Elestrin estradiol gel 0.06%

Menopause
and Treatment Options

What Are Bioidenticals? Are There Risks?

Separating Truth From Media Buzz

The term "bioidentical" can be confusing. Bioidentical medications contain hormones that are chemically identical to those produced by the body. Many bioidenticals are well-tested, brand name estrogen products that are approved by the US Food and Drug Administration (FDA) and contain 17 beta-estradiol; estrogen that is identical to that produced by a woman's body.

Often, though, the term bioidentical is used to refer to compounded hormones or mixtures that are created by compounding pharmacists according to a healthcare provider's prescription.1 Recently, different media outlets have been buzzing with advertisements for these compounded hormones. Advertisements for compounding pharmacists claim that through saliva testing of your hormone levels, they can custom-make a drug just for you.

Unfortunately, this media buzz has resulted in misleading claims about compounded bioidenticals being safer, more natural, and even superior to FDA-approved estrogen therapy. So, what's the real story?

This is what the FDA has advised:

  • Compounded bioidenticals are not FDA-reviewed or -approved
    • The FDA has not validated or approved many of these hormone preparations2
    • Many compounded bioidenticals have not undergone the rigorous scientific scrutiny for safety and effectiveness that is required of FDA-approved therapies2
    • There is no substantial credible scientific evidence, which compares the safety and efficacy of compounded hormone therapy versus FDA-approved therapy. Claims for compounded "bioidentical" hormone therapies as being safer or more effective than FDA-approved therapies are not scientifically supported: "FDA is not aware of any credible scientific evidence to support claims made regarding the safety and effectiveness of compounded ‘bioidentical hormone replacement therapy' drugs."2
    • All hormone therapy, including compounded bioidenticals, have risks. There is no substantial data that compounded bioidenticals present less risk of blood clots, heart attack, stroke, breast cancer or gall bladder disease.2
    • Many well-tested, FDA-approved, brand name estrogen products contain estrogen that is identical to that produced in a woman's body and, therefore, considered "bioidentical"
  • There are many inconsistencies to compounded bioidenticals
    • It is not known whether the amount of estrogen given in compounded bioidenticals is consistent from dose to dose2
    • Pharmacies that make bioidenticals may not all follow good manufacturing requirements that apply to commercial drug manufacturers2
    • Safety information is not consistently provided to women along with their prescription1
  • "Custom" mixing is a false promise
    • Saliva testing of hormone levels is unreliable because hormone levels can vary throughout the day2
  • Your insurance may not cover compounded bioidenticals
    • Many custom-compounded therapies are considered experimental and may not be covered by insurance1

All estrogen therapy has risks. Please see important safety information at the bottom of this page.

Indication

Elestrin is indicated for the treatment of moderate-to-severe hot flashes and night sweats associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia (decline in memory or thinking skills). Estrogen and progestin therapy has shown an increased risk of breast cancer, heart attack, and blood clots. Estrogen therapy, with or without progestins, increases the risk of stroke and dementia. Estrogen therapy alone increases the risk of cancer of the uterus (womb).

Elestrin 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 in the recent past; currently have or have had blood clots; currently have or have had liver problems; or think you may be or know that you are pregnant.

The most frequently reported adverse events in clinical trials were nose and throat irritation, breast tenderness, upper respiratory tract infection, and irregular menstrual bleeding.

You and your healthcare provider should discuss whether Elestrin is right for you or whether you still need treatment with Elestrin.

Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.

You are encouraged to report negative side effects of prescription drugs to the FDA (Food and Drug Administration).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-890-3098.

References

  1. North American Menopause Society. Estrogen and progestogen use in postmenopausal women: 2010 position statement of the North American Menopause Society. J North Am Menopause Soc. 2010:17(2):242-255.
  2. US Food and Drug Administration. Bio-Identicals: sorting myths from facts. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm. Accessed July 20, 2010.