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US regulators to decide on 'female Viagra'
medicalxpress.com ^ | August 18, 2015 | Staff

Posted on 08/18/2015 1:36:22 PM PDT by Red Badger

US regulators are expected to decide Tuesday whether to approve a drug nicknamed the "female Viagra," which would be the first pill on the market to raise women's sex drive.

In June, an advisory panel to the Food and Drug Administration urged regulators to approve the drug, flibanserin, after previously voting against it twice in years past.

This time, the experts voted 18-6 in favor of allowing the drug on the market, but with some additional risk-control measures to make sure doctors prescribe it only to patients who need it and that women are aware of the risks.

The FDA is not required to follow the advice of the panel, but it often does.

A spokeswoman for Sprout Pharmaceuticals in North Carolina told AFP that the FDA decision was expected Tuesday but was unsure what time. An FDA spokeswoman declined to comment.

If approved, flibanserin would be sold under the name "Addyi," and marketed toward pre-menopausal women.

It can have significant side effects including nausea, dizziness and sleepiness.

Safety concerns include sleepiness, fainting, low blood pressure and the potential for hormonal contraceptives and alcohol use to make side effects worse.

Experts also raised questions about the increased risk of breast cancer seen in one of two studies on lab animals.

Most commonly diagnosed disorder

The drug is a non-hormonal agent that acts on neurotransmitters in the brain, and aims to treat a condition known as hypoactive sexual desire disorder (HSDD), or loss of interest in sex, among women who have not yet entered menopause.

Rebecca Zucconi, an assistant professor of medical sciences at the Frank H. Netter School of Medicine at Quinnipiac University, said the condition is the most commonly diagnosed sexual dysfunction in women.

"Until now, physicians have been limited to recommending education, counseling, psychotherapy and, in some cases, off-label usage of testosterone and estrogen therapy as treatment options for otherwise healthy women with HSDD," Zucconi said.

"Importantly, the advisory panel gave its approval with specific concerns regarding flibanserin's safety when combined with certain medications or with alcohol.

"If approved by the FDA, flibanserin will likely be marketed and prescribed with explicit restrictions to this effect."

Two attempts at bringing the drug to market failed in 2010 and 2013, given what experts described as inconclusive advantages when compared to a placebo.

According to documents on the FDA website, women taking flibanserin reported on average 4.4 sexually satisfying encounters per month, compared to 3.7 in a placebo group and 2.7 before beginning the study.

Explore further: FDA schedules meeting on twice-rejected female libido drug


TOPICS: Business/Economy; Culture/Society
KEYWORDS: flibanserin; vergara; viagra
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To: nascarnation
She so horny!
For the last couple of days I have just loved using this clip!


21 posted on 08/18/2015 2:06:57 PM PDT by Gamecock (Many Atheists: "There is no God and I hate Him!")
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To: the OlLine Rebel

“It can have significant side effects including nausea, dizziness and sleepiness.”

My wife doesn’t need to take a pill to get those symptoms.


22 posted on 08/18/2015 2:08:53 PM PDT by EQAndyBuzz ("Hillary, you magnificent b**ch! I read your book!")
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To: Gamecock

LoL?


23 posted on 08/18/2015 2:10:11 PM PDT by NoDRodee (U>S>M>C)
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To: EQAndyBuzz

Neither do I.

OTOH, I am taking many pills of different kinds for many years now, so maybe that is why....


24 posted on 08/18/2015 2:14:23 PM PDT by the OlLine Rebel (Common sense is an uncommon virtue./Federal-run medical care is as good as state-run DMVs.)
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To: Red Badger

this may lead to an epidemic of world-wide nymphomania (a product of the brain’s pleasure center)


25 posted on 08/18/2015 2:15:39 PM PDT by elpadre (AfganistaMr Obama said the goal was to "disrupt, dismantle and defeat al-hereQaeda" and its allies.)
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To: Gamecock

Why did you have to post that - I was eating. Eeeeww!


26 posted on 08/18/2015 2:17:50 PM PDT by Diamond (He has erected a multitude of new offices, and sent hither swarms of officers to harass our people,)
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To: Slyfox

“It can have significant side effects including nausea, dizziness and sleepiness.”

I think most of us would rather fake it than take it. :-)


27 posted on 08/18/2015 2:18:02 PM PDT by Georgia Girl 2 (The only purpose o f a pistol is to fight your way back to the rifle you should never have dropped.)
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To: Red Badger

Well scientists discovered decades ago a substance which reduces the libido of women by over 95 percent.

Wedding cake.


28 posted on 08/18/2015 2:23:35 PM PDT by mkjessup (Iran has an ayatollah for it's 'supreme leader', America has an ASSAHOLLAH !!!)
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To: Tired of Taxes

How did Bill Cosby vote?


29 posted on 08/18/2015 2:30:54 PM PDT by MNDude (God is not a Republican, but Satan is certainly a Democrat.)
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To: Gamecock

THAT JUST TOOK 6 OF MY 9 LIVES.

30 posted on 08/18/2015 3:08:06 PM PDT by seawolf101
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To: yarddog

Only the misinformed men think that.


31 posted on 08/18/2015 3:25:41 PM PDT by Bigg Red (Let's put the ship of state on Cruz Control with Ted Cruz.)
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To: Gamecock

Good grief! Is that really Hillary? Where was this?


32 posted on 08/18/2015 3:27:18 PM PDT by Bigg Red (Let's put the ship of state on Cruz Control with Ted Cruz.)
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To: Gamecock

You’ve done enough. Have you no sense of decency, sir, at long last? Have you left no sense of decency?


33 posted on 08/18/2015 3:31:50 PM PDT by Dagnabitt
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To: Gamecock

She could ride that rear end around Churchill Downs!


34 posted on 08/18/2015 3:40:28 PM PDT by Dr. Ursus
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To: Bigg Red

Yup. South Africa.

Google Hillary Bump and Grins.

I would post it but I am on my phone right now.


35 posted on 08/18/2015 3:42:18 PM PDT by Gamecock (Many Atheists: "There is no God and I hate Him!")
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To: Yo-Yo

My first wife had a hysterectomy when she was 25. For a short time she was on testosterone. Had a blue pill for low dose. Red pill was “medium dose”. Or so they said. What I said was “Don’t take the red pill!!!” I’m pretty sure she would hump a tree after taking the red one.

That was in the early 80’s. So this type of thing has been around for quite a long time.......


36 posted on 08/18/2015 3:55:53 PM PDT by saleman (?)
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To: Gamecock

That’s okay; seeing the clip you posted was scary enough.


37 posted on 08/18/2015 4:05:04 PM PDT by Bigg Red (Let's put the ship of state on Cruz Control with Ted Cruz.)
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To: Slyfox

“I wish I could remember exactly what the problems were but they were minimal. Because they interfered with the pleasure aspect for the man,”

I call BS. The problem is that stopping sperm production becomes final. Going off the male pill doesn’t restore fertility. A woman can go off the pill and usually go right back to normal.
That story is just RadFem propaganda.


38 posted on 08/18/2015 4:29:06 PM PDT by DesertRhino (I was standing with a rifle, waiting for soviet paratroopers, but communists just ran for office)
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To: the OlLine Rebel

“Exactly. Can’t stop men’s pleasure - including insurance/Obamacare paying for it as if it were necessary for life.”

Well God forbid a male have any pleasure. And last I checked, birth control is designed to impede a normally functioning system, yet women have no problem demanding that get paid for.

“Maybe finally we can have something to get us in the mood again.”

Women’s problem with libido is usually psychological, or simply a bad attitude in most cases. Viagra addresses a physiological problem in a male.


39 posted on 08/18/2015 4:34:43 PM PDT by DesertRhino (I was standing with a rifle, waiting for soviet paratroopers, but communists just ran for office)
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To: DesertRhino; the OlLine Rebel
last I checked, birth control is designed to impede a normally functioning system, yet women have no problem demanding that get paid for.

Not the women on this forum.

40 posted on 08/18/2015 8:19:49 PM PDT by Tired of Taxes
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