, 3:11 pm

      Cannot sleep. Such a common problem …. Please search around for someone that will help you in the day to day of preparation of sleep. It could easily be you mind that has too strong a desire to sleep that it is counter productive. Some drugs and some foods taken at night prevent a good sleep. Tranquilizers help with some forms of pain but are not the answer for sleep. Sleeping pills etc have a short life of 4 / 5 hours and they wear off suddenly . so most likely have set up a pattern that you must break.

  19. Fenella Pearson October 10, 2013, 12:59 pm

    Bioidentical hormone replacement therapy is safe, because they are the exact same hormones that women make naturally. I would not touch these synthetic chemicals with a barge pole on account of the horrific side effects.

    • Bob... Retired Nurse.. October 13, 2013, 3:19 pm

      HRT . ??? where do they get it from ??? Equine estrogen .??? To put it bluntly . Collected from farmed horses urine. True.. Horses bodies are not compatible with humans. Even in The scriptures of the Jews. “Old Testament. eat only that meat etc that comes from cloven hooves. . sheep. cow etc. a Horse has a solid hoof. Their meat is strong and very hard to digest . the blood is technically incompatible with human blood. SO why do they use Horses urine to collect Equine estrogen when there are plants than humans can use for the body to make hormones. ?? $$$$$$

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