Are FDA Approved Bioidentical Hormones Really Bioidentical?
It does seem like an oxymoron to have the words “bioidentical” and “FDA approved” in the same sentence, I know. If you’re like me, you’ve probably always associated anything that is FDA approved with pharmaceutical companies. You’ve probably also thought that anything produced by a pharmaceutical company couldn’t be bioidentical or natural either – and you would be mostly right, but not entirely.
Feeling confused; skeptical; cautious? Welcome to my world.
My own journey through perimenopause began in 1998. Bioidentical hormones were still making their entrance into mainstream thought back then, and the Women’s Health Initiative study had not yet been released. Though I didn’t know much about perimenopause and menopause, I did know that hormone replacement therapy was something that some women chose to take to help them with their symptoms.
By the time my own symptoms were at their worst, it was 2003, the Women’s Health Initiative study had been released, and everybody was talking about natural alternatives to synthetic hormone replacement therapy. Thus began my own foray into trying to understand this confusing world of hormones.
Unfortunately for me, by the time I began to really understand the difference between synthetic hormones and bioidentical hormones, I was close to actual menopause, and hormone replacement therapy seemed like a moot point. However, I did feel certain about one thing: I believed anything that came from a pharmaceutical company was not to be trusted.
I’ve evolved since then, and have come to realize that the only truly natural hormone is that which is produced by your body. Everything else has to be replicated in a laboratory – even bioidentical hormones.
In my last post, I told you that I have recently begun to take Prometrium, an FDA approved, bioidentical progesterone. I am taking it to help me sleep and to help with the hot flashes and night sweats that I continue to experience in menopause.
Prometrium is considered natural rather than synthetic because the chemicals which are used to pharmaceutically produce it are derived from yams. It is considered bioidentical because the chemical structure (the molecules) is “identical” to the hormones which your body naturally produces. Therefore, Prometrium, is a bioidentical, naturally derived, FDA approved hormone produced by a pharmaceutical company.
Is it safe? As safe as any other FDA approved prescription. However, if something is FDA approved it does not mean that it is 100% safe for 100% of people who choose to take it. It simply means that it is “sufficiently safe” and has been clinically proven to be more helpful than harmful.
Are there risks associated with Prometrium? Yes. There are risks associated with any drug, prescription, supplement, or chemical you choose to put in your body. Should you take Prometrium because it is FDA approved and other bioidentical hormones are not? That is a personal choice.
I have used some excellent bioidentical progesterone which was compounded in a compounding pharmacy, but which was not FDA approved. There are some good products out there. However, in order to find them, you have to do your homework. Unfortunately, not all bioidentical progesterone products are quality products.
I chose to try Prometrium based on the research I had done, because it is FDA approved, and also because I knew my insurance company would pay for it. If you are interested in trying it, I would recommend that you do your own research before you make your decision.
But if you have heard of Prometrium and have wondered if it is truly bioidentical, you can rest assured that it is.
Magnolia Miller is a certified healthcare consumer advocate in women’s health and a women’s freelance health writer and blogger at The Perimenopause Blog.