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
“It can have significant side effects including nausea, dizziness and sleepiness.”
My wife doesn’t need to take a pill to get those symptoms.
LoL?
Neither do I.
OTOH, I am taking many pills of different kinds for many years now, so maybe that is why....
this may lead to an epidemic of world-wide nymphomania (a product of the brains pleasure center)
Why did you have to post that - I was eating. Eeeeww!
“It can have significant side effects including nausea, dizziness and sleepiness.”
I think most of us would rather fake it than take it. :-)
Well scientists discovered decades ago a substance which reduces the libido of women by over 95 percent.
Wedding cake.
How did Bill Cosby vote?
THAT JUST TOOK 6 OF MY 9 LIVES.
Only the misinformed men think that.
Good grief! Is that really Hillary? Where was this?
You’ve done enough. Have you no sense of decency, sir, at long last? Have you left no sense of decency?
She could ride that rear end around Churchill Downs!
Yup. South Africa.
Google Hillary Bump and Grins.
I would post it but I am on my phone right now.
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.......
That’s okay; seeing the clip you posted was scary enough.
“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.
“Exactly. Cant stop mens 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.
Not the women on this forum.
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