The People's Perspective on Medicine

The Inside Story on the Female Sex Pill Flibanserin (Addyi)

What's the straight and skinny on the new sex pill for women? Flibanserin (Addyi) has gotten a lot of headlines but what is the real story on pros and cons?

There has been a great deal of excitement about the FDA’s announcement that it has finally approved Addyi for women with low sex drive. Not surprisingly, this is the hot health story this week and the talking head “experts” have been all over the map commenting about the pros and cons of flibanserin to lift libido.

The Enthusiasts:

Some women’s groups and health experts have characterized flibanserin as a “breakthrough.” They describe the pink pill as an enormous advance in women’s health, “evening the score” when it comes to sexual equality. They point out that there are dozens of drugs for men to enhance erections and now, at long last, there is something for women that will improve their sex lives.

The brand name Addyi, which is pronounced ADD-ee, seems weird to us. Most people will likely call it AD-YEE. However it’s pronounced, the drug has stirred up tremendous controversy.

The Skeptics:

The naysayers maintain that female hypoactive sexual desire disorder is a primarily an invention of the pharmaceutical industry. They insist that a pink pill could not possibly fix something as complex as low libido.

Some emphasize that this is primarily a relationship issue and that if the woman’s partner was only a better lover the problem could be solved without a pricey prescription drug. The cynics insist that the serious side effects of flibanserin far outweigh its barely measurable benefits.

What is the straight and skinny on Flibanserin:

First, let’s ban the overworked phrase “female Viagra.” That is total nonsense. Drugs like sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra) do not enhance sex drive. They do improve blood flow to the penis allowing for better erections.

This is a vascular effect, meaning the drugs directly impact blood vessel physiology. Such medications do not boost libido except indirectly by allowing men to contemplate a successful sexual encounter. That might or might not improve sexual desire, but it is clearly not a direct result of the medication.

Flibanserin was originally developed as an antidepressant. It failed in that regard, but it does modify brain biochemistry. It is the drug’s impact on neurochemicals that appears to affect libido.

This medication was first submitted to the FDA for approval as a female libido enhancer in 2009. It was roundly rejected. Another attempt to get FDA approval also flopped in 2013. In essence, the experts who reviewed the drug were unimpressed with the data on effectiveness and concerned about potential side effects. Some people accused the FDA’s experts of sexism, caring more about men’s sexuality than women’s.

Many people assumed that an FDA expert advisory committee would reject the drug when it came up for its third review in June of 2015. But when the data were presented this time there was evidence of statistical significance. Not great, but women on flibanserin experienced more libido enhancement than those on placebo.

FDA staffers characterized the drug’s benefits as “numerically small but statistically significant.” What that means is that women taking flibanserin had one more “sexually satisfying event” each month compared to the women taking placebo. There was also a modest increase in feelings of sexual desire. That is all that is necessary for FDA approval.

Side Effect Uproar:

During the FDA hearings much was made of flibanserin’s side effects. Members of the advisory committee fixated on adverse reactions like dizziness, nausea, drowsiness, low blood pressure and fainting (syncope).

Now please do not get us wrong. These side effects are important and should be discussed carefully with anyone contemplating taking this drug. There should also be a discussion about alcohol, which can increase the risk of dizziness and fainting when someone is taking Addyi.

The FDA is so concerned about this interaction that it issued the following announcement:

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Dr. Woodcock is director of the FDA’s Center for Drug Evaluation and Research (CDER). This is the group that approved Addyi. What strikes us as odd is the FDA’s great concern about the drug’s side effects and potential for interaction with alcohol. There are literally thousands of drugs with far greater risk for serious side effects and drug interactions that do not have to be prescribed by “certified” health professionals and dispensed from “certified” pharmacies.

As an example, take Viagra. Side effects include:

  • Headache
  • Flushing
  • Heartburn
  • Abnormal vision, loss of hearing
  • Nasal congestion
  • Back and muscle pain

Oh, and by the way, there is a very serious drug interaction warning about nitrate-containing heart drugs like nitroglycerin. This is an extremely dangerous combination that likely surpasses the concern about alcohol and Addyi. And if Viagra is taken with certain anti-hypertensive medications it can also cause a serious drop in blood pressure that would likely cause severe dizziness.

The bottom line seems to be that the FDA is far more worried about side effects and drug interactions for a woman’s drug than for a man’s drug that has at least as many side effects and potential for drug interactions.

The People’s Pharmacy Perspective:

Flibanserin is no miracle drug to boost libido. It is certainly NOT an aphrodisiac. It may help some women who have no interest in sex but would like to enhance their libido somewhat. Hopefully this FDA approval will lead to more effective and safer drugs in the future. As for side effects, yes, the drug does have some potential to cause adverse drug reactions and interact with alcohol.

Caution is called for. But we do not understand why the FDA has made a federal case out of side effects for this drug and required only “certified” health professionals to prescribed and dispense it.

The FDA allows many other medications to be advertised on television with complications such as heart attacks, liver failure or death. Perhaps we should require all drugs with life-threatening side effects and drug interactions to be prescribed and dispensed only by “certified health professionals.”

If you would like to read more about how the FDA’s expert advisory committee reached its decision, here is a link to our observations.

We welcome your thoughts on this topic. Please share your perspective below in the comment section and take a moment to vote on this article at the top of the page.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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It’s hard to find many reviews on this. I’m beginning this med next week. I’m 37 and could care less if I ever have sex again.. I’m married.. it’s a problem! I will check back in.

Has anyone tried Addyi yet?

My wife is 62 and post-menopause. Her sexual desire has been low and dropping for over 10 years and she was tired of not have those wonderful feelings anymore.

She started taking Addyi about as soon as it was offered last fall and, actually, liked the psychological effects of the drug. She said that she it made her feel more relaxed and less edgy.

It seemed to take a couple of months for the sexual effects to start kicking in. As her sex partner, I can report that her interest in sex is real and growing. She initiates sex almost everyday and we are having a truly great time!! I’m 69, quite fit, and have a strong libido and keeping up with her is a fabulous challenge. Sex is the healthiest, happiest gift that you can give your marriage. If the chemistry of older age is causing your desire and enjoyment to wane, take advantage of this breakthrough. It works and it’s wonderful.

If estrogen levels declining are the problem then why isn’t there just an estrogen containing medication prescription? Forgive my ignorance on the subject but it seems to me that if estrogen reduction is the problem then estrogen boost is the answer…

Addyi (Flibanserin) alters brain chemistry, specifically, the neurotransmitters norepinephrine, dopamine, and serotonin. Actually the drug was first developed hoping that it would be an antidepressant medication, I guess it didn’t work out for an antidepressant, but they discovered a different use.

One thing I think people ought to think about, is:
If you take this drug for a long length of time, and then stop, will you have difficult discontinuation symptoms, like a lot of people (not all) have when they stop taking antidepressants?
What happens to women that get pregnant while taking this drug and then want to stop while they go through the pregnancy, will it make them feel awful to stop taking it?

If you are taking antidepressants, since this drug alters the same brain chemicals as many antidepressants, would there be drug interactions that would be problematic or even dangerous?

I am really curious to see how well this drug sells.

I heard on some radio show that a lobbying group was hired by the makers of this drug. The lobbying effort is said to have influenced the FDA in their approving of this drug. Have you heard anything to this effect? Appreciated the article.

This is beyond outrageous, and that women would even consider taking a drug for “low sex drive” even more so. In five years People’s Pharmacy will be listing horrible side effects from this drug too. The fewer drugs we put into/on our bodies, the better off we are. Loving partners accommodate each other’s wants and needs – this is hype created by big pharmacy.

I would like to see answers to Karen’s questions.

At the risk of sounding very cynical, I believe a man will do almost anything to regain the erections of his youth, for being a stud is very much tied into his vision of what it is to be a man. Whether or not his partner gets any pleasure is usually very secondary to him and his goals in terms of ability and pleasure. So men will shrug off the possibilities of serious side effects, both as they think of using the erectile drugs and in approving them. However, since a women’s to enjoy the sex act is secondary to him, when he sits on the approval committee he will show far more concern about side effects and less about the hoped for main effect.

Ladies, as we know sex begins in one’s head and there is no shame involved in reading today’s soft porn, if it sets a mood. You also have your own hands. Plus, your partner will be more satisfying to you if you tell him what you want.

I can’t imagine why every single discussion on female sexuality fails to mention the obvious. Female desire in general is linked directly to the fertility cycle, just as nature intended. Once estrogen reduces, obviously desire reduces.
Affection, appreciation, a skilled sex partner, drinking champagne — all have their part in raising desire in the climate of estrogen reduction.
Take all the brain pills you want, but an unskilled or inconsiderate sex partner allied with the female estrogen reduction of aging, and the situation essentially remains unresolved.
So, I suggest that taking this medication should be linked to relationship counseling.

I was going to write you a personal email asking what your thoughts were on this new drug, but saw that you wrote about it in today’s newsletter!

I am so glad that you stated you did not understand why the FDA made a big deal over the side effects of this particular drug and not any of the others. One group close to my heart are the Fluoroquinolone antibiotics such as Cipro, Levaquin, Floxin and Avelox to name a few. There are so many people with such horrible devastating life long side effects from this group of antibiotics which the FDA is totally aware of, yet not a word of warning from our doctors is given. Most doctors aren’t even aware of the black box warnings and the FDAs August 2013 warning of permanent peripheral neuropathy . The doctors would say they were “rare” occurrences anyway.

I personally don’t think a signed consent to take this new drug or any drug for that matter does any good other than cover the doctor’s and pharmaceutical companies tushies!!!

I appreciate your thoughts about the difference in attitude toward the side effects of this drug vs. those of Viagra etc. ….But I don’t understand what distinction the FDA is requiring for prescriptions. Is a “certified health professional” the same as a medical doctor or nurse practitioner? Is a “certified pharmacy” the same as the pharmacy at Walgreens? Where could you get a prescription drug if not from a “certified” health provider or pharmacy?

Comparing the risks of drinking alcohol while taking Addyi with the risks of taking Viagra while taking prescription medicine for hypertension is misleading. Drinking alcohol is far more common and embedded in the social world, so far more likely to happen. This article fails to convince when it provides useless comparisons like this.

I’m a 63 year old female who used to love sex. I have no desire for sex at all. My husband has a strong sex drive. I would love to have the desire for sex with my husband and would welcome any help in having the desire to do so. The lost of desire in women my age and even younger is more common than you would think. In fact more women than men lose the desire with age. It’s about time someone listen to women’s issues with the lost of desire. I’ll be the first one in line for the new medication!

Agree -I would love it too. But this isn’t it.

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