Tuesday, March 24, 2015

Risky Business

Often drugs presented before the FDA are rejected due to the "risks" associated with the drug or the "risks" not outweighing the "benefits".

A few years ago I was on the clinical trial for Flibanserin, which I found not only to be extremely effective at improving my medically diagnosed HSDD but also very well tolerated.  Sadly, the FDA thought differently and has sighted "risks" outweigh any "modest benefit".  

Well, why don't they ask my husband!  He will tell you that "modest" is in the eye of the beholder and what we experienced was far greater than modest!  But even if it was "modest" to some, I would dare say any couple who went from monthly sex to bi-monthly sex would not consider that "modest".  As a matter of fact, that is a 100% increase in frequency.

As we have continued in our journey and read with interest and shock some of the grossly inaccurate opinion pieces with regards to flibanserin, I have often wondered why all the critics seem to be those who NEVER TOOK THE DRUG and often do NOT have a clinical diagnosis of HSDD!

Would it not make more sense to listen to women who ACTUALLY took the drug???

As I watch tv at night and talk with friends, the subject often ends up on drugs and side effects because this is clearly high on my interest level.  And as we discuss common, every day medications that we all take, I began to research what side effect baggage they bring to the table.  Interestingly, the same "benign" side effects of flibanserin but more frightening, several have far more serious and often irreversible side effects.

I have listed a few of these very commonly prescribed products and links to their Package Inserts that accompany each prescription.

Headache and nausea top the list on just about each of these - and just about every drug out there I believe.

What is disturbing is that some of these carry risks that in no way, outweigh, the benefits!  At least not in my mind!

I have listed a few other side effects that I find difficult - if not impossible- to believe any woman would consider "worth the risk" when having to use an off label product for HSDD because there IS NO FDA APPROVED treatment for us!  Many of these drugs are indicated FOR MEN, not women.  Others are used OFF LABEL and we are used as guinea pigs to find an acceptable dose.

Penile Rupture??  Irreversible hair growth? Worsening acne? Fluid retention?  Anxiety? Epigastric distress in 83% of patients???

Let me ask you!?  If you are a woman experiencing HSDD and approaching mid life, do you need any more fluid retention?  Are you not anxious enough?  Belly not give you enough issues as it is?  A couple of chin hairs maybe, but are you willing to grow a goatee in exchange for possible benefits of testosterone?

For me the answer is NO!

WOMEN DESERVE an FDA approved treatment for HSDD to help EVEN THE SCORE!!

Well, that may be a stretch.  26-1 will hardly be evening the score.  But it will be a step in the right direction!!



Effexor
http://labeling.pfizer.com/ShowLabeling.aspx?id=100

Viagra
ttp://labeling.pfizer.com/ShowLabeling.aspx?id=652

Androgel ( off  label for women )
http://www.rxabbvie.com/pdf/androgel_PI.pdf

Xiaflex
https://www.xiaflex.com/_assets/pdf/XIAFLEX-PI-and-MedGuide-Combined-20131206-ver-e.pdf

Testosterone ( off label for women )
http://www.drugs.com/pro/testosterone-cypionate.html

Aspirin
http://www.drugs.com/pro/testosterone-cypionate.html

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