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That Pink Pill: Do You Need It? Does It Work?

Aug 03, 2016 02:00PM ● Published by Cate Reynolds

By Lisa J. Gotto

Billed as the “First of Her Kind,” flibanserin or Addyi, now more famously known as the “pink pill for women,” has officially been on the market since the summer of 2015. You may be surprised, however, what it actually addresses and to whom it’s being marketed.

It was inevitable that once the pharmaceutical industry developed a pill to enhance the sex drive of men, that a female libido drug would also be available at some point. While it was inevitable, it wasn’t necessarily fast-tracked—nearly 20 years has passed since Viagra was introduced.

Good news, bad news

With the introduction of Addyi came a glimmer of hope for women everywhere who suffer from a compromised sex drive, especially for post-menopausal women—or so we first thought. Research shows that up to 40 percent of women experience a decrease in libido in their post-menopausal years. The drug, however, was not developed to address the waning sex drive of women in this group.

Makers of the drug, Sprout Pharmaceuticals were quick to point out the fact that the pink pill they developed was NOT the female version of Viagra. (The company Sprout Pharmaceuticals has since been bought by Valeant Pharmaceuticals for $1 billion with Sprout becoming a division of Valeant.) Rather, that it would address the lack of libido for women in their childbearing years, focusing on what has been identified by some in the medical community as an underserved segment of the female population.

What causes low libido in women? While some cases can be traced to the side effects associated with birth control pills and anti-depressants, there are also cases that have no clearly definable cause and have occurred in women who had no previous experience with this condition. The condition is now medically recognized as Hypoactive Sexual Desire Disorder, or HSDD. Women diagnosed with the disorder often report their main concern is the stress it creates within their personal relationships.

Addyi, or flibanserin, works over time to modify the level of the chemical serotonin in the brain that helps relay and enhance sexual response. Definitely unlike male ED drugs which work quickly and directly to increase blood flow throughout the body. The drugs are inherently as different as male and female physiology is.

Not without controversy… and side effects

As far as the Food & Drug Administration (FDA) is concerned, Addyi should not be considered an aphrodisiac in any regard. In fact, the agency took a considerable amount of time approving Addyi for use in the U.S. and only did so with strict controls in place as to who can prescribe the drug and for what purposes.

According to the FDA, “Addyi is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

  1. A co-existing medical or psychiatric condition
  2. Problems within a relationship
  3. The effects of a medication or other drug substance

So if you are in a relationship that has run its course, you are experiencing pain during sex, or have other life problems complicating your romantic life, Addyi is not for you.

Addyi is not to be prescribed for cases that are traceable to the side effects of anti-depressant meds or birth control pills.

The backstory on Addyi is rife with issues—being turned down by the FDA for approval twice, once in 2009 and again 2013, was perhaps a precursor to what is currently going on with the drug. Both attempts to get Addyi approved were thwarted over concerns with its efficacy and its side effects.

A recent review on Addyi published in JAMA Internal Medicine reports the benefits of the drug as minimal. The study was based on eight clinical trials with 6,000 women participating. On average the women reported having 2.5 satisfying sexual events per month prior to taking the drug, and added just one-half of an additional satisfying event per month after taking Addyi. (Note: if you are scratching your head about how you would even calculate half an “event” of this nature, you are not alone.)

The most nagging concern for medical professionals is a lack of research when it comes to the long-term use of the drug and its subsequent reactions with other drugs being taken by the user or other health conditions she may have.

Not to mention, some in the medical community feel there is a political component associated with the approval of this drug. An advocacy group consisting of 26 organizations known as Even The Score has been lobbying hard to “level the playing field” when it comes to matters relating to women’s sexual health including sexual dysfunction.

This group was reported to be highly active during the period when the FDA last turned down the use of flibanserin in 2013, and then when it was finally approved for use in 2015. Part of the FDA’s approval was contingent on a strict prescriber and pharmacy control program being in place for the drug. This is known as a “REMS” or Risk Evaluation and Mitigation Strategy where prescribing physicians and participating pharmacies must first participate in a training and certification protocol before they are approved to prescribe and then dispense the drug.

Again, this is a very different protocol than is followed for Viagra, for instance, but there is enough medical data in place to substantiate its adherence and its importance.

Can you benefit from Addyi? Possibly. Only your doctor can answer that question and that occurs only after a thorough evaluation of your situation and the drug’s pros and cons.

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1. Addyi is NOT approved by the FDA for use in post-menopausal women, although some industry experts predict “off-label” use of the drug is not out of the question down the road for some post-menopausal women.

2. The Cleveland Clinic reported in 2010 that millions of American women are affected by low sex drives.

3. Know the Side Effects:
  • Dizziness
  • Sleepiness
  • Nausea
  • Fatigue
  • Insomnia
  • Dry Mouth
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