SIGN THE PETITION in Support of NAMS Proposal for a Label Change On the Boxed Warning for Lower-Dose Vaginal Estrogen

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Attention all vagina owners!

On November 10, 2015, the US Food and Drug Administration (FDA) is holding a workshop in Silver Spring, Maryland on the subject of the product labeling of lower-dose vaginal estrogen.  This workshop will also provide public comments and testimonials on this subject.

I am happy to hear that The North American Menopause Society (NAMS) is spearheading the need for the box labeling for low dose vaginal estrogen to be changed.  Right now the box labeling overstates the potential risks, and frankly it inhibits many doctors from prescribing this treatment. When women read the box label they are scared half to death to use this very successful treatment option.

Lower dose vaginal estrogen, commonly referred to as LET (local estrogen therapy) is used for women who are experiencing the following symptoms:

  • Vaginal dryness
  • Vaginal burning
  • Vaginal discharge
  • Genital itching
  • Burning with urination
  • Urgency with urination
  • More urinary tract infections
  • Urinary incontinence
  • Light bleeding after intercourse
  • Discomfort with intercourse
  • Decreased vaginal lubrication during sexual activity
  • Shortening and tightening of the vaginal canal

The medical community has many names for this condition: dyspareunia, vulvar and vaginal atrophy or Genitourinary (Don’t worry, I can’t pronounce that either.) Syndrome of Menopause.  For our purposes, let’s call it dry vagina!

Dry vagina occurs when there’s a drop in levels of estrogens, produced by the ovaries. Estrogens maintain the structure and function of the vaginal wall, the elasticity of the tissues around the vagina, and production of vaginal fluid. When it comes to the vagina, thin is out!

As if graying hair, sagging tatas and expanding waists weren’t enough, we now find out that our vaginas are aging too! If you feel you’re left high and dry, you’re not alone. Vaginal dryness affects as many as 75 percent of postmenopausal women. Between 17 and 45 percent of postmenopausal women say they find sex painful, according to The North American Menopause Society (NAMS).

It is important to understand that dry vagina is a progressive condition that adversely affects the health and quality of life for many postmenopausal women.

LET is estrogen applied directly to vaginal tissues, so it goes directly to the affected area, with minimal absorption of estrogen into the bloodstream. LET is available in creams, a ring (this one is not diamond encrusted) and a tablet.

According to NAMS, low-dose vaginal estrogen is very effective against atrophy-related pain during sex, with up to 93% of women reporting significant improvement and 57% to 75% reporting that their sexual comfort is restored. Improvements in vaginal moisture and health typically occur within a few weeks of starting therapy, although relief from severe vaginal atrophy can take several months.

Here is how you can support this effort:

Detailed information about this workshop is provided here. The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Conference Center, Section A of the Great Room (Room 1503), Silver Spring, Maryland, 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1.

Citizens’ Petition

NAMS has published a commentary in the September 2014 issue of Menopause to encourage modifications to the product labeling of low-dose vaginal estrogen (Manson JE, Goldstein SR, Kagan R, et al. Why the product labeling for low-dose vaginal estrogen should be changed. Menopause. 2014;21:911-916). If you would like to indicate your support for this proposal, please sign the Citizens’ Petition here. Deadline for signatures is November 10th!

It’s been about 10 years since my vagina was found stranded on a desert island and took my sex drive with it! Since rescuing it, my life is full, happy and satisfied. Remember: Your symptoms are treatable. You can have a happy vagina again!

Please share with the sisterhood!

My Motto: Suffering in silence is OUT! Reaching out is IN!

Click here to download my free eBook, MENOPAUSE MONDAYS The Girlfriend’s Guide To Surviving and Thriving During Perimenopause and Menopause.

After struggling with her own severe menopause symptoms and doing years of research, Ellen resolved to share what she learned from experts and her own trial and error. Her goal was to replace the confusion, embarrassment, and symptoms millions of women go through–before, during, and after menopause–with the medically sound solutions she discovered. Her passion to become a “sister” and confidant to all women fueled Ellen’s first book, Shmirshky: the pursuit of hormone happiness. As a result of the overwhelming response from her burgeoning audiences and followers’ requests for empowering information they could trust, Ellen’s weekly blog, Menopause MondaysTM, was born.

  • Generation Above Me

    Thanks for keeping an eye on this and other menopause-related issues. You are a good advocate for menopause health.

    • The deadline to sign the petition is November 10th. Please help me spread the word. Thanks for your sweet support!

  • Carol Graham

    As a health coach who has helped women in all stages of their health, it is a shame that more information isn’t promoted to make women aware that there are natural methods to curb and eliminate all those nasty symptoms – without the use of drugs.

    • I agree. I have written many blogs on vaginal atrophy where I discuss the various non-hormonal options available. I want women to understand all of their options. LET is one of them. But as a point of information, what would you recommend to a woman who has tried all the non-hormonal options, but she still has seriously painful vaginal atrophy causing shortening and tightening of the vaginal canal, pain, burning etc?

      • Carol Graham

        I rarely suggest anything without doing a full analysis. As a symptomologist I “read” symptoms to paint the picture of what the deficiency is — it is rarely one thing. But, the short answer is, most women with these symptoms are deficient in the amino acids – but the products must be in the proper balance. If you have anyone whom you would like to help, they can PM me and I will see what I can offer to bring them relief.

        • I am always open to new ways to help women through the myriad of often life-changing symptoms of menopause. Looking at amino acid deficiency is definitely a new approach for me. Thanks for sharing!

  • i really appreciate your keeping us on the cutting edge of things happening that relate to women’s health I’ll share this.

  • Lois Alter Mark

    Going to sign right now. Thank you so much for raising awareness of these important issues and keeping us up to date. What would we do without you?!

    • Thank, Lois! I just love the sisterhood…when we band together we are def a force to be reckoned with!

  • Haha! You are right…better late than never! The NAMS is actively working on having the boxed warning on prescription vaginal estrogen changed to a more appropriate warning. Experts from NAMS met with the US Food and Drug Administration in November 2015 and presented data on the safety of low-dose vaginal estrogen and reasons why the label should be changed and why changing the label would be in the patient’s best interest. We’ll see what they do! Stay tuned!

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