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

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.

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