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Pfizer Pulls US Bid To Push Pristiq for Menopausal Symptoms


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http://www.nasdaq.com/article/pfizer-pulls-us-bid-to-market-antidepressant-to-treat-menopausal-symptoms-20120229-01034

 

Pfizer Pulls US Bid To Market Antidepressant To Treat Menopausal Symptoms

 

By Peter Loftus, Of DOW JONES NEWSWIRES Feb 29, 2012

 

Pfizer Inc. (PFE) has withdrawn an application seeking U.S. regulatory approval to market its antidepressant Pristiq as a treatment for certain menopause-related symptoms in women.

 

The U.S. Food and Drug Administration in September declined to approve Pfizer's bid to expand the drug's uses to include relief of moderate-to-severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.

 

The New York drug maker withdrew its FDA application earlier in February, Pfizer said in an annual report filed Tuesday with the Securities and Exchange Commission.

 

"While our voluntary withdrawal of the Pristiq application for a [vasomotor symptoms] indication is a disappointing development, the health and well-being of women remain important focuses for Pfizer," said Pfizer spokesman MacKay Jimeson.

 

Pristiq was approved in the U.S. in 2008 as a treatment for major depressive disorder in adults. The drug also has been approved in some countries outside the U.S., including Mexico, to treat menopausal symptoms. The drug remains on the market for its approved uses.

 

Pfizer inherited Pristiq with its 2009 acquisition of Wyeth.

 

Wyeth first filed for FDA approval of Pristiq to treat menopausal symptoms in 2006. The agency in 2007 requested an additional safety study of the drug, the results for which Pfizer submitted to the FDA in December 2010. The FDA sent Pfizer a "complete response letter" in September 2011, which meant the application couldn't be approved in its current form.

 

....

The drug generated sales of $577 million for 2011, up 24% from 2010. Wyeth executives once predicted Pristiq could generate more than $2 billion in annual sales, but it has fallen short partly due to a crowded antidepressant market and the lack of an approved indication for menopausal symptoms.

 

Pfizer is hoping to seek FDA approval for another drug obtained in the Wyeth deal, Aprela, to treat menopausal symptoms.

....

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

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Well, thank God for this. I was on Pristiq for five months and I can't recommend it for anything but poisoning somebody. (A rat wouldn't hold still long enough to swallow it, and ants are too smart to try.) It made me so tense and hyper I don't have the words to describe the experience. Poison, pure poison. I never had very bad problems with menopause, but I can imagine Pristiq driving someone who does right over the edge.

 

Where, of course, a psychiatrist will be waiting with prescription pad in hand.

Psychotropic drug history: Pristiq 50 mg. (mid-September 2010 through February 2011), Remeron (mid-September 2010 through January 2011), Lexapro 10 mg. (mid-February 2011 through mid-December 2011), Lorazepam (Ativan) 1 mg. as needed mid-September 2010 through early March 2012

"Never attribute to malice that which is adequately explained by stupidity." -Hanlon's Razor


Introduction: http://survivingantidepressants.org/index.php?/topic/1588-introducing-jemima/

 

Success Story: http://survivingantidepressants.org/index.php?/topic/6263-success-jemima-survives-lexapro-and-dr-dickhead-too/

Please note that I am not a medical professional and my advice is based on personal experience, reading, and anecdotal information posted by other sufferers.

 

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I knew you would like this one, Jemima.

 

Prescribing antidepressants to menopausal women -- how stupid is that? Is this a demographic that really needs increased risk of sexual dysfunction, diabetes, stroke, osteoporosis? And withdrawal syndrome? Is the plan to keep them on the drugs until they die? (Yes.)

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

All postings © copyrighted.

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It really combs my fur the wrong way to see that most of these drug misuses are directed at women. Since when does menopause require medical intervention? Is just being an outspoken woman a problem?

 

I AM WOMAN - HEAR ME ROAR!

 

And if that makes some "professionals" wet their pants, well, too bad. I have always thought the world would be a better place if Adam had just dropped dead after he bit into the apple.

Psychotropic drug history: Pristiq 50 mg. (mid-September 2010 through February 2011), Remeron (mid-September 2010 through January 2011), Lexapro 10 mg. (mid-February 2011 through mid-December 2011), Lorazepam (Ativan) 1 mg. as needed mid-September 2010 through early March 2012

"Never attribute to malice that which is adequately explained by stupidity." -Hanlon's Razor


Introduction: http://survivingantidepressants.org/index.php?/topic/1588-introducing-jemima/

 

Success Story: http://survivingantidepressants.org/index.php?/topic/6263-success-jemima-survives-lexapro-and-dr-dickhead-too/

Please note that I am not a medical professional and my advice is based on personal experience, reading, and anecdotal information posted by other sufferers.

 

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Two-thirds of antidepressants are prescribed to women. Women are very easy to convince they need fixing.

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

All postings © copyrighted.

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I cannot see how Pristiq could help menopausal women when it has made me sweat profusely every night!

I am so tired of waking up drenched and cold every day.

I cannot wait for this venom to be out of my system!

Rosie

2009 Efexor 75mg tapered twice

November 2011 Pristiq 50 mg

January 2012 Pristiq 100 mg, became very dizzy and anxious with a lot negative thinking! Ear aches, eye pain, headaches, bruxism, night sweats.

Currently on 30 mg of compounded Pristiq

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YEAH!!!!!

 

This push to treat everything hormonal as psychiatric is infuriating! Yesterday I read several articles about classifying PMDD as a psychiatric disorder to be included in DSM-V. Normal hormonal fluctuations should not be treated with a drug that disrupts hormones. Am I missing something? Why are the primary hormonal issues not even looked at? A microdose of natural hormone for a few days/month must be safer than ADs.

This hits too close to home for me.

Pristiq tapered over 8 months ending Spring 2011 after 18 years of polydrugging that began w/Zoloft for fatigue/general malaise (not mood). CURRENT: 1mg Klonopin qhs (SSRI bruxism), 75mg trazodone qhs, various hormonesLitigation for 11 years for Work-related injury, settled 2004. Involuntary medical retirement in 2001 (age 39). 2012 - brain MRI showing diffuse, chronic cerebrovascular damage/demyelination possibly vasculitis/cerebritis. Dx w/autoimmune polyendocrine failure.<p>2013 - Dx w/CNS Sjogren's Lupus (FANA antibodies first appeared in 1997 but missed by doc).

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I knew you would like this one, Jemima.

 

Prescribing antidepressants to menopausal women -- how stupid is that? Is this a demographic that really needs increased risk of sexual dysfunction, diabetes, stroke, osteoporosis? And withdrawal syndrome? Is the plan to keep them on the drugs until they die? (Yes.)

 

 

I think this white male world would very much like to stifle us. Well, HELLO! and too bad!

Psychotropic drug history: Pristiq 50 mg. (mid-September 2010 through February 2011), Remeron (mid-September 2010 through January 2011), Lexapro 10 mg. (mid-February 2011 through mid-December 2011), Lorazepam (Ativan) 1 mg. as needed mid-September 2010 through early March 2012

"Never attribute to malice that which is adequately explained by stupidity." -Hanlon's Razor


Introduction: http://survivingantidepressants.org/index.php?/topic/1588-introducing-jemima/

 

Success Story: http://survivingantidepressants.org/index.php?/topic/6263-success-jemima-survives-lexapro-and-dr-dickhead-too/

Please note that I am not a medical professional and my advice is based on personal experience, reading, and anecdotal information posted by other sufferers.

 

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The mostly white, mostly male world of pharmaceutical marketing has made billions playing on women's fears.

 

I'm with you, we should be up in arms about that.

 

I agree, Barb, prescribing hormonal disruptors to women whose hormones are already unstable is incredibly stupid. But doctors don't see psychiatric drugs as hormonal disruptors, although they clearly are.

This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

All postings © copyrighted.

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And so much easier to use since no labs or levels are involved ~

Looking at primary hormones would involve an understanding of physiology and science ~

Pristiq tapered over 8 months ending Spring 2011 after 18 years of polydrugging that began w/Zoloft for fatigue/general malaise (not mood). CURRENT: 1mg Klonopin qhs (SSRI bruxism), 75mg trazodone qhs, various hormonesLitigation for 11 years for Work-related injury, settled 2004. Involuntary medical retirement in 2001 (age 39). 2012 - brain MRI showing diffuse, chronic cerebrovascular damage/demyelination possibly vasculitis/cerebritis. Dx w/autoimmune polyendocrine failure.<p>2013 - Dx w/CNS Sjogren's Lupus (FANA antibodies first appeared in 1997 but missed by doc).

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