Finally, women get a “pink pill”!!!! Sprout Pharmaceuticals Receives FDA Approval of ADDYI™!!!!!!!!!!!!! - Ellen Dolgen

Finally, women get a “pink pill”!!!! Sprout Pharmaceuticals Receives FDA Approval of ADDYI™!!!!!!!!!!!!!

Sprout Pharmaceuticals receives FDA Approval of ADDYI™!!!!!!!!!!!!! First-ever FDA-approved treatment for women’s most common form of sexual dysfunction, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is a persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and cannot be accounted for by another medical condition or substance. Addyi (pronounced add-ee), known generically as Flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite.  It is a once-daily, non-hormonal pill. It is estimated that 8 to 14 percent of women ages 20 to 49 have the condition, or about 5.5 to 8.6 million U.S. women.   I understand that doctors must rule out many issues before diagnosing the condition, including relationship issues, medical problems, depression and mood disorders. Hmmmmmmmmmmmmmmmmm, I was just wandering if these same issues also have to be ruled out before the “blue pill” is prescribed for men????????????


22 thoughts on “Finally, women get a “pink pill”!!!! Sprout Pharmaceuticals Receives FDA Approval of ADDYI™!!!!!!!!!!!!!”

  1. The gate has been opened and for that we should all be grateful. However, it’s likely to be slow going getting it covered by insurance companies and for docs to script it. Still….it’s a step in the right direction!

    1. I am happy the gate was opened! From what I have read, the company is hopeful that many insurance companies will cover the new drug to the same level they cover drugs like Viagra. They are thinking if it IS covered, it most likely will cost women between $30 and $75 a month in out-of-pocket costs. The company may consider offsetting the expenses for women who don’t have insurance so it doesn’t cost them more than that.

  2. YOu know,I have mixed feelings. I am not willing to take any more meds than I have to these days. I just don’t think we know enough about effects and I do think the FDA is corrupt. Plus I think we are way too reliant on a pill to fix everything. So I would try every other thing possible before I’d take this.

    1. I understand what your saying, Carol. However, research and medical advances help us live happy, healthier lives. Probably if it weren’t for the Statin drug…I would not be alive today. When I was a teenager, it was discovered that my cholesterol levels were literally off the charts. My Dad died at 58 due to blocked arteries. His parents did not live to see 60 either. I was put on a heart healthy diet and exercised, but my cholesterol was still at dangerously high levels. I am going to be 62 in a few weeks, primarily because of the Statin drug that I have been taking daily since it was FDA approved. Modern medicine has saved my life. The more options for women suffering from this most common form of sexual dysfunction, the better!

  3. Please note, approved for premenopausal women. It would also be useful to include info on the efficacy of this drug i.e. how many more sexual ‘urges’ per month than placebo…..

    1. Yes, Catherine, I did make sure to note that is has been approved for premenopausal women in the Health News Flash. However, I have heard some doctors mention that they think the use my expand. I linked to the New York TImes article that did go into more detail on efficacy.

  4. Too many potentially dangerous side effects such as seriously low blood pressure, fainting, nausea, dizziness. There’s already concern about it being used as a new “date rape” drug. Also, it has only been shown to have limited efficacy. Not to mention it’s only approved for PREMENOPAUSAL women! What the heck? I guess it’s a start but, really, can we not do better with all our advanced technology and the millions of dollars spent on pharmaceutical research??

    1. Carol, often these drugs start out with huge controls and stipulations as a cautionary measure. It will remain to be seen how this drug progresses and it’s uses. As for the side effects…. The lists are soooooooooooooooo long. Everything has side affects. Here is the list of side affects of my thyroid medicine that I take daily. No pun intended!
      Chest pain or discomfort
      decreased urine output
      difficult or labored breathing
      difficulty with swallowing
      dilated neck veins
      extreme fatigue
      fast, slow, irregular, pounding, or racing heartbeat or pulse
      heat intolerance
      hives or welts
      increased blood pressure
      increased pulse
      irregular breathing
      menstrual changes
      pain or discomfort in the arms, jaw, back, or neck
      shortness of breath
      skin itching, rash, or redness
      swelling of the eyes, face, lips, throat, or tongue
      tightness in the chest
      troubled breathing
      Blurred or double vision
      eye pain
      lack or slowing of normal growth in children
      limp or walk favoring one leg
      pain in the hip or knee
      severe headache
      I have never experienced one! That being said, I agree with you – women’s health research is behind!

  5. Thank you Ellen for this great new info! Thankful the people in the white lab coats finally figured out that women need help in this area too…! DUHA!

  6. My husband has worked in pharma for 20 years. An important thing for us all to know is that the FDA requires pharma to list a side effect even if it only happened to ONE person in all the people in all the clinical trials the drug must pass before it’s on the market. That means that the side effects that MAY occur in less than 1 percent of the population are required to be listed (hence, Ellen’s long list of side effects in previous comment!).

    While doctors will first rule out other issues before diagnosing anything, pharma doesn’t get that chance. The one person who had that side effect may have gotten it from any number of other factors, but we’ll never know.

    I’m not currently taking any med’s, and I could experience a few of those side effects Ellen mentioned in any given week! It’s always good to do your research, talk extensively to your doctors, and make a decision that’s right for you and your quality of life. There are many alarmist voices out there, some legit and some not!

    1. Cheryl, thank you so much for taking the time to shed some light on the protocol for side effects. It is extremely helpful to us “lay people”. I feel that my role is to help makes sure women understand ALL of their options so that together with their healthcare professional, they can make the best decisions for their individual health needs. Of course, these options are constantly changing as new scientific research and discoveries are uncovered. Again, thanks for the great info!

  7. Hi Ellen,

    I was wondering if you or any of your readers would kindly give any recommendations for dry hair? My hair used to be oily and now that I’m menopausal, it’s very dry and has frizzy ends. My hair person is not helpful and I’ve tried several shampoos and conditioners.

    All the best,

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