FDA panel backs female libido pill, under safety conditions

[Omaha Steve]

Source: AP-Excite

By MATTHEW PERRONE

WASHINGTON (AP) — The drug industry's decade-spanning search for a female equivalent to Viagra took a major step forward Thursday, as government experts recommended approval for a pill to boost sexual desire in women.

The first-of-a-kind endorsement came with safety reservations, however, due to drug side effects including fatigue, low blood pressure and fainting.

The panel of Food and Drug Administration advisers voted 18-6 in favor of Sprout Pharmaceutical's daily pill, flibanserin, on the condition that the company develops a plan to manage its risks.

The recommendation is a major victory for a drug sometimes hailed as "female Viagra," but which has been plagued for years by concerns of lackluster effectiveness and safety issues. The FDA has rejected the drug twice since 2010. And a similar panel of FDA experts voted unanimously against the drug five years ago.

FULL story at link.



FILE - In this Friday, Sept. 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. Government health experts on Thursday, June 4, 2015 backed the approval of the experimental drug intended to boost the female sex drive, but stress that it should carry safety restrictions to manage side effects including fatigue, low blood pressure and fainting. (AP Photo/Allen G. Breed, File)

Read more: http://apnews.excite.com/article/20150604/us--female_sex_pill-fda-86a4663c25.html

[kentauros]

1. "side effects including fatigue, low blood pressure and fainting."

Since when did such relatively "mild" side effects (when compared to the slew of side-effects stated in your average pharmaceutical commercial up to and including death) ever stop a pharmaceutical company in the past from getting their product approved and marketed? I get incredibly horrible fatigue effects from Allegra, yet my reaction is also in a low enough percentage to allow it to be marketed anyway.

The FDA's "concern" of the possible side effects seems "inflated" and insincere.

[enlightenment]

2. Given that there was testimony

to the effect of: "do women have souls", I'm not surprised that any drug that may cause a woman to get an extra tingle in her lady parts is seen as a problem by some . . .

[Psephos]

4. the government should stay out of people's bodies

FDA should provide an advisory function, and ensure that those considering a pharmaceutical substance have access to understandable, neutral, and factual information. All medications have side effects. Those that are acceptable to some are not to others...as with everything else.

[kentauros]

6. I'm not sure if you're being facetious or not,

but I think my point is valid and has nothing to do with the government staying out of our bodies. It has to do with how some drugs that have far worse side-effects appear to get almost rubber-stamped approval compared to the reaction with this one.

For example, I don't recall any outcry over side-effects for Viagra when it was being reviewed for approval, nor the same for any of the other drugs that have far worse side-effects (such as those that have the possibility of killing you; how's that for curing your ills?)

While I can understand the objections to this drug over its effectiveness being questionable, the hue and cry over its still "relatively mild" side-effects sounds like a different agenda than simply looking out for the public good.

[Psephos]

7. not facetious

I am the sole owner of my body. I am the sole decider of what goes into it and what stays out. I appreciate good information to make informed decisions. Providing such information seems a natural function of good government. Unfortunately, we don't have good government. Government looks out for the public good only after it looks out for its own interests, if at all, and those interests are intertwined deeply with those of the .01%.

The real issue here is not whether other meds with more serious side effects get approved. It's more about the ratio of benefit and risk. I do not trust other people with different interests than my own to tell me what's acceptable. Granting such authority to others is validation of a master/slave relationship.

I am continually shocked at both the naivete and the readiness to submit to authority among so many here and on the left side of the spectrum. There is no more liberal concept than the principle that freedom to live autonomously is a birthright.

[kentauros]

8. Okay, thanks for the explanation.

And I feel you're right about who the FDA truly serves. In this case, they seemed to be reacting more with shock that some women (those that would take this drug) might want a little help with sex.

[Psephos]

9. you seem like someone who values civil discussion, as do I

I look forward to more of same.

I omitted in my last post to say that your point was sensible and worth thinking about.

[kentauros]

10. Thanks, as do you.

I know I've probably agreed with you in the past, yet can't recall those instances now. So many names here...

[aceofblades]

14. An interesteing argument but does it have limits in your view?

As it seems you are making a philosophical, perhaps classically liberal point of view among others, perhaps I could ask a hypothetical question based on what may be a logical extension of your statement. "government should stay out of peoples bodies"

What if a private citizen(lets say your neighbor) wanted to purchase another product that could be ingested into their bodies theoretically, but not a medication, lets say anthrax from a laboratory. Do you believe that a government has a vested interest in stopping that from happening? Would you support a government who decided to stop such a transaction from taking place? would your answer change if your neighbor wanted to purchase ebola virus?

To take the question a step further (again just curious as to the extent of your beliefs& if it is in the context of a larger one)Do you believe government has a moral right to stop any transaction from taking place at all? Say purchase of nuclear weaponry between a private citizen & other interested parties(lets say a corporation or private military contractor that was rich enough). Governments are of course corrupt in this matter as well, but would you feel safer if the exchange and proliferation of nuclear weaponry could be done without coercion or impunity from anyone?

Now this may seem as a reducio ad absurdum, and it is, but I'm using it because I'm interested in hearing more about a statement that I feel is fairly broad & you seem to be receptive to such discussion

[One_Life_To_Give]

20. Perception of Benefit

IMO - When they do the Risk vs. Benefit calculation. They perceive little benefit so even a negligible risk is a big deal where-as with for example Cancer Treatment the Risk can be much higher as the Benefit is viewed as much higher.

Thus for those who think a woman should lie back and think of England. This pill serves no purpose and any risk is unacceptable.

[woodsprite]

22. We probably won't just be able to go to the doc and request a script for it either.

We'll probably have to be tested out the whazoo and get husbands to sign off on it or prove we had a significant other.

I'd sign up for a trial. Surgical menopause for me paused more than I needed (or wanted) it to.

[kentauros]

23. So sorry about what happened with your surgery

I won't ask what happened, but it sucks for giving you more than you bargained for.

As the other poster above suggested, you'll be asked if you have a soul, too

It all makes me wonder how many women were on that FDA panel. As a man, I'd never have to put up with the horror of being asked such a demeaning question. I mean, the side-effects are that I might never get an erection again!!1! But, I wouldn't have to wait long for FDA approval of the next level of Viagra-type pharmaceuticals...

[RufusTFirefly]

3. Whatever you post, no Spoonerisms or tongue twisters, please!! n/t

[joshcryer]

5. Sounds like ecstasy would be better.

[madokie]

11. or a caring, loving relationship

does wonders

[Android3.14]

12. Your misunderstanding could hurt some

There are too many women and men who are in loving relationships, but for which the sensual side of the duo has faded.

Your comment is much like blaming the victim, as these same people go to great lengths to rekindle that sexual spark, but only to have it fail again, and then suffer from guilt wondering if they could have done more.

[NickB79]

21. It specifically says this drug is not for treating women with relationship problems

If approved, flibanserin would be labeled for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress. Doctors must rule out a number of alternate causes before diagnosing the condition, including depression, relationship problems and mood disorders.

[PADemD]

13. How is drug-induced fatigue going to help someone's sex life?

Fatigue was probably the problem in the first place.

[Martak Sarno]

15. fainting vs over 4 hour erection problems?

I've asked a number of friends who use Viagra or Cialis if they are aware of the "cure" for an erection lasting more than 4 hours. None knew. Those who are concerned that fainting or low blood pressure might be a hindrance for a female pill will find googleing (or any of the medical sites) rather shocking to learn the consequences of a longer than 4 hour erection (which isn't described in the commercials so as to scare men away from contributing to Pharma).

And sadly, we are not the sole (or even soul) owners of our bodies. In addition to courts deciding whether treatment or voluntary cessation of one's life can be forced on a person, a ruling a number of years back gave possession of ALL of our DNA to a couple of Pharma Groups. You don't even have the right to the "stuff" you and you body were born with.

About time females enjoyed, if even limited, the sexual freedom granted men by men who feel they have the power and/or right to tell women what they can and can't do.

[TexasBushwhacker]

16. Interesting

It was originally being developed as antidepressant, but during clinical trials many of the women reported increased sexual desire. The article says it affects serotonin "and other brain chemicals". I wonder what the others are. It looks like it works for some women, but probably not most. The average increase is only 1 time per month and it's for premenopausal women only. Very interesting.

[bklyncowgirl]

17. Side effect...cardiac arrest...among sedentary middle aged men.

Meet George. George is fifty something, a bit overweight, talks a good sexual game with the guys but to be honest he and his wife Linda only get it on once or twice a month if that. Linda's always been cool with that or so George thought but now all of a sudden he comes home one day and there's Linda in this skimpy little teddy and a thong--a thong no less--with this weird smile on her face and a martini in her hand.

'Oh crap!' thinks George.

Seriously, how much of this is all about men's fear of women's sexuality?

Listen to those Viagra commercials always telling men that they have to be "ready". These speak to a very real fear that the Lindas in their lives may make, er, demands on them that they may not be able to meet.

Oh but the female pill has side effects. Well Viagra has side effects--serious ones but no one cares about that and talking about side effects, there's this commercial for Premarin cream, used to lubricate the lady parts so that Linda's once a mother with George won't hurt. The commercial has a list of side effects that would make anyone shudder--although I suppose if you're desperate enough to smear something made from horse piss all over your hoohah a few rashes and vaginitis and potential cancer won't stop you.

The point is that that Premarin is designed to allow the Linda's of the world to endure sex, that's ok. Something to help Linda enjoy sex and therefore make demands on George--that's a problem.

[Sunlei]

18. is this the same flibanserin that has been cheap over the counter Dietary Supplement for years?

[FLPanhandle]

19. I'm a middle aged man married for over 20 years

Not sure I want my wife wanting even more sex. I might have to get Viagra if that happens.

Then we would both be having drug triggered sex.