Health: Addyi: Pink Viagra, or did the FDA get bamboozled | PostIndependent.com

Health: Addyi: Pink Viagra, or did the FDA get bamboozled

Phil Mohler, M.D.
MOHLER’S MEDICATION MAXIMS

Addyi has been described as the “biggest breakthrough for women’s sexual health since the pill” and alternatively, as “the sham drug of the year.” It is a new drug that effects the balance of chemicals in the brain (dopamine, norepinephrine and serotonin) that control sexual excitability and inhibition. Addyi is specifically indicated for premenopausal women with loss of sexual desire that causes them marked distress, but is not the result of illness, relationship problems or side effects of other drugs. The syndrome is labelled, “Hypoactive Sexual Desire Disorder” (HSDD).

The facts about Addyi

1. The dosing is one tablet, once a day, everyday, at bedtime.

2. The studies on approximately 8,000 women (paid for by Sprout) show that only 10-12 percent of all Addyi takers got any benefit at all. Those patients who did have a positive response had 0.5-1 additional sexually satisfying events per month compared with placebo.

3. The common side effects are nausea, lowered blood pressure, dizziness and fainting.

4. The FDA includes a Black Box warning that Addyi should not be used with alcohol. Women in the studies who consumed alcohol with Addyi had increased risks of lowered blood pressure and fainting.

5. Ms. Whitehead, Sprout’s CEO, estimates that Addyi will sell for $400 per month. She reports that pricing is based on what a month’s worth of Viagra would cost. (That’s 2-3 times as much as the average man spends on Viagra per month.) $400 seems a felicitous price for Sprout, but not a very pocketbook friendly one for the women Sprout indicates it is trying to serve.

My Take:

First as a disclaimer, I confess that my knowledge of women’ sexual dysfunction and of women, in general, is scanty.

In reviewing the literature for this article, it is readily apparent that there is a great deal of controversy over whether HSDD should be treated with medicines or counseling or reading erotic literature or none of the above.

Addyi is NOT pink Viagra. Addyi is about brain juices and desire, not blood hydraulics and performance like Viagra.

It is comical to think that the FDA or pharmacists or clinicians can help patients separate sex and alcohol.

Think value! Is it of value to you to spend $400 a month for a 90% chance you will get no benefit from a drug, but be exposed to all the potential side-effects?

The FDA got it right the first two times they turned Addyi down. Are there gender inequalities in medicine? Absolutely. Addyi will not even any score.


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