The New FDA Approved Osteoporosis Drug
by Vivian Goldschmidt, MA
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?
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 [HRT] 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
- Upper abdominal pain
- Throat pain
- 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, and bioidentical natural progesterone as described in www.HealthyHormones.com
FDA Approves Duavee 2013
FRIDAY, Oct. 4 (HealthDay News) — Pfizer Inc. says it has gained U.S. capitulation for a drug designed to provide menopause-related prohibited flashes and potentially forestall osteoporosis in postmenopausal women who have a uterus.
The United States is a initial nation to approve a once-a-day inscription called Duavee (conjugated estrogens/bazedoxifene), according to Pfizer. When prescribed usually for a impediment of osteoporosis in postmenopausal women, use of Duavee should usually be deliberate for women during poignant risk, and non-estrogen remedy should be deliberate first, a drug builder advised.
The U.S. Food and Drug Administration’s capitulation was formed on proviso 3 clinical trials that enclosed generally healthy, postmenopausal women with a uterus. One investigate found that women holding a drug had 74 percent fewer moderate-to-severe prohibited flashes after 12 weeks of treatment, compared with a 47 percent rebate among women who took a placebo, Pfizer pronounced in a news release.
In other trials, women who took Duavee showed increasing levels of bone vegetable firmness in a hip and lumbar spine after one and dual years of treatment, while women in a remedy organisation had decreased levels, a drug association said.
Common side effects of Duavee embody flesh spasms, nausea, diarrhea, dissapoint stomach, abdominal pain, throat pain, nausea and neck pain, according to Pfizer.
Pfizer pronounced that Duavee should not be used by women who: have or have had blood clots; are allergic to any of a ingredients; have surprising vaginal bleeding; have or have had certain cancers (e.g. uterine or breast), liver problems, or draining disorders; or are pregnant, might turn profound or are breast-feeding.
Estrogen and drugs like bazedoxifene can boost a risk of blood clots. Women should speak with their alloy about how prolonged to stay on Duavee, Pfizer said.
One consultant pronounced women should import their options delicately before selecting to take a drug.“Duavee should be used with caution, and usually for a shortest time possible,” pronounced Dr. Jennifer Wu, an ob/gyn with Lenox Hill Hospital in New York City. “No hormone deputy is dictated for a prolonged term.” “Uterine cancer might still be a risk when regulating a estrogen,” Wu added. “Longer tenure studies are needed.”
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