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Food and Drug Administation warnings

 Errors in  “menopause” treatment

The menopause disease (The androgenic disease of menopause)

In any case please read the recommendations of the Food and Drug Administration. pdf.

In any case please read the recommendations of the Food and Drug Administration. pdf.

Booklet from FDA about HRT

Office of Women's Health

Medicines to Help You

Menopause

Some women choose to treat their menopause symptoms with hormone medicines. This booklet lists some basic information about the FDA-approved hormone medicines for menopause. Use this booklet to help you talk to your healthcare provider about whether hormone medicines are right for you.

Learn more about menopause at: www.fda.gov/menopause

Menopause (sometimes called "the change of life") is a normal time in a woman's life when her period stops. During menopause, a woman's body makes less of the hormones estrogen and progesterone. Lower hormone levels may lead to symptoms like night sweats, hot flashes, and vaginal dryness along with thin bones.

Some women choose to treat their menopause symptoms with hormone medicines sometimes called Hormone Therapy. There are different types of hormone medicines used during and after menopause:

·         Estrogen-Only Medicines

·         Progestin-Only Medicines

·         Combination Estrogen and Progestin Medicines

·         Combination Estrogen and Other Medicines

This booklet does not talk about non-hormone medicines for menopause. Ask your healthcare provider about the FDA-approved non-hormone medicine for menopause called Brisdelle (paroxetine).

 

Do not take hormone therapy if you:

·         have problems with vaginal bleeding

·         have or have had certain cancers such as breast cancer or uterine cancer

·         have or have had a blood clot, stroke or heart attack

·         have a bleeding disorder

·         have liver disease

·         have allergic reactions to hormone medicine

Side Effects

Hormone medicines can have side effects. Serious health problems can happen in women who take menopause hormone therapy.

-   For some women, hormone medicines may raise their chances of blood clots, heart attacks, strokes and breast cancer.

- For some women who are 65 years old or older, hormone medicines may raise their chances of dementia.

- For women who still have their uterus, taking estrogen-only medicines raises their chance of getting cancer of the lining of the uterus or endometrial cancer. These women need to take progestin to prevent endometrial cancer.

This booklet does not list all of the side effects and warnings for each hormone medicine. Ask your healthcare provider about all of the benefits and risks of taking hormone medicines. Also check the FDA website to learn more about each medicine listed in this booklet. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

In any case please read the recommendations of the Food and Drug Administration. download pdf.

 

   Estrogen-Only Medicine    

Do not use if you:

·        have unusual vaginal bleeding

·        have or have had certain cancers such as breast cancer or uterine cancer

·        have or have had blood clots in the legs or lungs

·        have a bleeding disorder

·        have had a stroke or heart attack

·        have liver problems

·        have serious reactions to estrogen medicines

·        think you are pregnant

   Estrogen-Only Medicine    

 

Brand Name

Generic Name

Product Type

Alora

Estradiol

Patch

Cenestin

Synthetic Conjugated Estrogens

Pill

Climara

Estradiol

Patch

Delestrogen

Estradiol Valerate

Injection (Shot)

Divigel

Estradiol

Gel

Elestrin

Estradiol

Gel

Enjuvia

Synthetic Conjugated Estrogens

Pill

Esclim

Estradiol

Patch

Estrace

Estradiol

Pill, Vaginal Cream

Estraderm

Estradiol

Patch

Estrasorb

Estradiol

Skin Cream (Emulsion)

Estring

Estradiol

Vaginal Insert

EstroGel

Estradiol

Gel

Evamist

Estradiol

Skin Spray (Transdermal)

Femring

Estradiol Acetate

Vaginal Ring

 Femtrace

Estradiol Acetate

 

Pill

 

Menest

Esterified Estrogen

Pill

Menostar (only used to prevent osteoporosis)

Estradiol

Patch

Minivelle

Estradiol

Patch

Ogen

Estropipate

Pill, Vaginal Cream

Ortho-Est

Estropipate

Pill

Osphena (not estrogen only)

Ospemifene

Pill

Premarin

Conjugated Estrogens

Pill, Vaginal Cream, Injection (Shot)

Vagifem

Estradiol

Vaginal Tablet

Vivelle

Estradiol

Patch

Vivelle-Dot

Estradiol

Patch

 

   Estrogen-Only Medicine    

Less Serious, Common Side Effects

·      Headaches

·      Painful or tender breasts

·      Vaginal spotting

·      Stomach cramps/bloating

·      Nausea and vomiting

·      Hair loss

·      Fluid retention

·      Vaginal yeast infection

Serious Side Effects

·      Stroke or blood clots

·      Endometrial cancer in women who stil) have their uterus and who do not use progestin with estrogen-only medicines

  • Dementia in women 65 years and older

  • Gallbladder disease or high triglyceride (cholesterol) levels that could lead to problems with your pancreas

  • Vision loss caused by a blood clot in the eye

·      Liver problems

·      High blood pressure

·      Severe allergic reactions

For more information about the risks and side effects for each drug, check Drugs@FDA:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

 

   Progestin-Only Medicines   s    

Estrogen-Only medicines are usually taken with Progestin-Only medicines to lower the chance of getting endometrial cancer in women who still have their uterus.

The side effects listed below are for women who take a Progestin-Only medicine and an Estrogen-Only medicine

Progestin-Only Medicines   s

Brand Name

Generic Name

Product Type

Prometrium

Micronized
Progesterone

Pill

Provera

Medroxyprogesterone Acetate

Pill

Do not use if you:

·       have unusual vaginal bleeding

·       have or have had certain cancers such as breast cancer or uterine cancer

·       have or have had blood clots in the legs or lungs

·       have a bleeding disorder

·       have had a stroke or heart attack

·       have liver problems

·       have serious reactions to estrogen medicines

·       think you are pregnant

Serious Side Effects

·       Heart attack or stroke

·       Blood clots

·       Breast cancer

·       Dementia in women 65 years and older

Gallbladder disease or high triglyceride (cholesterol) levels that could lead to problems with your pancreas

·       Liver problems

·       Vision loss caused by a blood clot in the eye

·       High blood pressure

·       Severe allergic reactions

Less Serious, Common Side Effects

·       Headaches

·       Painful or tender breasts

·       Vaginal spotting

·       Stomach cramps/bloating

·       Nausea and vomiting

·       Hair loss

·       Fluid retention

·       Vaginal yeast infection

For more information about the risks and side effects for each drug, check Drugs@FDA:

http://www.accessdata.fda.goviscriptecder/drugsatfdeindex.cfm

 

   Combination Estrogen and Progestin Medicines        

Do not use if you:

·      have unusual vaginal bleeding

·      have or have had certain cancers such as breast cancer or uterine cancer

·      have or have had blood clots in the legs or lungs

·      have a bleeding disorder

·      have had a stroke or heart attack

·      have liver problems

·      have serious reactions to estrogen medicines

·      think you are pregnant


   Combination Estrogen and Progestin Medicines   s

Brand Name

Generic Name

Product Type

Activella

Estradiol/Norethindrone Acetate

Pill

Angeliq

Estradiol/Drospirenone

Pill

Climara Pro

Estradiol/
Levonrgestrel

Patch

Combipatch

Estradiol/Norethindrone Acetate

Patch

Femhrt

Norethindrone Acetate/ Ethinyl Estradiol

Pill

Prefest

Norethindrone Acetate/ Ethinyl Estradiol

Pill

Prempro

Conjugated Estrogen/
Medroxyprogesterone

Pill

Serious Side Effects

·      Heart attack or stroke

·      Blood clots

·      Breast cancer

·      Dementia in women 65 years and older

·      Gallbladder disease or high triglyceride (cholesterol) levels that could lead to problems with your pancreas

·      Vision loss caused by a blood clot in the eye

·      Liver problems

·      High blood pressure

·      Severe allergic reactions

Less Serious, Common Side Effects

  •    Headaches

·      Painful or tender breasts

·      Vaginal spotting

·      Stomach cramps/bloating

·      Nausea and vomiting

·      Hair loss

·      Fluid retention

·      Vaginal yeast infection

 

For more information about the risks and side effects for each drug, check Drugs@FDA:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

 

           Combination Estrogens and Other Medicines       

Brand Name

Generic Name

Product Type

Duavee

Conjugated Estrogen/ Bazedoxifene

Pill

You should not use Duavee if you are taking medicines that have estrogen, progestin or both hormones.

Do not use if you:

·       have unusual vaginal bleeding

·       have or have had certain cancers such as breast cancer or uterine cancer

·       have or have had blood clots in the legs or lungs

·       have a bleeding disorder

·       have had a stroke or heart attack

·       have liver problems

·       have had a serious allergic reaction to estrogen medicines

·       think you are pregnant or may become pregnant
are breastfeeding (nursing)

 

Serious Side Effects

·         Stroke or blood clots

·         Dementia in women 65 years and older

·         Gallbladder disease or high triglyceride (cholesterol) levels that could lead to problems with your pancreas

·         Vision loss caused by a blood clot in the eye

·         Liver problems

·         High blood pressure

·         Severe allergic reaction

 

Less Serious, Common Side Effects

·      Muscle spasms

·      Nausea

·      Diarrhea

·      Upset stomach/stomach pain

·      Throat pain

·      Dizziness

·      Neck Pain

For more information about the risks and side effects for each drug, check Drugs@FDA:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

In any case please read the recommendations of the Food and Drug Administration. download pdf.

Learn more about menopause:www.fda.gov/menopause


Office of Women's Health

www.fda.gov/womens

 

This booklet was developed by the U.S. Food and Drug Administration (FDA) Office of Women's Health. To download free copies of this booklet and other materials visit: www.fda.gov/womenshealthpubs

2013

 

G. Debled. The menopause disease. Approaches to aging control : 19:17-24,October 2015

The menopause disease .pdf  Octobre 2015.    SEMAL Madrid

The androgenic disease of menopause