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Karma

Menopause: Paxil Repackaged, Renamed -- Another Deception!

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Karma

Saw this on the news tonight and looked up an article on it.  On Friday the FDA approved Brisdelle for moderate to severe hot flashes.  Brisdelle is low dose paroxetine or Paxil. 

 

The committee that studied it recommended against approving it ... but the FDA thought it was a good idea.

 

This is marketed to women who are afraid of cancer due to hormone replacement therapy - I wonder if they bother to tell the patients that there is a risk of withdrawal syndrome when they no longer have hot flashes. 

 

 

http://articles.latimes.com/2013/jun/28/science/la-sci-fda-antidepressant-hot-flashes-20130628

 

I think this is a really BAD idea.  I predict that over some time we will see more visitors to our site looking for help getting off of Brisdelle ... very sad.

 

Karma

 

 

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Altostrata

I agree, a really bad idea!!!!!

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Jemima

What a shame!  Vitamin E takes care of a lot of menopausal symptoms with few to no side effects.  In any event, I'd strongly prefer hot flashes  to cancer-causing hormones or God-knows-what-causing antidepressants.

 

Good catch, Karma.  I hope a lot of women see this post before they try Brisdelle.

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Karma

The problem with those studies on hormone replacement therapy that report increased cancer risk is that they used the pharmacuetical versions of the hormones like Premarin which is made from pregnant mare's urine or synthetic progestin ... those hormones are foreign to the human body ... the "bioidentical" hormones have the same molecular structure as hormones produced naturally by the body. These studies were not performed on what we term "bioidentical" hormones.  Scientific evidence suggest that "bioidentical" hormones do not increase the risk of cancer and can actually provide other health benefits ... such has helping to maintain bone density.

 

Here is an article on LEF (Life Extension Foundation) that discusses the difference in pharmacuetical versions and what are termed "bioidentical" hormone replacement therapy.

 

http://www.lef.org/magazine/mag2009/oct2009_Bioidentical-Hormones_01.htm - if you print the article as a pdf you will find the studies referenced at the end of the article.

 

Karma

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NewMe

Seems big pharma is at it again. Brisdelle is FDA approved for treating hot flashes. A pretty commercial touting the benefits - appealing to women experiencing hot flashes. 

 

What is Brisdelle? For starters, it is made by Noven Therapeutics, LLC

 

Neatly camouflaged in the commercial is the generic name you may recognize: PAROXETINE. AKA: Paxil - an SSRI

 

Effexor has been "repurposed"  for treating hot flashes as well. Now Brisdelle. 

 

 

Sure - call it "repurposing" ssri's. Sounds more green doesn't it?

 

FDA approved for hot flashes. $$$$$$$$$$$$$$$

 

Non-hormonal treatment indeed! There is nothing hormonal about it, much less any logic.  Read about the press release here between NOVEN and Shionogi Inc. to co-promote Brisdelle™:

 

 

 
Hooking women in meno (and peri) on a psych drug that comes with DS, numerous possible side effects including possible suicidal feelings...all for reducing hot flashes. It is a psych med. As if meno and peri meno are not challenging enough.

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Altostrata

Yep, it's low-dose Paxil.

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NewMe

Permit me to add that with a tiny bit of digging that the FDA panel advised AGAINST approval of Brisdelle for hot flashes. True, FDA does NOT have to follow the panel's majority vote, but why did they overtake the decision and pass it? Seems to me the FDA as a whole is becoming cocky in the name of using  for confetti. Such wanton abuse of power is akin to committing crimes without apology as the world watches. 

 

Who funded the drug study???

Interesting blog

...Brisdelle Background

Noven Pharmaceuticals makes Brisdelle and funded the studies on the use of Brisdelle to treat hot flashes. Dr. James A. Simon, Clinical Professor of Obstetrics and Gynecology at the George Washington University School of Medicine in Washington DC, led the study. Dr. Simon openly reports having a financial relationship with Noven. The fact that Noven supported the study and provided the drug for the study, along with the fact that the lead doctor overseeing the study has financial ties with Noven, is troubling in my opinion, but standard fair in pharmaceutical research....

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Karma

According to ANH-USA 60% of the FDA's funding comes from pharmaceutical companies. 

 

In my humble opinion the FDA has no interest in protecting consumers, but rather only in protecting their major source of funding.

 

Karma

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Altostrata

Phone the FDA 1-800-332-1088 and press #4 to speak to a representative and make a complaint.

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Rhiannon

Starting in about the Bush 1 administration, the FDA was taken over by pharmaceutical industry insiders, and the fox has been the one guarding that particular henhouse for quite a few years now. Which explains quite a few things, including this, and direct-to-consumer advertising (one of the worst ideas ever, for patients, but a great idea for industry profits.)

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Altostrata

Please phone the FDA anyway, or we're only talking to ourselves.

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MollyN

Nooooooo!!! This is scary!! I might have taken this and then when I stopped just thought menopause was being hideously tough on me, this is miserable.

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cymbaltawithdrawal5600

Do you have "pill pushing advertising" in NZ like we do here? That's how I first heard about it. Started screaming "Nooooooooooooooo"! the moment I heard it the first time. Very sad.

 

I heard the disclaimer about "suicidal thoughts" and that pricked up my ears. A quick google search confirmed my fears. What a load of crap.

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westcoast

Does anyone remember the anti PMS drug that was actually Prozac with a different name? I haven't seen an ad for it in years. People don't talk about PMS as much as they used to.

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cymbaltawithdrawal5600

Oh for pete's sake, really?

 

Yep, this first page of google results has an entry about using the big P for it as recently as 12/14 (from Bristol U in the UK)

 

"Sarafem" maybe?

 

I am so glad I was never taken in by a lot of marketing hype (except I fell hook line and kitchen sink for the line about 'needing an AD for the rest of my life'). My menopause was very unremarkable and was over in less than a year. Can't even remember hot flashes. (Remember ads that used Lauren Hutton to push something for it, a hormone? I googled it and saw this blurb about her being called "The Poster Child for Menopause"  in a synopsis for search results. That stuff turned out to be not so good an idea). Had something like them last year during protracted wd but they were a sx of 'autonomic dysfunction' not true hot flashes of the post meno type.

 

Capitalism has some minefields......

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