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The Lolas also talked about new anxieties, knowing how their “revived” husbands were now looking for new extra-curricular adventures. On top of all this, when reports of serious side effects from Viagra began to emerge, including deaths from heart attacks, the Lolas (and from a friend, a Lolo with a Lolo partner) began now to worry about their Viagra-powered partners’ kicking the bucket in some cheap motel. Now comes the little pink pills with the curious HSDD indication.

How do you take Addyi?

The drug comes close to being an antidepressant, which translates to possible side effects like sleepiness, dizziness and hypotension (low blood pressure). There are also concerns that drinking alcoholic beverages can increase the risks of those side effects. The women’s groups point out only one study has been made into possible alcohol interactions with the drug… and that the study involved 23 men and two women—yet another example of gender trouble in the world of pharmaceuticals. The bigger debates cluster around the issue of “a pill for every ill,” an old expression that can be modified as “a pill for every ill, made up or real.” In the first half of the 20th century, the world would rejoice whenever new drugs were discovered, mainly to fight infectious diseases. In the last two or three decades, we have seen the rise of “lifestyle drugs,” the best-selling ones being those for baldness and for erectile dysfunction.

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These conditions are not life-threatening, but there is a huge market for the drugs. Shortly after Viagra was approved in America, it was already being sold in the Philippines even without government approval. One venerable Filipino congressman was even caught trying to smuggle in a suitcase filled with the blue diamonds, much more than he would need in a lifetime. Questions were raised about relying on pills for sexuality problems. While the physical aspect of erectile dysfunction is very real, and associated with age, smoking and illnesses like diabetes, there is also a strong psychosocial component for which counseling is as important as the pills, including dealing with “performance anxiety”. Curious because the condition, which is considered a psychological disorder, was taken out of the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) released in 2013.

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HSDD is now incorporated into a syndrome called female sexual interest/arousal disorder.

Overdose/Missed Dose

.in a macho society like our’s, men are under incredible pressure to, how do we put it politely, keep going. I’ve been preparing to deliver a paper on sexuality and the elderly, which took me into journal articles about the erectile dysfunction drugs and I found almost nothing on the “relational” aspects of Viagra, i.e. what does it mean vardenafil vilitra 60 mg for a man’s partner when he uses Viagra? The most striking example of this relational aspect were reports from my physician friends about older Filipinas describing how relieved they were when their husbands began to “falter” with age because they were less demanding. Then Viagra came along and suddenly elderly wives had to rise to new and sometimes more demanding conjugal requests from the Lolos. We’ve gone a long way from the first edition of DSM just talking about impotence and frigidity, terms no longer in medical use.

Real Science. Real Results.

But those antidepressants, which raise levels of the neurotransmitter serotonin, are known to blunt libido. Addyi blocks certain cellular receptors from responding to serotonin. Women who took Addyi in a clinical study had an increase of about one sexually satisfying event per month compared with those taking a placebo. Critics say the small benefit is outweighed by the drug’s risks. Addyi will come with a prominent "boxed warning" about side effects, including among people with liver impairment or who take Addyi with alcohol or with medicines known as CYP3A4 inhibitors that include certain steroids.

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Originally developed by Germany's Boehringer Ingelheim under its chemical name flibanserin, it was first rejected by the FDA in 2010 after an advisory panel said the benefits did not outweigh the risks. Sprout acquired the drug, conducted additional studies and resubmitted the application. In 2013, the FDA rejected it again. The rejection sparked a lobbying campaign by Sprout, aided by some women's groups who accused the FDA of gender bias because it had approved Viagra for men - a charge the FDA vigorously rejected. The FDA approved Addyi despite a rocky relationship in recent years with the founders of Sprout.

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The chief executive of Sprout, Cindy Whitehead, co-founded the company with her husband Robert Whitehead in 2011 after selling another small drugmaker they had founded called Slate Pharmaceuticals which had received repeated warnings from the FDA about its marketing tactics. Slate marketed an implantable testosterone pellet for men with low levels of the male sexual hormone, called Testopel. In one FDA warning letter, issued on March 24, 2010, the FDA said Slate had improperly inferred on its Testopel website and in a video that the testosterone product could help patients with depression, erectile dysfunction, diabetes and HIV. The Whiteheads could not be reached for comment late on Tuesday about Addyi's approval and their earlier encounters with the FDA. Our Standards: The Thomson Reuters Trust Principles. I just might write about the alphabet soup of sexual disorder names in a future column. Whatever the name might be, the psychological aspect is again important, including the possibility that the condition should not even be considered a disorder or disease.

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Even more so in women than in men, there are many reasons for the inability to derive pleasure or even have sexual desire, including the partner. In fact, with women the problem may even be worse, involving not just a lack of pleasure but painful sex. We’re bound to see more debates in the western media about these new pills. What I’ll be monitoring are the developments in the Philippines.

Is Addyi effective?

In 1998 the approval of a new drug by the US Food and Drug Administration (FDA) made front-page headlines. The drug was Viagra (generic name: sildanefil), for use in erectile dysfunction. It soon acquired names based on its color and shape—“little blue pills,” “blue diamond.” In the ensuing years, Viagra had “cousins”—Cialis (tadalafil) and Levitra (vardenafil)—which provided friendly competition. Just this week another FDA decision again made world headlines: the approval of the drug Addyl (flibanserin). And the media are already talking about “little pink pills,” almost as if the drug were color-coded for its target group of patients: women with hypoactive sexual desire disorder or HSDD.

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All these drugs have triggered many discussions around social, cultural and even political issues, showing how medicines are more than just chemical substances. In Japan, for example, Viagra’s approval brought protests from women’s groups, who decried the high priority given to male erectile problems. The groups observed that it took six months for the government to approve Viagra and 34 years for a low-dose hormonal contraceptive (“the pill”). The market for these drugs has not just been men with erectile dysfunction, usually those who are middle-aged and elderly, but also young men. The drugs work by increasing blood flow to the penis, but young men claim other uses and buy the pills to enhance their “performance” or even to increase penis size.

How can I get more information about Addyi?

These claims, I should emphasize, are urban myths and have no scientific basis. On the surface, the approval of Addyl may look like a step toward gender equality. Its manufacturer, Sprout Pharmaceuticals, did in fact launch a campaign—dubbed “Even the Score”—for its approval, claiming that it would address the inequity of so many drugs for men’s sexual problems and none for women. Yet, criticism of the little pink pills has come mainly from women’s organizations, who warn that the drug poses many problems. Instead, it works mainly on the brain to get a balance of chemicals to produce more pleasurable feelings. I doubt if our female legislators or politicians are going to try to smuggle in the pills, but I suspect there will be a market for the drug here. I actually suspect there will be greater demand from Filipino males trying to get the medicines for their female partners. I worry that there will be unrealistic expectations, and the rise of sinister plans for using it without the woman knowing. If anything, I hope though the new pills will get Filipinos, men and women, to discuss women’s sexual desires and pleasure, a topic not usually in the realm of polite conversation but which is very much in the minds of people. To some extent, Filipino males do recognize, even fear, female desire; male overseas workers fret constantly about this when they are deployed abroad, more in terms of who is “satisfying” their wives. Which takes me to the clinical trial that got Addyl approved, involving 5,000 women with HSDD. Those taking Addyl said the number of “satisfying sexual events” during the research period went from 2.8 to 4.5.

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The problem is that the placebo group, meaning those who got a pill without any active ingredient, also reported on average an increase in these “satisfying” events, from 2.7 to 3.7.

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Instead of just worrying about satisfaction, instead of buying the little pink pills, we should be questioning the way we look at the conditions, and the quest for pharmaceuticals to “treat” them.

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Let’s talk more, look more into ways to enhance the aspects of a relationship—being considerate, caring, loving—that do much more for pleasure, satisfaction, even passion, than any pill can. Addyi helps balance neurotransmitters like dopamine, serotonin, and norepinephrine to support sexual desire. The exact way Addyi works is unknown. ADDYI was studied in four 6-month clinical trials in more than 3,200 women with low sexual desire, of whom 902 were postmenopausal and under 65.

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Participants were randomly assigned to receive ADDYI or a placebo.