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“Female Viagra”: Women, Just Say “NO” To Addyi.

As a pharmacist and a long-time supporter of women’s health issues, I feel compelled to speak out against Addyi, which is the new drug that was recently approved by the FDA to treat women with Hypoactive Sexual Desire Disorder (HSDD).

Addyi, a pink pill with the generic name  flibanserin, is being called “pink Viagra” or “Viagra for women.”  Addyi was initially developed by the German pharmaceutical giant Boehringer Ingelheim as an antidepressant in the 1970s. However, the F.D.A. declined to approve flibanserin as an antidepressant which caused Boehringer Ingelheim to abandoned the drug.

Two individuals with extensive experience in the pharmaceutical industry formed a small startup company named Sprout Pharmaceuticals with the expressed purpose of breathing new life into  flibanserin. Cindy and Robert Whitehead acquired the rights to flibanserin and presented it to the F.D.A. for approval as a libido-boosting pill for women. Result: rejection #2 by the F.D.A.

Undaunted by rejections based on weak science, Sprout Pharmaceuticals shifted gears and mounted a public relations campaign pressuring the F.D.A. with public opinion using “gender equality” arguments. The company engaged feminist groups for a campaign called "Even the Score" using TV documentaries and well orchestrated demonstrations claiming new the sex pill was an equal rights issue for women. One of the feminist group’s WEB sites accused the F.D.A. of sex-drug sexism pointing out that there are 26 FDA-approved drugs to treat various sexual dysfunctions for men but still not a single one for women’s most common sexual complaint.

The social pressure and misleading propaganda worked. In August 2015, the FDA advisory panel, which had twice previously rejected Addyi, approved the drug for Hypoactive Sexual Desire Disorder.  

Benefits: Based on the results of 3 clinical trials, Addyi’s benefits are minimal at best. On average, women selected for the trials reported an average of 2.8 “satisfying sexual events” per month before the clinical trials began. During the trials, women taking a placebo reported 3.7  “satisfying sexual events” per month while women taking Addyi reported 4.8 “satisfying sexual events” per month. So, women taking Addyi (an SSRI-like antidepressant) had less than one (an average of 0.8) more “satisfying sexual events” per month compared to women taking the placebo. Subjecting yourself to potentially long-term antidepressant side effects for such a paltry gain doesn’t seem like a good idea to me.

Side Effects: The F.D.A. rejected Addyi twice based primarily on safety concerns.  Many critics are not convinced that Addyi’s benefits outweigh its risks. In large clinical trails, 11% of women experienced dizziness, 11% experienced drowsiness and 10% complained of nausea. Additional reported side effects include fatigue, insomnia and dry mouth.

Addyi can also cause a dangerous drop in blood pressure that could cause a brief fainting spell. The term for this condition is syncope, which refers to a brief loss of consciousness. Syncope is due to a decrease in blood flow to the brain. These episodes generally happen quickly and have a spontaneous recovery. However, you can see that this could cause serious problems if an individual has a brief fainting spell while driving at 65 miles per hour on the freeway.

Alcohol:   There is also a potentially serious interaction with alcohol. Since sexual activity frequently coincides with alcohol consumption, this is a problem that warrants concern. The F.D.A. required Sprout Pharmaceuticals to include the following “Black Box” warning:

The use of Addyi and alcohol increase the risk of severe hypotension and syncope; 

therefore, alcohol use is contraindicated.

I am also puzzled by the fact that the research examining the side effects that can happen when you mix Addy with alcohol was conducted mostly on men…???  Why would you use men to test the side effects of a drug that is solely meant to be prescribed for women?

Dosage & Directions: Addyi is available in a 100 mg pink tablet. The recommended dose is one tablet daily taken at bedtime. Why does the manufacturer recommend taking Addyi at bedtime? Because taking Addyi during waking hours increase risks of injury from a sudden drop in blood pressure and/or central nervous system (CNS) depression.

Mechanism of Action: Addyi is not anything like Viagra. Viagra’s effect is on the male sex organ, increasing blood flow to the penis. Viagra does not increase a man’s sex drive, it just facilitates achieving and maintaining an erection. Addy does not act on a woman’s genitals, it is an antidepressant that works on a woman’s brain. 

Addyi the Antidepressant:  Addyi is basically an antidepressant somewhat similar to the SSRI antidepressants because it specifically targets serotonin receptors. However, the manufacturer admits that the mechanism that enables Addyi to improve sexual desire is not known.

Although proponents are calling Addyi the “female Viagra” critics are calling it the “little pink problem.” Critics claim the theory proposed to gain Addyi’s F.D.A. approval has been debunked and its side effects (like fainting) could cause deaths.  

Why Am I Voicing My Concern: Most antidepressant drugs cause serious and long-term side effects. In some respects, antidepressants might be viewed as highly addicting drugs. Many people who try to discontinue these drugs experience a horrendous rebound depression that forces them to go back on the drug. 

I recently launched a 4-hour online course titled Natural Therapies for Depression & Anxiety. In this course, I discuss the serious side effects and controversies related to these drugs and offer a wide range of safe effective natural therapies. This course can be accessed through my WEB site, NaturalPharmacist.net or from the link below:

http://naturalpharmacist.net/?post=online-seminar-natural-therapies-for-depression-anxiety

Addyi gained F.D.A. approval based on three 24-week clinical trials. In my opinion, this is not long enough to adequately assess the drug’s potential long-term side effects. Also, the clinical trials did not report mention what problems were experienced when women discontinued the drug.  

Improving Sexual Desire: There are many safe non-drug ways for women to improve sexual desire and satisfaction. I recommend psychotherapy and/or some sessions with an experienced sex therapist. I also advocate checking levels of the hormones estrogen, progesterone and testosterone. 

Orgasmic Meditation: Another “process” that has been very helpful for couples seeking to improve their sexual experiences is called Orgasmic Meditation or OM. This process was popularized by Nicole Daedone. I recommend watching Nicole’s wonderful TED talk at:

http://tedxtalks.ted.com/video/TEDxSF-Nicole-Daedone-Orgasm-Th

After watching Nicole’s TED talk, I recommend that women (or couples) watch a well-produced Youtube video that shows a couple providing Step-By-Step instructions on how to do the Orgasmic Meditation process:

https://www.youtube.com/watch?v=-86ZJvBBnNU

Sprout Pharmaceuticals Sold: One final note. Sprout Pharmaceuticals reportedly raised about $50 million to start the company and launch Addyi. Shortly after the F.D.A. approved Addyi, Valeant Pharmaceuticals purchased Sprout Pharmaceuticals and Addyi for $1 billion. Pretty good profit for investors on a product that can potentially harm a lot of women.

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© 2016 ROSS PELTON