Written by Sophie Patel - February 04, 2023
Why Bioidentical Hormones Are Not FDA Approved
As a hormone replacement therapy provider, I get asked this question often: "What is the story behind bioidentical hormones not being FDA approved?" The answer lies in the regulatory process that governs the approval and use of drugs in the United States.
What are Bioidentical Hormones?Bioidentical hormones are hormones that have the same chemical structure as hormones that are naturally produced by the body. They are usually derived from plant sources like yams and soy, and are touted to be safer and more effective than conventional hormone replacement therapies like synthetic estrogen or progesterone.
Regulatory Challenges:One of the reasons bioidentical hormones are not FDA approved is that they are not standardized. Unlike conventional hormone replacement therapy, which has been subjected to rigorous testing by the FDA, bioidentical hormones are formulated on a case-by-case basis by compounding pharmacists. This process is not subject to FDA oversight, and as a result, the quality and safety of these products cannot be guaranteed.
Safety Concerns:Another reason why bioidentical hormones are not FDA approved is that there are safety concerns regarding their use. Despite the claims made by some proponents of bioidentical hormones, there is no evidence that they are any safer than conventional hormone replacement therapy. In fact, some studies have suggested that they may even be more dangerous.
Lack of Scientific Evidence:A big issue with bioidentical hormones is the lack of scientific evidence to support their use. While proponents of bioidentical hormone therapy claim that these hormones are effective in treating a wide range of conditions, including menopause, there is little scientific evidence to support these claims. Today, most health care providers agree that there is insufficient evidence to support the widespread use of bioidentical hormones despite anecdotal evidence.
The Role of Big Pharma:Another factor that contributes to the lack of FDA approval for bioidentical hormones is the role of "big pharma." Synthetic hormones produced by pharmaceutical companies are more rigorously tested and regulated by the FDA, which means that there is a vested interest in promoting these therapies over bioidentical hormones among drug companies.
Where to Find Bioidentical Hormones:Despite the lack of FDA approval, many women want to try bioidentical hormones as an alternative to conventional hormone replacement therapy. For those who are interested in trying bioidentical hormones, it's important to work with a qualified healthcare provider and obtain these hormone compounds from a reputable compounding pharmacy.
ABC Hormones - Your Trusted Hormone Replacement Therapy ProviderIf you are looking for a qualified healthcare provider who can help you navigate the world of bioidentical hormones, look no further than ABC Hormones. Our team of hormone replacement therapy experts will work with you to develop a personalized treatment plan that meets your unique needs and goals. Contact us today to learn more about our services and schedule a consultation.
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