What are the risks and prescribing details of non-FDA (Food and Drug Administration) approved bioidentical hormone therapies?

Non-FDA Approved Bioidentical Hormone Therapy: Risks and Prescribing Details

Non-FDA approved bioidentical hormone therapies lack scientific evidence for safety and efficacy and should not be prescribed when FDA-approved alternatives exist due to significant risks to patient morbidity and mortality. 1

What Are Bioidentical Hormones?

Bioidentical hormones have the exact same chemical and molecular structure as hormones produced in the human body 2. While there are FDA-approved bioidentical hormone formulations available, this discussion focuses on non-FDA approved compounded versions.

Non-FDA Approved Bioidentical Hormone Products

Common Components

• Estriol (not FDA approved in the US)
• Estrone
• Estradiol (available in FDA-approved formulations)
• Testosterone
• Micronized progesterone (available in FDA-approved formulations)
• Dehydroepiandrosterone (DHEA)

Key Concerns with Non-FDA Approved Products

1. Lack of Standardization: Content and quality are uncertain in compounded preparations 2
2. No Regulatory Oversight: Safety and effectiveness have not been evaluated through FDA's drug approval process 3
3. Absence of Clinical Trial Data: No randomized trials have studied potential benefits or harms for prevention of chronic conditions 3
4. Misleading Marketing: "Bioidentical hormone replacement therapy" is a marketing term rather than a formally defined drug classification 3

Safety and Efficacy Concerns

The U.S. Preventive Services Task Force (USPSTF) found no randomized trials that have studied the potential benefits or harms of bioidentical hormones for the prevention of chronic conditions in postmenopausal women 3. This lack of evidence is particularly concerning given the known risks associated with hormone therapy in general:

• Increased risk of stroke
• Venous thrombosis
• Potential breast cancer risk
• Cardiovascular complications

Current Medical Organization Positions

Multiple medical organizations have taken positions against non-FDA approved bioidentical hormone therapy:

• American College of Obstetricians and Gynecologists (ACOG) recommends against routine prescription of compounded bioidentical menopausal hormone therapy when FDA-approved formulations exist 1
• Most medical organizations have refuted bioidentical hormone therapy claims as unsubstantiated 4

Problematic Prescribing Practices

Many advocates of compounded bioidentical hormones:

• Customize prescriptions based on saliva tests or blood sera levels
• This practice directly contradicts evidence-based guidelines 5
• Make unsubstantiated claims of being "natural" and "safer" than conventional hormone therapies 5

FDA-Approved Alternatives

For those requiring hormone therapy, FDA-approved bioidentical options include:

• Estradiol (FDA approved for menopausal symptoms)
• Estropipate (FDA approved for menopausal symptoms)
• Progesterone (FDA approved for menopausal symptoms and prevention of endometrial hyperplasia) 6

Recommendation Algorithm for Clinicians

1. First-line approach: Use FDA-approved hormone therapy formulations when hormone therapy is indicated
2. Patient education: Explain the lack of safety and efficacy data for compounded bioidentical hormones
3. Risk assessment: If a patient insists on compounded bioidentical hormones, document a thorough discussion of the unknown risks
4. Monitoring: Implement more frequent follow-up for patients choosing compounded products due to unknown risks

Key Pitfalls to Avoid

1. Salivary hormone testing: This is not standardized and should be avoided 6
2. Accepting marketing claims: Claims of "natural" or "safer" products are not supported by evidence
3. Assuming equivalence: Do not assume compounded products have the same safety profile as FDA-approved formulations
4. Overlooking FDA-approved bioidentical options: Many patients don't realize that FDA-approved bioidentical hormones exist

In conclusion, clinicians should strongly discourage the use of non-FDA approved compounded bioidentical hormone therapy due to lack of scientific evidence supporting safety and efficacy 1. When hormone therapy is indicated, FDA-approved formulations (including FDA-approved bioidentical hormones) should be used to minimize risks to patient health.