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Bitter Cactus
reformed bad boy


Registered: 01/26/12
Posts: 11,773
Loc: Alberta, Canada
Last seen: 8 years, 4 months
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FDA panel recommends approval of ‘female Viagra’
#21776344 - 06/07/15 10:08 PM (8 years, 7 months ago) |
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WASHINGTON — The first “female Viagra” came one step closer to coming to market as a key advisory committee to the Food and Drug Administration voted Thursday afternoon to recommend that the FDA approve the drug with conditions.
The committee voted 18-6 to recommend that the FDA approve flibanserin, a drug designed to boost the low sexual desire of otherwise healthy women.
The FDA usually follows the recommendations of its advisory committees, but not always. Its decision is expected by the end of the summer. The agency has already rejected the drug twice, saying the potential side effects of fainting, nausea, dizziness, sleepiness and low-blood pressure outweighed its benefits.
Even on Thursday, the committee described the drug benefit as “moderate” or “marginal.”
But after an afternoon of emotional testimony from women who suffer from low sexual desire, a condition called Hypoactive Sexual Desire Disorder, the majority of committee members said that, with proper warning labels and education, the drug should be made available to women who now have nothing.
One practitioner said that when her patients asked her for help, “This is all I can tell them.” And then she stood in front of the microphone in silence for several uncomfortable minutes.
Some of the women speaking Thursday described the condition as if a switch had gone off, they don’t understand why they no longer want to have sex, and find it distressing.
Before a packed hearing room, Sprout Pharmaceuticals, developers of the drug, presented the results of a series of double-blind clinical trials that showed the drug worked better than placebo to boost women’s sexual desire, increased the number of sexually satisfying events and lowered women’s distress at the loss of their libido.
Allen G. Breed / Associated Press Allen G. Breed / Associated PressCindy and Robert Whitehead, co-founders of Sprout Pharmaceuticals, at its headquarters in Raleigh, N.C., in 2013. Related Drug to boost women’s sex drive struggles for government approval as debate rages over need for it Overworked and undersexed: Job stress can affect your libido — and that’s bad news for your health Sexless marriages are a ‘silent epidemic,’ but it doesn’t have to be that way, U.K. therapist argues After 24 weeks, they said, 46 to 60 percent of the women in the trials had benefited from the flibanserin treatment. But some committee members said, after adjusting the data to take the placebo effect into account, the drug wound up helping only about 10 percent of the women in the trials.
More than half the women diagnosed with low sexual desire have turned in desperation to unproven, unregulated and potentially unsafe treatments they read about on the Internet or in magazines, which could pose health risks, the pharmaceutical company presenters said. Some of those testifying were health-care practitioners who said many women have turned to such “snake oil” with dangerous results.
Although the FDA approved Viagra for men in 1998, and a host of products since then, the FDA has not okayed any medications for women’s sexual function. The FDA describes this as an “unmet medical need.” Flibanserin, first developed as an anti-depressant, works on neurotransmitters in the brain that afffect sexual desire.
In their presentation, FDA medical officers outlined a host of safety concerns about the drug and raised the question of the day: Whether the risks of the side effects outweighed the benefit of the drug.
The most common side effects include dizziness, nausea, fainting and sleepiness. Some women had to stop taking the drug because of the side effects, and one reacted so poorly that she had to be hospitalized.
FDA officials are concerned about flibanserin’s interaction with other drugs — particularly with hormonal birth control pills and alcohol — and the potential for flibanserin to increase accidents, from car accidents to falls and other mishaps.
Some committee members were also worried about one two-year cancer study that found an increased risk in breast cancer tumors in mice that were given four times the therapeutic dose of 100 milligrams daily. One advisory panel called the potential link to cancer a “show stopper.”
FDA officials said most flibanserin trials lasted one year to 18 months. “That, in our opinion, is not enough to assess the risk of cancer development,” one official said. Sprout officials explained that increased tumors in one sex in animal studies have not been found to predict cancers in humans.
Another member of the panel raised concern that the drug could be used as a “date rape” drug. The drug maker said that the drug was slow-acting and could make women sleepy, but not incapacitated.
After the vote, which many said was “difficult,” the advisory committee began to work on conditions that they would recommend accompany any FDA approval, including warning labels, an education program, prescriber training and certification. They are most concerned that the drug not be used with alcohol, with certain drugs, or by pregnant women.
Some panel members who voted against approval said that the data wasn’t good enough, and the benefits weren’t strong enough to warrant approval, given the side effects.
“I recognize people are suffering,” said Diane Aronson. “I just think they deserve better.”
Some speakers urged the committee members to reject the drug. Some said that while the condition of low sexual desire was real and painful, flibanserin wasn’t the answer. They said the drug’s success was due more to a slick marketing campaign put together by Sprout than to good science.
Others warned that the pharmaceutical company had “deceived women into taking a drug that doesn’t work better than drinking a glass of wine or two, and could end up killing us,” said Liz Canner, a film maker who produced the documentary, Orgasm, Inc., about the medical communities quest for female viagra and the big bucks that could ensue.
Sally Greenberg, executive director of the National Consumers League,said she spent the day talking with women diagnosed with low sexual desire who are pushing for a treatment.
“It’s very destructive to their relationships, to their families and their self image,” she said. “We know this is a problem with their brain chemistry. Just like depression. And, just like depression, their brain chemistry can be adjusted. We can treat it. And we should treat it.”
To Greenberg, the committee vote was a historic moment. “I think this is a huge moment for women’s sexual health, in the way that the pill was for women’s sexual health and ability to control their own destiny,” she said.
Discuss
-------------------- Taking acid and thinking you are a better man is a lot different then actually becoming a better man.
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larry.fisherman
shoulda died already



Registered: 11/03/12
Posts: 36,294
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: Bitter Cactus]
#21776346 - 06/07/15 10:10 PM (8 years, 7 months ago) |
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Cocaine works too.
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Bitter Cactus
reformed bad boy


Registered: 01/26/12
Posts: 11,773
Loc: Alberta, Canada
Last seen: 8 years, 4 months
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: larry.fisherman]
#21776350 - 06/07/15 10:10 PM (8 years, 7 months ago) |
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Quote:
XLCaps said: Cocaine works too.
Ya but dude imagine the potential of this. Sluts will be slutting so much harder.
-------------------- Taking acid and thinking you are a better man is a lot different then actually becoming a better man.
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jboredone
Money-The root of all evil....



Registered: 01/19/12
Posts: 4,783
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: larry.fisherman]
#21776351 - 06/07/15 10:11 PM (8 years, 7 months ago) |
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was gonna say mdma....
-------------------- Peace Pot Micro-Dot God Loves You High or Not!!! In order to grow old and wise, you must once have been young and dumb!

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TheMovement
faeirie princess in training



Registered: 07/30/12
Posts: 6,781
Loc: Under your bed.
Last seen: 2 years, 5 months
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: Bitter Cactus]
#21776358 - 06/07/15 10:12 PM (8 years, 7 months ago) |
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I heard about this earlier, I wonder how it's going to work. This brings to mind Brave New World, in the book the government and society highly promoted promiscuity and giving into your lusts. Is that where this society is heading? It certainly seem's like it.
-------------------- Utwiddle.net In order to act like a king, one need only treat everyone else like one. BUMP THIS THREAD EVERYTIME YOU SEE IT Join the Anarchy Camp! Down with Oppression!!
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Bitter Cactus
reformed bad boy


Registered: 01/26/12
Posts: 11,773
Loc: Alberta, Canada
Last seen: 8 years, 4 months
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: TheMovement]
#21776368 - 06/07/15 10:13 PM (8 years, 7 months ago) |
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Sorry I posted a shitty article but this is what it does:
Their enhanced sex lives included better arousal, lubrication and orgasm.
"In terms of ability to achieve orgasm, there was a statistically significant movement," Laura Berman said on ABCNEWS' Good Morning America.
"It increases blood flow to the genital area, increases the sensation of warmth, tingling and fullness," she said.
Edited by Bitter Cactus (06/07/15 10:14 PM)
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TheMovement
faeirie princess in training



Registered: 07/30/12
Posts: 6,781
Loc: Under your bed.
Last seen: 2 years, 5 months
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: Bitter Cactus]
#21776374 - 06/07/15 10:14 PM (8 years, 7 months ago) |
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Quote:
Bitter Cactus said: Sorry I posted a shitty article but this is what it does:
Their enhanced sex lives included better arousal, lubrication and orgasm.
Here baby, take a horny pill
-------------------- Utwiddle.net In order to act like a king, one need only treat everyone else like one. BUMP THIS THREAD EVERYTIME YOU SEE IT Join the Anarchy Camp! Down with Oppression!!
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trippinballs420
Samall Johnson



Registered: 09/17/12
Posts: 11,903
Loc: CO
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: Bitter Cactus] 1
#21776379 - 06/07/15 10:15 PM (8 years, 7 months ago) |
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so many more drinks are gonna get spiked
-------------------- ModestMouse said: "Much love for all of the regs here that's all I got to say
"
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VivaLaMushie
RIP LS :(


Registered: 07/23/12
Posts: 15,711
Loc: Switzerland
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: Bitter Cactus]
#21776382 - 06/07/15 10:16 PM (8 years, 7 months ago) |
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I wouldn't need to take this. Maybe when I'm older, but now I'm fine.
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propensity
۞̷ ̶۞̷ ̶



Registered: 01/06/10
Posts: 11,056
Loc: Bedrock America
Last seen: 3 years, 6 months
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: trippinballs420]
#21776396 - 06/07/15 10:19 PM (8 years, 7 months ago) |
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"One practitioner said that when her patients asked her for help, “This is all I can tell them.” And then she stood in front of the microphone in silence for several uncomfortable minutes."
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۞̷̛̗̗͉͇̰̅͒ͯͩ̆ͯ̑͘ ̶̖̭ͧ͛ͬ͑ͣͦ̍ͧ͐͟͢ www.cactophage.com ۞̷̛̗̗͉͇̰̅͒ͯͩ̆ͯ̑͘ ̶̖̭ͧ͛ͬ͑ͣͦ̍ͧ͐͟͢ ̸ۨ͜۞̷̛̗̗͉͇̰̅͒ͯͩ̆ͯ̑͘ ̶̖̭ͧ͛ͬ͑ͣͦ̍ͧ͐͟Dolphins of Dank۞̷̛̗̗͉͇̰̅͒ͯͩ̆
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larry.fisherman
shoulda died already



Registered: 11/03/12
Posts: 36,294
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: Bitter Cactus]
#21776456 - 06/07/15 10:35 PM (8 years, 7 months ago) |
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Quote:
Bitter Cactus said:
Quote:
XLCaps said: Cocaine works too.
Ya but dude imagine the potential of this. Sluts will be slutting so much harder.
I can imagine night clubs introducing it in some kind of fine mist in to the atmosphere.
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rackem



Registered: 11/27/09
Posts: 14,024
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: larry.fisherman]
#21776467 - 06/07/15 10:39 PM (8 years, 7 months ago) |
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heres to hoping this comes out otc
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Detached
You know where...


Registered: 02/27/15
Posts: 2,942
Last seen: 10 months, 15 days
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: rackem]
#21776499 - 06/07/15 10:45 PM (8 years, 7 months ago) |
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I really don't understand why it took so long for a drug like this to become available on the market. There are something like over 25 FDA-approved drugs for male enhancement with a list of side effects that seem quite worse than the ones listed in the article above.
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rackem



Registered: 11/27/09
Posts: 14,024
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: Detached]
#21776544 - 06/07/15 10:55 PM (8 years, 7 months ago) |
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womens female viagra has been around much much longer than viagra... its called MONEY
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ModestMouse
IM WALKIN ON SUNSHINE


Registered: 05/06/13
Posts: 19,227
Loc: Upstate
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Re: FDA panel recommends approval of ‘female Viagra’ [Re: jboredone]
#21776595 - 06/07/15 11:08 PM (8 years, 7 months ago) |
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Quote:
jboredone said: was gonna say mdma....
-------------------- Anyone got a lowpass filter in this biiiiash?
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