The FDA approves first treatment for sexual desire disorder.

One of the most common complaints that we hear at the office is decreased libido or loss of sexual desire.  Honestly, we all go through times ourselves when the desire is just “not there”.  Many have asked for medicinal help but until now it was not available.  Viagra has been on the market for a while now for men.  Now, there is something new for women to try.  This week The U.S. Food and Drug Administration (FDA) approved the first treatment for sexual desire disorder for women.  Here is what they say about this “miracle” drug.

The U.S. Food and Drug Administration approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.

Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.

Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Addyi is contraindicated in these patients. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation). Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. In these trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding four weeks (scored on a range of 1.2 to 6.0) and reported distress related to low sexual desire (on a range of 0 to 4). On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo. Additional analyses explored whether the improvements with Addyi were meaningful to patients, taking into account the effects of treatment seen among those patients who reported feeling much improved or very much improved overall. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance.

The 100 mg bedtime dose of Addyi has been administered to about 3,000 generally healthy premenopausal women with acquired, generalized HSDD in clinical trials, of whom about 1,700 received treatment for at least six months and 850 received treatment for at least one year.

The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.

The FDA has recognized for some time the challenges involved in developing treatments for female sexual dysfunction. The FDA held a public Patient-Focused Drug Development meeting and scientific workshop on female sexual dysfunction on October 27 and October 28, 2014, to solicit perspectives directly from patients about their condition and its impact on daily life, and to discuss the scientific challenges related to developing drugs to treat these disorders. The FDA continues to encourage drug development in this area.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Addyi to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
What do you think?  Will you give it a try or wait and see what others have to say?  Let us know your thoughts.  We will also follow up with some patient testimonials soon!
Tanya Bolton
Lexington Women’s Health

Humid, Hot and Carrying Child?

Excessive heat and humidity can be hard on anyone. Pregnancy only intensifies those feelings. If you are due in the summer or early fall, you can relate. You don’t have to have a miserable summer, but you do need to take a few extra precautions.

First of all, and I cannot reiterate this enough, keep yourself hydrated. That means making sure you drink plenty of fluids.  Water is best, but so are occasional juices and sports drinks which replace electrolytes that are being sweated away. Infuse fruits into your water to give it more taste if you need to. You do not want to let yourself get dehydrated. It can worsen pregnancy aches like swelling and can even trigger preterm contractions, so drink up!

During pregnancy, many women have increased sensitivity to the sun. This means you might burn more easily and may need to wear more sunscreen than usual.  Basically, you should never leave the house without wearing sunscreen with an SPF of at least 30. Make sure you cover all of your skin. Don’t overlook ears, neck or feet and remember to reapply every few hours and after swimming or towel drying.

Don’t rely on sunscreen alone to keep your skin protected.   Wear loose, lightly-colored clothing. This reflects the sun’s rays rather than absorbing them as dark colors do. Cotton, linen and natural fibers are best because they are light, airy and comfortable.

Wear a hat. The best choice is a hat with a wide brim that covers your face and neck. That fact that these are very fashionable at the moment is just another perk. The same can be said about a good pair of sunglasses. Don’t feel guilty about spending a little extra on a good pair of UV- filtered sun glasses.  They protect the eyes from painful sunburns, cataracts, and glaucoma.   Also, the skin around the eyes, including the lids, is one of the most prone areas to skin cancer!

Go to the pool!  If you’ve got a pool, use it often. If you don’t have one, get a large inflatable pool. These are relatively inexpensive and can hold several people. You’ll love the option of going to your back yard and relaxing in the cool water. If you have other children at home, they will love it too!  Now is not the time to consider tanning or laying in the sun – stay in the shade. A big umbrella with a glass of ice cold water should be your “go to” destination. If possible, use a canopy or position umbrella over the pool for the ultimate pregnancy paradise.

Sometimes, it’s better to just stay indoors.  If it’s too hot (heat index in the 90’s) stay inside with air conditioning. If you must go out, try to limit the outside activity to the cooler parts of the day such as early morning or evening. Also, carry a spray/mister bottle around with you. Nothing feels better than a cold mist on your face, forehead and neck.

All of these tips are simple to do, but sometimes it’s hard to know when you’ve been out too long. Get indoors at the first sign of dizziness, fatigue or excessive thirst. Lie down in a cool area and hydrate. If you don’t feel better soon, call your provider.

See you at the pool!

Tyler's CNM Photo

Tyler Halvaksz, CNM

Lexington Women’s Health

Mother’s Day 2015

Around here we celebrate Mother’s daily.  We are fortunate to be able to help many women on their journey to motherhood.  Mom’s and Moms-to-be should all be appreciated. After all, they give life!  Many of us are now Mother’s ourselves.  So this year not only are recognizing all the amazing Mother’s out there but we also get to share in the celebration.

This Mother’s Day we decided to write letters to our children.  Yes,  we all want flowers, candy, a card…something.  It just makes you feel recognized.  But honestly, our children are more of a gift that we ever imagined.

Here’s a few of our letters.  Hope they bring a smile to your face and warm your heart.  Happy Mother’s Day.

To my daughters,

My mom always told me “ You will understand when you have a daughter” and boy has this proven to be true.  You girls are such an amazing blessing to me and I cannot tell you how wonderful it is to be your mom.  Every day the first and last thing I do is thank God for each of you and to help me guide and protect you through the day.  You will hold my heart forever and I would give up everything for you.  I hope to one day be able to guide you through motherhood the way Nana does for me now.  Life will give you happiness, sadness, disappointment and extreme joy and I will  be right there for all of it.  We will have ups and downs but always know your momma will be with you every step of the way.  My love is endless and unconditional and with God’s guidance we will enjoy this life as Mother and Daughter.  I love you Alora and Addison with all that I am.

Mom

(Stacie Wilson, RT(T) RDMS  Ultrasound Supervisor)

To B &K,

It wasn’t until the day I found out I was expecting that I really knew what my purpose in life was going to be.  In honor of Mother’s Day I thought instead of it being about me, I would let you both know why it really is all about you.  From day one, the first breath you took, the first time I got to hold you, feel you, smell you, kiss you, you became my life.  In one instant all my hopes, joys, and even fears were unleashed.  Before I met you two, the word responsibility meant getting to work on time. Now it means guiding, feeding, teaching, protecting these two beautiful children, who are completely dependent on us for everything. The truth is, I’m more than okay with that and I want to do it for the rest of your lives. I hope you know:

  • If I could hold your hand through all the scary parts of this thing called life, I would. If I could save you from every fall and swat away every insult, I would. If I could wipe up every tear and take away all your heartbreak and disappointments, I would. And when those times come, I will always be here.
  • I’m on your side, no matter what. Even when you’ve done something so stupid, which believe me you will, you can always come to me and I will help you. We will get through it together.
  • Be the hero! Unfortunately there are some cruel people in the world.  Stand up for what’s right and never be afraid to stand up for someone else! Be brave, be kind, be a light.
  • You can do things, Even the hard things.  If you fail, try again. Never, ever be afraid to try.
  • And last but not least smile, laugh, hug and love! Don’t take life too seriously.  Every day wake up and choose to be happy.  Your smiles are infectious. Share them with the world.

You’re going to grow up sooner than I’d like.  Some days you’ll love me. Some days you won’t (well, you’ll tell me you won’t but I will know better). Some days I’ll cross your mind. Some days I won’t. But years from now, I hope you know that throughout it all, I tried my best, worked my hardest, and loved you with everything I have.

Whether it’s our seasonal “To-do lists” or carrying on Dance Party Fridays on our morning drives to school, all I wish is that one day, you truly understand how I feel about the two of  you.  Being your mother is my greatest accomplishments and I will forever be grateful to you for giving me that gift.

I love you to the moon and back,

Mom

(Sarah Guildbault, Front Office Manager)

Dear K & K,

My love for each of you is something you will never truly comprehend until you have children of your own. How do I know this? Because it is something my mom use to tell me. On this mother’s day I want each of you to know that I love you with all of my heart and soul and everything I have to give and I want to celebrate the both of you. Being your mother is the greatest gift of all and I am honored to be called your mom. I thank God every day for blessing me with two wonderful children and I ask him to watch over and protect each you and for guidance as I go through this crazy thing called parenthood. There will be days that you will question my love and days you are mad at me, but just know no matter what my love will never change.

On this mother’ s day I would also like to thank each of you for the simple things you all do that mean so much to me. Thank you for kicking me throughout the middle of the night and for the very few hours of sleep I get. Thank you for our bath times, but most of all thank you for the little fingers that’s underneath the door trying to get in on the few times we do not bathe together. Thank you for ruining my shirts when you go to lay your head down on my shoulder with your dirty faces. Thank you for spraying me with cold water at the kitchen sink as I try to cook. Thank you for spitting up on me as I rock you to sleep in my arms. Thank you for all the slobbery wet kisses and the best bear hugs ever, and if it ever seems as though I am holding on a little tighter, it’s because I am. I know that one day those hugs and kisses will be few and far between. Thank you for showing me love in a way no one ever has. Thank you for loving me through my flaws and imperfections yet still thinking I am the best mom ever. Thank you for making me smile when I walk through the door after having a bad day. Thank you for making me the happiest person in the world knowing I have you guys to wake up to. Thank you for being my children.

As time continues to fly by there are a few things I want you guys to always remember. First and foremost keep God first in everything you do. Be kind. Be the first to forgive. Respect yourselves and never settle for less than you deserve, which is the best.  So on this mother’s day and every day forward just know how much I love you and how proud I am to be your mom.

Love,

Mom

(Chasity Clark, Clinical Assistant)

To my daughter

I could never image how much I could love someone till I had you! You may push my buttons and make me want to pull my hair out… J but I wouldn’t have it any other way. You are such an independent little girl for 2 years old which is incredible however very stressful and exhausting for Mommy! But I hope you keep that trait and become a successful and independent women in whatever you do. It’s astonishing how fast you developed such a spunky and outgoing personality and never miss a moment to make me laugh. It’s also so crazy how little you are and bring so much joy into to so many people life’s. I couldn’t have made a more perfect child if I tried and I am so blessed God decided I could be your mother. I am not perfect but you are the light of my life and make me strive to be a better person. “So much of me is made from what I learned from you, You are with me like a handprint on my heart”  -Author Unknown

Mommy

(Michelle Martin, RT(T) RDMS  Ultrasound Department)

Dear A,

Mother’s Day is set aside to honor Mothers for what they do and who they are.  But, if it wasn’t for you, I would not be part of this holiday.  I want you to know that I take pride in being your Mother.  I feel blessed and I am very thankful that God chose you to be my child.  My spunky, fun loving daughter!  I love you with every inch of my heart and with all that is in me.  You are blessed beyond measure and will succeed in all that you do and all that you dream of becoming.  You make being a mother fun and rewarding.  I love you.

Love,

Mom

(Misty Green, Billing Department)

Dear R & S,

I’ve loved you more than air since the day you were born.  I will never stop.  I will always hold you.  I will always be on your side.  I will always have my arms open and ears ready to listen.   If you need help, it can be me.  If you need love, it can be me.  If you need nothing, just company, it can still be me.  I’m so proud of you both.  You have hearts full of love and giggles full of joy.  I pray you will always live by the golden rule.  If you will simply love God, love people and serve others, then you have accomplished more than most.

All of my love,

Momma

(Tanya Bolton, Marketing Director)

Act of Kindness Challenge!

 Lets countdown to Christmas by doing acts of kindness for others this season! I’ve come up with some suggested acts that promise to bring a smile to anyone’s face. I have only included items that are FREE so no one has an excuse! Beginning December 14th lets do “good deeds” each day. If you are unable to do that particular suggestion that day, simply choose another one on the list. I’m willing to bet that you will receive much more joy and Christmas spirit by giving with your heart instead of your wallet!

 

Day 1- Smile at everyone you see today.  A huge toothy smile that makes them wonder what has happened to you!  Smiling is contagious!  The amount of joy you can spread by actively trying to smile today could change many people’s day.

Day 2- Make someone’s shopping trip less stressful.  If you are healthy and able leave the closer parking spaces for someone else.  Another way to bring a smile to their face would be to share you coupons.  If you’re at the mall and have an extra $$ coupon then pass it on to the person behind you in line. I love it when people do this to me!

Day 3-Write a note.  Sit down for 2 minutes and write a hand written note or email to someone who has helped you recently.  It could be a store employee, doctor, teacher, babysitter, etc.  Let them know that you appreciate them and how they brightened your day.  You can also copy to their supervisor so that they may receive recognition.

Day 4-Do not complain about ANYTHING today.  Your mind effects what your mouth says and your mouth effects how your mind feels.  Today we are only spreading positive energy!

Day 5-Use the gift of gab.  Call a relative or friend who lives alone or doesn’t get out much.  Tell them you were just thinking about them and wanted to wish them a Merry Christmas!  You could be the only person they speak to today.

Day 6-Tell an employee that helps you “Thank you.  You are really good at your job!”  This can be anyone who helps you today.  A thank you goes a long way this time of year.

Day 7- Tell an elderly person that they look beautiful, carry their packages to their car or simply say I hope you have a Merry Christmas.  Sometimes our most cherished members of society are overlooked and lonely.

Day 8- Tell your spouse, significant other or best friend how much you care about them.  Let them know that your life is better because of them.  If that person is away you can send an email or leave a voice mail but it’s always better in person.

Day 9-Make someone’s trip to the grocery better! If you have coupons you’re not using leave them laying on top of that item.  When the next guest comes along they will find a little treat.  If you’re not a coupon cutter then simply offer to help someone out to their car.  If you see a Mother with a small child, get her a cart (one with a car attached is preferable!) If none of these opportunities arise simply say Merry Christmas to everyone you make eye contact with!

Day 10- Bite your tongue today.  No matter how busy or frustrated you are today be nice.  If you have nothing nice to say simply smile and reply, “Have a blessed day”.  If someone has been hateful to you that will make them feel like they are about 1 inch tall.  It may help out the next person they come in contact with too!

Christmas Eve- Relax, spend time with your family and think about all of the lives you have affected by spreading random acts of kindness.  This is truly what Christmas spirit should be about!

 

Tanya

A little about myself…

Hi I’m Tanya Bolton. I am 36, married to a good guy and have 2 adorable little girls. I work full time (and then some) at Lexington Women’s Health, have a booth at the local peddlers’ mall, help out in Sunday school, cook dinner every night (sometimes it’s fish sticks) and still find time to take snacks to my daughter’s soccer games. I guess I should start out by telling you about myself…  I am originally from a small town, Barbourville, Kentucky.  When I was 18, I moved to Lexington (the big city) to go to college and it was there that my journey began.  My room-mate who was in PA school, hooked me up with a job at a local obgyn practice answering the switch board.  I loved it.  I loved the people, I loved the doctors, I loved feeling like a grown up in a big office.  I loved it so much, I never left.  I have evolved over the years and so has the practice.  In 2007, we opened the brand new practice “Lexington Women’s Health”.  We are an all female practice that has physicians, midwives, nurse practicioners and physician assistants…Not to mention a fabulous staff. I am now one of the managers and I still love my job!  I joke that if I won the lottery I would just volunteer everyday (or at least 3 days a week)…

Lexington Women’s Health is a great place to work because our motto is that we want everyone to be taken care of like you would want your mother, sister or best friend treated. Over the years, many patients have become our friends. When you have such an intimate relationship over the course of a pregnancy, miscarriage, infertility crisis, divorce, surgery, etc you really get to know each other.  I have gone through many of these things myself at LWH as well and the patients have shared my experiences. It is a very busy and lucrative practice but at the heart of it all (Dr’s Fuson and Cunningham) are the same people I came to love when they first started practicing. They are the 2 partners who founded and continue to manage Lexington Women’s Health.  Daily, I see some of the most miraculous events and also some of the most hilarious. We are truly a family-but working together with over 40 women is not always easy. I have always said, “One of these days I’m going to write a book” but for now, I’ll try a blog.  Through the course of this blog, I hope to have many guest bloggers, aka our providers, to talk about things that most people don’t talk about! Also current health news and issues as well as the craziness that comes along with working together with 40 women! I hope you enjoy reading as much as I enjoy sharing.