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'Female Viagra' Approved by FDA -- But Wait -- All That Glitters . . .
From:
Barbara Morris - Pharmacist - Writer - Aging Issues Barbara Morris - Pharmacist - Writer - Aging Issues
Escondido, CA
Saturday, August 29, 2015

 

 

Note: While I have taken a somewhat snarky approach to this subject -- make no mistake -- this is a potent drug with potential for lawsuits, personal injury -- or worse.


The good news: The FDA has approved flibanserin (Addyi), the first drug to treat premenopausal  women with low sexual desire. The appropriately colored pink pill has been described as the female equivalent to the  erectile dysfunction drug, sildenafil (Viagra).

(Sorry, postmenopausal girlfriends. You will have to continue to rely on the prowess of your partner to rev you up. It might be as easy as a bouquet of flowers, or if your partner showers more than once in a blue moon and shaves the thorny shrubbery off his face.  Girlfriends, am I right about that?)

The bad news: Addyi is not for patients with liver impairment and the medication carries a Boxed Warning about the risks of severe hypotension (low blood pressure) and loss of consciousness among those who drink alcohol. (If this warning is not a red flag for disastrous behavior in bars, what is?) 

Of course, it's comforting to know that because of the label warning, Addyi will only be available through certified health care professionals and certified pharmacies. (Sure, like you can only get Oxycontin on prescription -- unless you know a street dealer.)

My vision of what COULD happen:

Ultimate optimist that I am, because of the government's super success in stopping illegal drug use, I anticipate  creation of a new federal bureaucracy, staffed with government agents paid at least 100K a year (big brothers/sisters --  like Obmacare Navigators) to oversee and monitor premenopausal revelers at bars and other venues where alcohol is served. This could be paid for by tax hikes and/or cuts in Social Security or Medicaid. 

To avoid lawsuits, and before dispensing drinks, bartenders would have to be trained,  credentialed,  and required to administer blood or saliva tests to premenopausal women to detect the presence of Adddyi (creating yet another costly, useless level of bureaucratic "healthcare"). Furthermore, bartenders  would be held responsible for Addyi being slipped into a woman's drink by nefarious types that infest bars. Surely, one can see the endless possibilities and opportunities  for government intervention  in the lives of  premenopausal women in an attempt to protect them  from themselves and from predators.

Back to reality: Addyi was approved with a Risk Evaluation and Mitigation Strategy (REMS) because of risk of severe low blood pressure and loss of consciousness. Prescribers of Addyi must be certified with the REMS program and complete training. They must also use a Patient-Provider Agreement form to emphasize the risks of drinking while taking Addyi. Pharmacists are responsible for counseling patients prior to dispensing about the importance of alcohol abstinence. (As if pharmacists do not have enough counseling responsibilities already). 

Question: What is it about this medication that requires physicians to be specially trained and  certified in order to prescribe it? Is it that potentially dangerous? Many medications have potentially serious side effects but physicians are not specially trained to prescribe them. 

Around 2400 premenopausal women took 100 mg of Addyi in 3 24-week placebo-controlled trials. Around 10% of the women in the trials reported meaningful improvements in sexual events, desireor distress. (The nature of the "distress" was not revealed.)

Seriously, 10% is not a great result considering potential problems with careless or illegal use of the drug.

 The cost is anticipated to be around $400 a month and must be taken daily so the annual tab could be around $5,000 a year. Typically, health plans do not cover "lifestyle" drugs.

Online Dating For Older Women: The Good, Bad, and The Ugly

Barbara E. Joe, writer, Spanish interpreter,  long time Peace Corps volunteer and single older woman has written a personal and revealing piece about her experiences with  online dating. It's  lengthy (8,000 words) and if you would like a copy at no cost you can download it  here

News Media Interview Contact
Name: Barbara Morris, R. Ph.
Title: Editor, Publisher
Dateline: Escondido, CA United States
Direct Phone: 760-480-2710
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