Category Archives: Female Viagra

Following in the footsteps of Viagra, female libido booster Addyi shows up in supplements

By Megan Thielking

Following in the footsteps of its predecessor Viagra, the female libido drug Addyi has snuck into over-the-counter supplements that tout their ability to “naturally” enhance sexual desire.

The Food and Drug Administration announced a recall Wednesday of two supplements marketed to boost women’s sex drive. The supplements Zrect and LabidaMAX — both manufactured by Organic Herbal Supply — actually contained flibanserin, a medication approved by the FDA in late 2015 to treat hypoactive sexual desire disorder in women. It’s the first time federal officials have recalled a product contaminated with the drug.

“It’s the latest example of brand-new drugs being found in supplements,” said Dr. Pieter Cohen, a physician at Harvard Medical School who studies dietary supplements.

The problem has long plagued the male sexual enhancement supplement market. Viagra has turned up in dozens of over-the-counter pills that never declared they contained the drug. The FDA regularly checks supplements shipments for the presence of Viagra, and has added flibanserin into their scans since the drug was approved.

“FDA lab tests have found that hundreds of these products contain undisclosed drug ingredients,” said Lyndsay Meyer, a spokesperson for the agency.

The massive dietary supplement industry is largely unregulated. The products can be sold without a prescription in supermarkets, supplement stores, and, increasingly, online. The products currently being recalled were sold on Amazon through February.

And while supplement makers are not allowed to claim that their products cure or treat a particular condition, they are allowed to make general claims that their products support health or, in this case, promote sexual desire.

“There’s nothing that you can actually put into the pill that lives up to advertised claims, so there is this temptation to introduce a pharmaceutical drug that attempts to meet those claims,” said Cohen. Organic Herbal Supply, which is recalling its products, did not respond to a request for comment.

The FDA said it has not received any reports of adverse events tied to either of the supplements. But Cohen said they are far from safe — and argued a lack of regulation will allow those risks to remain.

“We have no idea the harms being caused by these products. As long as these products can be sold as if they improve your sexual health, there’s going to be no stopping this,” he said.

The amount of undeclared flibanserin in a supplement could vary widely from one pill to the next, as has been the case with Viagra. It’s also possible the drug could be introduced into a supplement along with other potentially libido-boosting compounds, exacerbating those effects.

“We don’t know what danger this poses because these combinations have never been studied before they’re sold to unsuspecting consumers,” Meyer said. Consumers can report adverse events tied to these or other dietary supplements to the agency online.

Cohen said the message from the recall is clear: “Consumers should just completely avoid sexual enhancement supplements. They either might be safe and don’t work, or they might work but are likely to be dangerous.”

Complete Article HERE!

Female Sexual Dysfunction, Another Perspective

Hey sex fans,

It appears that my posting of last week, Female Sexual Dysfunction Is A Fictional Disorder, caused quite a stir.  As you recall, I was answering a question from a woman who asked if FSD, or female sexual dysfunction is real or a fictitious “ailment” that is being promulgated to sell pharmaceuticals to unsuspecting women.  I replied; “I think that, for the most part, female sexual dysfunction, or FSD, is a fictional disorder. I also think pharmaceutical companies are trying to hit on a female version of Viagra to treat this imaginary disorder so they can make a bundle, just like they did with as the male version.”

Well, that didn’t sit well with some friends and colleagues. One among them, Dr. Serena McKenzie took the most exception. She sent me a little note: “Your blog on female sexual dysfunction being fictitious is – respectfully – fucking bullshit sir.” Ok then!

I invited Serena to make her case not only to me, but to all my readers. What follows is Serena in her own words.

Flibanserin, the first and only medication available for use in reproductive aged women with low libido, becomes commercially available this week after a rocky and controversial road that led to its FDA approval Aug. 18. The view on the medication whose brand name is Addyi (pronounced ADD-EE) ranges from a historical achievement in women’s health care to an epic failure of commercialized medical propaganda. Despite the lengthy debate that has surrounded flibanserin, what most people want to know is whether it will help their sex life or not now that it is here.

addyi


First Things First

While sexual concerns can be difficult to discuss for many women and their partners, it is important to acknowledge that sex and intimacy are some of the great extraordinary experiences of being human. When sex goes badly, which statistically it does for 43 percent of U.S. women, the consequences can devastate a relationship and personal health. One of the biggest applauds I have for the FDA is their statement of recognition that female sexual dysfunction is an unmet clinical need.

Sexuality Is Mind-Body But Not-Body?

Sexuality is usually complicated, and problems with sex such as loss of libido are multifactorial for most women. Antagonists to flibanserin cite psychosocial contributions such as relationship discord, body image, or history of sexual abuse to be the most pinnacle causes of a woman who may complain of problematic lack of sexual desire, and that sex is always a mind-body phenomenon. While these factors often implicitly correlate to loss of sexual interest for a woman, they don’t always, and you cannot advocate that women’s sexuality is all inclusive of her mind, body, and spirit — and assert simultaneously that a biochemical contribution which flibanserin is designed to address in the brain to improve satisfying sexual experiences does not exist.

(c) Myles Murphy; Supplied by The Public Catalogue Foundation

(c) Myles Murphy; Supplied by The Public Catalogue Foundation

The Biochemistry of Sex

Antidepressant medications that alter brain biochemistry are notorious for having sexual side effects which can be prevalent up to 92 percent of the time, and are known to decrease sexual interest, disrupt arousal, and truncate orgasm in some women. Ironically, flibanserin was originally studied as an antidepressant, and while the exact mechanism of how a medication can impair or improve sexual interest is unknown, it should not be difficult to consider that if biochemical tinkering can crush sexual function, it may also be capable of improving it.

Efficacy Data Dance

Flibanserin is a pill taken once nightly, and has been critiqued as showing only modest increases in sexual desire, with improvements in sexually satisfying events rising 0.4 to 1 per month compared with placebo. However just because flibanserin has lackluster efficacy data, that does not mean it is ineffective, and even small improvements in sexual function can be life altering for a woman struggling with disabling intimate problems. If only 1 percent of women with low libido were to improve their sexual function with use of flibanserin, that equates to 160,000 women, or the population of Tempe, Arizona.

Blue Sky Side Effects

Flibanserin has side effects, and the sky is blue. All medications have pro and con profiles, and for flibanserin the most common consequences of use include fatigue, dizziness, sleepiness, and a rare but precipitous drop in blood pressure. Women may not drink alcohol while taking this medication. Providers who will prescribe it and pharmacies that will dispense flibanserin must be approved through what is called a Risk Evaluation and Management Strategy, or REMS, which means they are educated on advising women on how to take flibanserin safely. While a REMS program is arguably overkill compared to numerous higher risk, common prescriptions which do not require a REMS, it is an excellent opportunity for clinicians who have a background in sexuality to be the main applicants since they are far more qualified to assess proper candidates for treatment as well as continue to endorse holistic measures alongside flibanserin. Women who are interested in trying flibanserin should only obtain it from sexuality trained professionals.

The Proof Is In The Sexy Pudding

If flibanserin is worthless, the marketplace will bury it in a shallow grave quickly. Women will stop paying for it, and conscientious medical providers will stop prescribing it. Yet 8,500 women taking flibanserin were studied, over a 1,000 of them for one year, and the data suggests it will help some. Women deserve to be educated on their options, because sexual health is worth fighting for.

Changing The World, One Orgasm At A Time

We simply cannot overlook how astronomical of an achievement it is to even have a mediocre medication approved for female sexual dysfunction. Women’s sexuality has been ignored by medicine for most of history. At least now we have something to fight over.

The controversy about flibanserin is in fact magnificent, and frankly, the entire point. We must talk openly about sexuality and sexual concerns to improve them, personally for one woman at a time, but also uniformly to embrace female sexuality as a vastly larger societal allowance.

A satisfying sexual life is far more than the restoration of sexual dysfunction, it’s a thriving, multi dimensional, ever evolving weave of psychology, relationships, life circumstances, and yes can include a milieu of biochemistry and neurotransmitter pools.

Is a pill ever going to replace the vastly complicated arenas that fuse into our sexual experience? Of course not — it’s absurd and lazy-minded for anyone to suggest that is even being proposed. But it is necessary and inherently responsible to allow for all possible puzzle pieces to be utilized through the ever evolving navigation of sensuality, intimacy, and erotic fulfillment.

So will flibanserin make your sex life better? Maybe. But considering the conversation about it valuable as well as its use as merely one tool among many options to improve sex and intimacy would be the better bet. Ultimately, we “desire” sex that is meaningful, erotic, and dynamic. The journey of seeking sexual vitality deserves every key, crowbar, heathen kick, graceful acrobatics, or little pink pill that lends its part to the process, no matter how small or big, for the opportunity to discover and embrace a sexual aliveness.

Holistic physician, certified sexual medicine specialist, sex counselor, medical director of the Northwest Institute for Healthy Sexuality

Female Sexual Dysfunction Is A Fictional Disorder

Name: Sharon
Gender: female
Age: 30
Location: PA
I’ve been reading a lot lately about FSD, or female sexual dysfunction. Is there such at thing? It strikes me as a fictitious “ailment” that is being promulgated to sell pharmaceuticals to unsuspecting women. What are your thoughts?

I share your skepticism. I think that, for the most part, female sexual dysfunction, or FSD, is a fictional disorder. I also think pharmaceutical companies are trying to hit on a female version of Viagra to treat this imaginary disorder so they can make a bundle, just like they did with as the male version.

body as art

So much of female sexuality is caught up with the cultural context of a women’s role in society — family obligations, body image and patriarchal views of marriage, etc. For the most part, men aren’t nearly so encumbered. So when one talks about female sexuality, particularly when the notion of a condition or a disorder arises; ya gotta ask yourself, what’s going on here?

I too have been noticing a lot of discussion in the popular culture lately about female sexual dysfunction. My first response is to ask myself, who’s raising the issue and why? Sure some women, like some men, experience difficulties in terms of desire, arousal and orgasm, but what of it? Is it a syndrome? Is it really a dysfunction? I personally don’t think so. The sexual difficulties most people experience can be explained and dealt with in a less dramatic way then with drugs?

And here’s an interesting phenomenon; the repeated appearance of the term female sexual dysfunction in the media lately actually gives the concept legitimacy. I’m certain the pharmaceutical industry is hoping that it will. If they can make the connection in the public mind between what women experience in terms of desire, arousal and orgasm concerns and what men describe as erectile dysfunction, then most of the work is done. In other words, I think the entire effort is a marketing ploy.

female sxualityI think we can safely say that, in order to determine what female sexual dysfunction might be, one has to clearly understand what a “normal” sexual response is for a woman. This is where we traditionally run into problems. Sex science is notoriously lacking in this endeavor. One thing for certain, although both women and men have a discernable sexual response cycle, a woman’s sexual response is not the same as a man’s. Even though we can’t say with certainty what “normal” is, therapists are famous for turning difficulties into disorders. And once you have a disorder it becomes the basis for developing a drug therapy. So you can see how this becomes a self-fulfilling prophecy.

Currently there’s a real buzz among clinicians concerning the efficacy of Addyi, the so-called “female Viagra”. But most sexologists, myself included, are unimpressed. Basically, the drug in question is an antidepressant. When I heard that, red flags began to fly. Antidepressants are notorious for their adverse side effects, especially in terms of sexual arousal in both men and women. The second problem with the study was the whole notion of desire and distress. Lots of women experience diminished sexual arousal but are not distressed by it. But if there’s no distress, clinically speaking, then it can’t be considered a disorder. You see where I’m going with this, right? If there’s not a “disorder” there’s no need for a pharmaceutical intervention.FUCK

According to the research some of the women in the clinical studies leading up to the approval of the drug claimed they were less distressed by their “condition,” Hypoactive Sexual Desire Disorder, than they were at the beginning of the study. According to clinical trials of Addyi held in 2013, only 8% – 13% of the women experienced “much improved” sexual desire and only about 2 more satisfying sexual encounters per month were had. In other words, when behaviors were studied, the actual number of satisfying sexual episodes reported by these less distressed women hardly changed of all. This indicates to me that the antidepressant helped lift the spirits of the distressed women, but did nothing to increase their satisfaction with their sexual outlet.

Twice the FDA rejected Addyi for its severe side effects and marginal ability to produce the effect that it is being marketed for. And despite the fact that the drug is now available, those side effects still exist. Women who take the pill are likely to experience dizziness, nausea, drowsiness, fainting spells, and falling blood pressure. Coupled with alcohol and even hormonal contraceptives the odds of these potential side effects occurring increase. Persons with liver ailments, or taking certain other medicines, such as types of steroids are also at higher risk. On the other hand Viagra has very mild side effects that may include headaches, indigestion, blue-tinted vision and in some cases a stuffy nose.

While a man can pop Viagra an hour or so before he plans to have sex, women who are looking for increased sexual desire need to take Addyi daily for up to a month before they should expect to see any effects.

Good luck