Myth or menopause?

Test your knowledge about menopause by reading through these common myths.
Myth or menopause?
Test your knowledge about menopause by reading through these common myths.

Myth: Hormone therapy isn’t safe.

Hormone therapies that are FDA-approved have been clinically tested for safety and have been demonstrated to work. However, as with all drugs, there are benefits and risks to hormone therapy, and these will be different for each person.

All hormone therapies, regardless of form, administration type, and dosage, carry FDA warnings about potential serious risks, including1,8:

Estrogen-alone therapy:

Estrogen-alone therapy:

  • Increases your chance of getting cancer of the uterus (womb)
  • Should not be used to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
  • May increase your chances of getting strokes or blood clots
  • May increase your chance of getting dementia, based on a study of women 65 years of age or older

Estrogens with progestins:

Estrogens with progestins:

  • Should not be used to prevent heart disease, heart attacks, strokes, or dementia
  • May increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • May increase your chance of getting dementia, based on a study of women 65 years of age or older

These warnings are not meant to cause fear or alarm; they are meant to underscore the importance of weighing the benefits and risks of hormone therapy, while considering your individual needs, treatment goals, and personal and family medical history. Together with your healthcare professional, you can decide if hormone therapy is right for you.

Women who think they are pregnant, have problems with vaginal bleeding, have had certain kinds of cancers (including cancer of the breast or the uterus), have had a stroke or heart attack, have had blood clots, or have liver disease should not take hormone therapy.8 In addition, women should not take hormone therapy if they have been diagnosed with a bleeding disorder or are allergic to the ingredients.1

To learn more about the potential risks of hormone therapy, please read the Patient Information leaflet or the Full Prescribing Information including Boxed Warning for Divigel®.

Myth: Alternative treatments for hot flashes work just as well and are safer.

Myth: Alternative treatments for hot flashes work just as well and are safer.

There are many, many alternative treatments for hot flashes on the market, such as supplements or remedies purchased over the counter, claiming to relieve symptoms naturally and safely. Some may be effective in reducing mild hot flashes to some degree. If you do get relief, however, many experts believe it may be due in part to a placebo effect.3

In the United States, supplements are not held to the same FDA regulations and standards that are applied to prescription medications. Only FDA-approved therapies are required to demonstrate effectiveness and safety.

Be aware that supplements may cause side effects, and that they may also negatively interact with other medications you may be taking. Before you decide to use supplements, please speak with your healthcare professional.3

Myth: Estrogen therapy is too expensive to use every month.

Myth: Estrogen therapy is too expensive to use every month.

Divigel® has broad insurance coverage—and with the Divigel® Patient Savings Coupon, you may be eligible to save even more on your prescription. Register for a Divigel® Patient Savings Coupon and we’ll send it to you today!

Myth: There is no difference between FDA-approved estrogen therapy and custom-compounded estrogen therapy.

Myth: There is no difference between FDA-approved estrogen therapy and custom-compounded estrogen therapy.

Although they are both made from estrogen, there are significant differences between custom-compounded therapies and FDA-approved therapies such as Divigel®.

Compounded hormone therapy may be appropriate for some women, particularly those who cannot tolerate commercially manufactured forms.3 However, not all compounded products are supported by rigorous studies to prove they are safe or effective, and there is less oversight for quality, purity, and consistency.3 It is possible that these untested mixtures may even contain unknown contaminants. 

Every woman is unique, so there is no one answer for which kind of treatment is right for you. The bottom line is that before seeking custom-compounded hormones, you should talk with your healthcare professional about your treatment goals, your personal and family medical history, and the potential risks of any and all medications you are currently taking or thinking about taking.

Myth: Everyone goes through menopause, so there’s no need to “treat” its symptoms like a disease.

Myth: Everyone goes through menopause, so there’s no need to “treat” its symptoms like a disease.

Menopause is indeed a natural part of life, and some women experience no symptoms or mild symptoms that do not interfere with their day-to-day activities. However, women who experience moderate to severe hot flashes, which disrupt activities and interrupt sleep, should talk to their healthcare professionals about treating their symptoms with hormone therapy.

Myth: Estrogen therapy is unnatural.

Myth: Estrogen therapy is unnatural.

There are no “natural” estrogen products that are FDA-approved.3 However, some estrogen therapies such as Divigel® contain 17β-estradiol, which is bioidentical to the estrogen produced naturally in a woman’s body prior to menopause.1,3 The estradiol in Divigel® is synthesized from plant sources, such as yams, soy, or sunflowers, and has been demonstrated to provide effective relief of moderate to severe hot flashes, which include night sweats.1,2,4

 

Did any of the myths fool you? Talk to your healthcare professional to find out more, or check out our Resources section.


Important Safety Information & Indication

Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe hot flashes due to menopause.

What is the most important information I should know about Divigel® (an estrogen hormone)?
  • Using estrogen-alone increases your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Divigel®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®

Divigel® should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus, had a stroke or heart attack; currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to Divigel® or any of its ingredients, or think you may be pregnant.

Tell your healthcare provider about all of your medical problems and the medicines you take, if you are going to have surgery or will be on bed rest, and if you are breastfeeding.

Call your healthcare provider right away if you get any of the following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargement of benign uterus tumors (“fibroids”).

Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

Please see Patient Information for Divigel® and talk to your healthcare provider. For more information, call 732-721-0070 or visit www.divigel.com.

You are encouraged to report negative side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784), or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Important Safety Information & Indication
Important Safety Information & Indication

Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe hot flashes due to menopause.

What is the most important information I should know about Divigel® (an estrogen hormone)?
  • Using estrogen-alone increases your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Divigel®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®

Divigel® should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus, had a stroke or heart attack; currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to Divigel® or any of its ingredients, or think you may be pregnant.

Tell your healthcare provider about all of your medical problems and the medicines you take, if you are going to have surgery or will be on bed rest, and if you are breastfeeding.

Call your healthcare provider right away if you get any of the following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargement of benign uterus tumors (“fibroids”).

Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

Please see Patient Information for Divigel® and talk to your healthcare provider. For more information, call 732-721-0070 or visit www.divigel.com.

You are encouraged to report negative side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784), or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.