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Getting the Facts About Compounded Hormones

Compounded Hormones

"Bioidentical hormone therapy" is often used to describe therapy that contains estrogen, progesterone, or other hormones that are chemically exact duplicates of hormones produced by women, primarily in the ovaries.1,2 Many of these bioidentical hormones (e.g., estradiol, progesterone) are commercially available in several well-tested, FDA-approved, brand-name prescription drugs.1,2

Concern arises with the bioidentical hormone medications that are "custom-compounded" or custom-mixed recipes prepared by a pharmacist following a specific prescription order for a specific patient.1,2 While these compounded hormones may serve useful in some patients, it is also important to consider some of the issues:

  • Compounded hormones don't go through the FDA approval process so there is a lack of FDA reviewed scientific evidence to support their claims of safety and efficacy3
  • It has not been demonstrated that the amount of estrogen contained within these compounds is consistent from dose to dose4
  • Safety information is not consistently provided to patients along with their prescriptions4

In 2001, the US Food and Drug Administration (FDA) analyzed a variety of 29 product samples from 12 compounding pharmacies:2

  • 34% of them failed one or more standard quality tests2
  • 9 of the 10 failing products failed assay or potency tests, with all containing less of the active ingredient than expected2

The testing failure rate for FDA-approved drug therapies is less than 2%.2 The FDA does not regulate compounding pharmacies and does not approve compounded products.

Consider the evidence for estrogen therapy that has been regulated and approved by the FDA. Consider Elestrin—an FDA-approved estrogen therapy indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.5

To learn more about the differences between FDA-approved therapies and compounded hormones, visit the FDA website.

Proven Efficacy of Elestrin

Elestrin has proven efficacy in a randomized, placebo-controlled trial in women experiencing a weekly average of 93 hot flushes.5,6 In fact, a statistically significant reduction (versus placebo) in the frequency of hot flushes was demonstrated at week 3 (P<.01) with the 2-pump (1.7 g/day) dose.6 By the end of the study, there was a 76% reduction in hot flushes with the 2-pump (1.7 g/day) dose.5 With the 1-pump (0.87 g/day) dose there was significant reduction in the frequency of hot flushes at week 5. (P<.01)4

Help Your Patients Save with Elestrin

Many custom compounded therapies are considered experimental and may not be covered by your patients insurance.7 With Elestrin you can access this coupon and your patients will pay no more than $25 on each prescription.

Download and Print the Elestrin Coupon for Your Patients

For more information about Elestrin, please see full Prescribing Information, including Boxed Warning.

Indication

Elestrin is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia. The use of estrogens and progestins has shown an increased risk of breast cancer, myocardial infarction, and pulmonary embolism. The use of estrogen, with or without progestins, has shown an increased risk of stroke, dementia, and DVT while estrogen alone therapy increases the risk of endometrial cancer. The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.

Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.

CARDIOVASCULAR AND OTHER RISKS Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day relative to placebo.

The estrogen plus progestin WHI substudy reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of conjugated equine estrogens with medroxyprogesterone acetate and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, 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. NAMS Web site pdf. http://www.menopause.org/bioidentical.aspx Accessed October 4, 2010.
  2. ACOG, FDA, NAMS Statement pdf.
  3. Cruzan S. Transcript of FDA Press Conference on FDA Actions on Bio-Identical Hormones. January 9, 2008.
  4. 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.
  5. Elestrin (estradiol gel) full Prescribing Information. Azur Pharma, Philadelphia, PA, July 2010.
  6. Simon JA, Bouchard C, Waldbaum A, et al. Low dose of transdermal estradiol gel for the treatment of symptomatic postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007;109:588-596.
  7. 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.