Bioidenti what?

Posted by Liz on Jun 13, 2008 in women's health | 0 comments

Bioidentical hormones (also known in many circles as “compounded biodentical hormones”) are compounds that have exactly the same chemical and molecular structure as hormones produced in the human body. The term is most often used in the context of estrogen and progesterone (and androgens), although any hormone can be made this way. Notably, there are a few of these agents that are actually FDA-regulated and available from retail and not compounding pharmacies (meaning that dosage and purity are theoretically on par with synthetic types).

There’s been a lot of hullaballoo over these products from many of the major associations that are involved in women’s health (e.g. The Endocrine Society, North American Menopause Society) primarily because: 1) they are not regulated by the FDA or have any oversight whatsoever and 2) potency is inconsistent. In fact, the FDA sent warning letters to nine pharmacies in January due to what the agency felt were unsupported claims about safety and effectiveness.

FDA does not just randomly go after pharmacists who practice traditional compounding and who don’t make false claims about their products. Traditional compounding, in fact, involves the preparation of a drug for a specific patient based on a doctor’s request.

Consequently, FDA action might have been driven, in party, by Wyeth Pharmaceuticals, who filed a Citizens Petition that claimed: 1 that compounding pharmacies were not actually compounding but “manufacturing” mimics of approved agents; 2) that they used a form of estrogen known as “estradiol” not commonly found in “traditional” hormone therapies; 3) that they were engaging in illegal promotional practices. (BTW, Wyeth manufactures several estrogen products, including Premarin, Prempro, and Premphase.) You can read the rest of the petition here.

It’s important to recognize that not all compounded products are bad. In fact, compounding pharmacies continue to provide options to patients with contraindications to commercially-produced therapies. An article in a large monograph sponsored by the North American Menopause Society explains that pharmacies were compounding micronized progesterone years before an agent (Prometrium) was approved in the US. It also goes on to highlight several advantages that compounded hormones might offer over conventional products, including greater dosing flexibility, lower doses for women who are especially sensitive and the avoidance of potential allergens.

Organizations such as the International Academy of Compounding Pharmacists (IACP) have become quite outspoken about what they consider to be the FDA’s interference in physician decisions to prescribe estriol to their patients. Congress has even introduced a bipartisan-sponsored bill (Resolution 342) to reverse the FDA’s decision on estriol. There’s a website that further explains these efforts.

In the meantime, if you decide you want to try bioidentical hormones, speak to your health practitioner. S/he can devise a regimen that best meets your needs (and not the needs of the masses) and may be able to recommend a credible compounding pharmacy. The IACP might also be able to assist with your search.