Duavee is used for the treatment of moderate-to-severe hot flushes due to the menopause and the prevention of postmenopausal bone loss. But before you ask your doctor about Duavee… there’s a few things you need to know and chances are, after reading this alert, you probably won’t want to ever consider this drug as an option to treat hot flushes or postmenopausal bone loss.
Different name, same drug
Somehow, the drug giant Pfizer managed to get Duavee approved by the American Food and Drug Administration (FDA) in October last year.
I say ‘somehow’ because the first thing that signalled a problem with this drug was when I read this: ‘DUAVEE should be taken for the shortest time possible and only for as long as needed. For prevention of bone loss alone, talk to your doctor about whether a different treatment without oestrogens might be better for you.’
Now as far as warnings go, that’s not exactly straightforward… but then again, when you deal with Big Pharma nothing ever is.
See, Duavee used to be called Aprela – a synthetic hormone replacement drug that had been around since the late 90s. The dangers of hormone replacement therapy became known shortly after Aprela hit the market and by 2002 the Women’s Health Initiative proved how incredibly dangerous oestrogen drugs really are – they significantly increase the risk of breast cancer, strokes and heart attacks.
So, why on earth would the FDA approve another oestrogen drug… especially if it is the same drug (with the same risks!) only with a different name?
That’s because Pfizer wants us to believe (and they’ve clearly convinced the FDA) that this ‘new’ drug is somehow safer than the old oestrogen drugs… despite fudged studies, horrific side effects, missing reports, lacklustre data and the fact that the FDA has yet to approve the second half of this drug combo.
Duavee is a mixture of oestrogen drugs and a drug called bazedoxifene. Bazedoxifene comes with its own horrible side effects – stroke, blood clots, hot flushes (unbelievable!), leg cramps and cancer.
Bazedoxifene is also known as Viviant – a drug Pfizer has been trying to get approved by the FDA for osteoporosis since 2006 without success because of safety concerns. Pfizer has yet to address the FDA’s ‘concerns’ about its safety.
However, instead of addressing these safety concerns, Pfizer came up with the clever plan to mix up this lethal concoction of dangerous drugs, call it Duavee, and tell the FDA it’s a ‘new and improved’ version. Oh yes, and just to cover their tracks Pfizer has already set aside over $800 million to cover future lawsuits.
Voila! Another VERY dangerous drug approved! But not before the FDA told Pfizer that the usual way ‘adverse events’ are reported will not be enough for this perilous drug. To figure out the ‘serious risk’ it might pose for cancer of the uterus, Duavee will require a full-scale ‘clinical trial.’ One to be reported back to the FDA over a year from now!
In the meantime, the FDA was so ‘kind’ as to stick a Black Box warning on Duavee, warning about cancer, heart damage and ‘probable dementia’!
So, to be clear:
To treat moderate-to-severe hot flushes with Duavee, you’ll be taking a drug that has not yet been fully approved, not enough is yet known about how many cancers it might cause… and in addition you also run the risk of developing heart damage, stroke and dementia.
What? To treat hot flushes?
Yes, they can be horrible. But they are temporary. And they are certainly not dangerous. Most importantly, they will stop.
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Disclaimer: Bear in mind the material contained in this article is provided for information purposes only. We are not addressing anyone’s personal situation. Please consult with your own physician before acting on any recommendations contained herein.
Letter, FDA to Birming Wong, Pfizer, October 3, 2013, accessdata.fda.gov
‘Big Pharma wins again: FDA approves Aprela under new name’ Jane Allin, November 8, 2013, Tuesday’s Horse, tuesdayshorse.wordpress.com
‘Pfizer targets approval for new menopause drug’ Ryan McBride, FierceBiotech, fiercebiotech.com
‘In Illinois deal, the Onion will promote health insurance (really)’ Scott Hensley, February 11, 2014, NPR, nor.org