The Facts About Addyi, its Side Effects and Women’s Sex Drive

addyi prescription
Addyi / Sprout Pharmaceuticals
By Diana Zuckerman |

by Diana Zuckerman, National Center for Health Research
& Judy Norsigian, Our Bodies Ourselves

It’s been almost impossible to ignore the media fascination with “pink Viagra” and the public debate about whether the drug flibanserin — soon to go sale as Addyi — should have been approved last month by the Food and Drug Administration.

The debate was strongest among feminists, who were divided between those who agreed with the FDA scientists who deemed the drug not effective and possibly unsafe, and those who joined the Even the Score campaign, accusing the FDA of sexism for rejecting the drug twice before. The campaign was organized and funded by Sprout Pharmaceuticals, maker of flibanserin.

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It wasn’t always comfortable speaking against FDA approval — and against the claims of our friends at NOW, National Council of Women’s Organizations, National Consumer League, and elsewhere. But we scrutinized the evidence and found it very weak, as did the National Women’s Health Network and Jacobs Institute of Women’s Health, among others.

Here are the facts.

The FDA has approved numerous drugs for men’s erectile dysfunction and for women’s vaginal dryness. Both are physiological problems that greatly reduce sexual enjoyment. What the FDA has never approved — before Addyi, that is — is a drug that increases men’s or women’s libido.

Very few men complain about lack of libido, but 10 percent of pre-menopausal women do. That’s a lot of women, and drug companies have been trying to find a solution, knowing it would be a lucrative one. (One physician in particular, Dr. Irwin Goldstein, whose ties to pharmaceutical companies were recently chronicled by Mother Jones, has been eager to help.)

So one part of the debate centered around women’s lack of libido, a complicated issue. When women define it as a problem, are the origins physiological, psychological, sociological, or some combination of all three? And were pharmaceutical companies turning a temporary problem related to specific circumstances into a medical problem (what many experts call “disease mongering”)?

As we all know, there are many possible reasons for lack of libido. The quality of a relationship — and the quality of a sexual relationship — are key factors. We also know that some women who experience reduced spontaneous desire for their partners have no trouble experiencing desire once they become aroused by physical contact or another form of intimacy. For them, the desire is simply responsive, rather than spontaneous.

Exhaustion from childrearing, household tasks and work are also important factors. Some of us find that the emotion and energy we put into childrearing, not just the number of hours, tends to deplete sexual passion.

During the FDA debate, a key unanswerable question was whether low desire is a physiological problem that sometimes has nothing to do with women’s relationships or life circumstances. However, some doctors suggested that regardless of the cause, medication could help.

Let’s look at the data on Addyi to see what it tells us. Studies yielded two important results. First, the drug had a positive impact on women’s sexually satisfying experiences — but so did the placebo, the sugar pill with no active ingredient. In fact, based on daily diaries that the women were required to keep online, the drug added nothing or very little to the very robust “placebo effect.”

So Sprout Pharmaceuticals did something that many of us questioned. It convinced the FDA that it made more sense to ask about sexually satisfying experiences once a month, instead of daily, to measure the impact of the drug. Once that change was made, the pill was slightly better than the placebo: Users registered somewhere between 0.5 and 1.0 more sexually satisfying experiences per month.

But in addition to questioning how accurately anyone can remember the previous month’s sexual moods, medically that benefit is minimal, at best. So what about the risk?

Unlike drugs that men take to increase blood flow to the penis when they cannot have or maintain erections, Addyi is more similar to an antidepressant in that it acts upon chemicals in the brain and needs to be taken every day for as long as you want it to work. Women are warned not to drink alcohol — at all — or use numerous other prescription medications because the interaction is potentially dangerous.

Exactly how dangerous is unclear, because the drug maker tested what happens when you mix Addyi and alcohol on 23 men and two women. That’s right: two women.

“Once again we are through the looking glass,” said Dr. Carolyn M. Mazure, director of Women’s Health Research at Yale. “Prescribing medical treatments for women without fully exploring the possible differences between how that treatment might react in women as opposed to men.”

Based on safety data submitted to the FDA, we know that four of 23 subjects who took Addyi with the equivalent of two glasses of wine, consumed quickly, had events of severe hypotension or syncope — a temporary loss of consciousness caused by a drop in blood pressure. Let’s hope women taking Addyi don’t pass out while driving or walking across the street.

The FDA is trying to protect women from danger by making Addyi available by prescription only through certified health care professionals (doctors who have been trained via a 15-minute online course) and certified pharmacies. And, the filled prescription will come with a black box warning — the FDA’s strongest warning language — about the risk of fainting or dangerous drops in blood pressure in patients who drink alcohol or use certain other drugs.

The FDA is also requiring the company to conduct three post-marketing studies to better understand the serious risks from interactions between the drug and alcohol for women. But if the company didn’t do such a study to get approval, what is the chance of doing it anytime soon?

Sprout, the pharmaceutical company that claims to care deeply about women’s health, was sold for $1 billion just one day after the FDA approved Addyi. We wish that the feminists who worked so hard to make that happen would receive a generous bonus to use on a wide-range of feminist issues, but we’re not optimistic.

The bottom line: We want the FDA to base approval decisions on scientific evidence. After the FDA twice rejected flibanserin, the drug maker developed a slick marketing campaign that underscored the importance of women’s choices and paid nonprofit organizations and health experts to actively oppose the FDA decision — something that most would not have had the time and resources to do otherwise.

While many of those supporters clearly believe in Addyi, some lack the scientific expertise needed to make sound judgments about the drug’s safety or effectiveness.

We believe that the FDA caved in to a marketing campaign in a way that sets a disturbing precedent. Women deserve safe and effective medical treatment, but there is every reason to believe that Addyi is not safe or effective for many of the women who will be taking it.

Diana Zuckerman is president of the National Center for Health ResearchJudy Norsigian is co-founder and past executive director of Our Bodies Ourselves.

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15 Comments

  1. Addy Jeffrey says:

    I was profoundly disappointed to learn that Sprout decided to trademark a woman’s name for this drug. Even the Score and Sprout do not care about gender equality. Girls and women named Addy (regardless of spelling) will be harassed as soon as the marketing campaign begins. Trademarking any woman’s name for a libido drug is an attack on ALL women.

  2. CAO says:

    My new book THE PINK PILL & FEMALE SEXUAL AROUSAL details the history and the irrefutable data manipulation behind the blind approval of Flibanserin by the FDA and not just the safety and efficacy issues. What happened in week 24? Why were only 8% of those tested for the Flibanserin-Alcohol interaction women and 92% men when the drug is meant for women?
    The drug demonstrated its lack of effectiveness, is not much better than placebo and the data manipulation steps have been carefully outlined. Unbelievable that the FDA would let this slip by!

    • CAO says:

      Still don’t understand why Valeant purchased Addyi and which of their own in-house specialists reviewed the available new drug application (NDA) data.

  3. Jennie says:

    I wouldn’t touch this product or any like it with a 100ft barge pole, let alone a 10ft one!

    More so in the States but increasingly now in the UK I see people reaching out blindly for some kind of wonder pill or similar to cure them of their ills or shortcomings without seeking out the tried and tested natural steps that can be taken.

    As a qualified nutrionist with decades of experience the first things I recommend to people with a sense of depleted libido is to get the basics right. It may seem a minor thing however it’s any thing but, get adequate sleep! This will day by day raise your mood and improve your sense of well being/confidence helping make you feel more attractive.

    Your second step should be made in the kitchen, again it seems like a simple, obvious step but the simple obvious steps are the ones people bypass the most easily, never achieving the full benefit of said steps. Eat well and it will raise your mood further, plus the physical improvements made will further make you feel sexier.

    To go even further I recommend supplementing with nutrients proven to aid circulation which will in turn stimulate those errogenous zones and give you more pleasure. Garlic supplements are a great place to start. You can obviously get this just as easily naturally in your diet but eating a bulb of Garlic a day is going to make you…er, shall we say, pungent. Odourless extracts are the way to go. Also Ginger should be high up on your list of supplements too. There are many more out there, just do a little research and see what works for you. If by then you’re still feeling that you’re lacking libido then at least when you feel you have to make the leap to medication, you’ll have a better functioning body which in turn should enhance the benefit (if any) from the ‘recommended’ pills.

    It may seem ‘face slappingly simple’ to many but it’s all in the implementation. I hope this helps 🙂

  4. Caxton says:

    Addyi doesn’t work. I was initially concerned about the side effects and decided to review the FDA documentation regarding the drug.
    The actual data was cut and paste and no ne noticed. The claim that it increases SSEs by 1 additional event a month is based on a placebo effect of zero and subtracting zero from 1 in study 511.71. This is one of the two studies( 511.75 is the other one) that Boehringer initially informed the FDA in 2009 that no statistical significance was shown compared to placebo. I was able to simplify all the data so it is not intimidating but it is shameful that such data manipulation would go into getting approval. You’ll be asking the question who really fell asleep and who was guilty of manipulation and who turned a blind eye when you see all the simplified data. Even a high school math student with no knowledge of statistics can figure the duplication and errors where data for desire was cut and paste for Sexual distress. Amazing. Keep up your good work of informing.

  5. Diane stevens says:

    How long does it take after taking oNE pill will I feel the desire..I could not afford prescription so just bought one

    • To have any benefit at all, Addyi must be taken every day for months. One pill will have no benefit. Your doctor should have explained that before writing the prescription and your pharmacist should have explained that before filling the prescription for one pill. You probably should find a new doctor who does a better job of explaining how to take medical products, because it is a waste of money and can be dangerous to take any medication differently from the directions.

      Even if taken correctly (every day) Addyi doesn’t work for most women, and as soon as a woman stops taking it, it stops working.

      Also keep in mind that Addyi is not approved for women who are going through menopause or have already gone through menopause.

      • Donna says:

        That’s the truth, I have taken the pill 6 weeks and nothing happening here!! I mean NOTHING

  6. DeAnna says:

    Night and day (1) on Addyi- I took it at bed time but didn’t go to bed right away and it made me nauseous. When I got up the next morning I was nauseous and dizziness.
    I’m having to stay laying down and take Finnegan.
    I will keep you up dated.

    • DeAnna says:

      The cost for Addyi with out Insurance at Walgreens is $965.99. I have Aetna insurance and it isn’t covered by them. I’m appealing it to be revue for coverage. I called my gynecologist which Prescribed it to me, I told them it wasn’t covered by my insurance and they sent me a coupons and it costed me $50.00 with it.

  7. Good and informative article. I take Addyi I hope it will work the mail supplier and my Doctor seem to be having a problem I keeping running out so I so not know if it works i realize I have some of issues
    that is does mot help but I need an mircle
    I feel like a non-sexual person. I have got to h;
    to have some help I want the sexy love
    feelings the I used to have when we were
    first married. My husband is being short
    changed I could forever and never have
    sex and he is sexual it is not right that there
    is no help for women of any age and any
    problem not to have help.
    I drink with Addyi and have none of the side
    effects that were mentioned. My main
    concern is that the drinking does not enter
    fear with Addyis performance. I have looked
    and looked and have found not any
    information discussing this issue.

    ;Your article was very great.

    • Thank you for your comments about our blog on Addyi. I’m glad you found it useful.

      I am so sorry to hear about your current loss of sexual desire.

      I am very concerned about 2 things that you said in your email:

      1. You said you are drinking alcohol but that you haven’t had any problems with the interaction between Addyi and alcohol. What I need to tell you is that you might not have any problems at first, but then suddenly you could have a terrible reaction that could be deadly. PLEASE do not take Addyi if you plan to drink any alcohol, and if taking Addyi is important to you, please DO NOT DRINK ALCOHOL.

      2. You said you’ve had problems getting your prescription filled regularly for Addyi. Addyi only works if you take it every day. It won’t work if you don’t, so it is a waste of money and a waste of your effort if you aren’t getting a prescription that you can take exactly as directed.

      But, as I said in #1, you should not drink alcohol while taking Addyi. Maybe you didn’t have trouble with drinking with Addyi because you weren’t taking Addyi every day. But that isn’t a solution, because you are clear that you want and hope Addyi will work and you need to take it daily AND NOT DRINK ALCOHOL to see if it works.

      There are other solutions to low sexual drive that I hope you can consider. Are you getting enough sleep (at least 7 hours a night, preferably more)? That will have a big impact on your sexual feelings.

      Are you eating healthy foods and getting some exercise? You don’t have to eat ONLY healthy foods but you should be sure that you’re getting some fresh fruits and vegetables every day, and try to ear fewer junk foods. That can also be very helpful.

      Are you taking any other medication that might be making you feel tired or depressed or not interested in sex?

      Are you under stress at work or with family responsibilities or other problems? For many women, stress has a tremendous “chilling effect” on feeling loving and sexy. Most new mothers for example, lose their sex drive for quite a while, and the demands of children and the loss of privacy can make that a problem for many years — long after babies are growing up.

      I’m not a doctor so I am not providing medical advice, but for many women, the day to day stresses and even just working hard, combined with being in a relationship for a long time, makes it difficult to feel as excited as they used to — or excited at all! But you might find that there are a few things you can do to help improve your chances of regaining those feelings, such as getting more sleep and the other things I mentioned above. So if you want to be able to relax with an alcoholic drink and Addyi doesn’t seem to be helping, you may want to stop taking it and try to make some other changes, like the ones I mentioned. And for most women in your situation seeing a counselor by yourself or with your husband, or a sex therapist with your husband, can be very helpful.

      • Nura says:

        10 percent of people have this problem. It’s a lot. The problem of dry vagina and decreased libido appears after long-term use of birth control pills. If medication will help to solve it that would be wonderful.