The Pitch: "Bioidenticals are safer because they’re custom-made just for you."
Many bioidenticals are compounded by pharmacists who blend various ingredients in specific amounts to create just-for-you medications. A compounding pharmacist may also create alternative delivery systems (a cream or lozenge, for instance) to commercial ones. However, some so-called bioidentical hormones are already available in commercial products, including those delivered through a skin patch or gel. Mainstream doctors prescribe these all the time (some common brands include Estrace, Climara, and Prometrium) but won’t claim that they have any special powers and may not emphasize that they are bioidentical.
Unlike commercially available products, compounded formulas are not regulated by the FDA. "With an FDA-approved hormone, you know that it has been produced in an FDA-approved facility. And if a drug company gets FDA approval for a drug in capsule form, it has to go through the approval process again before selling the same ingredient in a cream or another form," says Larry Sasich, assistant professor of pharmacy at the Lake Erie College of Medicine, in Pennsylvania. "In many compounded products, we don’t know the source of the hormones or how well they work in the form provided. What consumers may be dealing with is a shadow drug industry, one that produces untested products."
The Bottom Line: Sometimes there’s a good reason for compounding: You need a lower dose of testosterone than the one contained in the formula approved for men; you’re allergic to the peanut-oil base in a particular product; your doctor wants you to use a lozenge. However, with a compounded formula, there’s very little quality assurance — you can’t be sure you’re getting the right dose, and you can’t know how much of the hormone will enter your bloodstream from the compounded cream, lozenge, gel, or capsule.
"The idea of being able to give a woman just the right dose and exactly what she needs is so appealing — it just sounds right — but in reality we’re not there yet," Col says. Also fueling the kinder, gentler image of bioidenticals: According to FDA requirements, all estrogen-containing prescriptions are supposed to carry warning labels. Because compounded products are not FDA-regulated, however, they may not include any information about risks or side effects.
Bioidenticals: More Facts and Fictions
The Pitch: "Bioidenticals supplement your natural hormones."
Hearing words such as supplement, augment, and rebalance can lull you into thinking that bioidenticals aren’t really drugs at all. "I use unconventional but natural approaches, like natural hormones. I try to get people off drugs instead of putting them on," says allergist Steven Hotze, MD, author of Hormones, Health, and Happiness: A Natural Medical Formula for Rediscovering Youth.
That kind of talk really irks Bruce Bouts, MD, an internist and pharmacist in Findlay, Ohio. "Promoters of bioidenticals make it sound as if taking estrogen, progesterone, or testosterone is a little like taking a vitamin," he says. "They say, ‘We’re not doing anything mediciney; we’re giving you a supplement to restore your natural hormone balance!’"
The Bottom Line: No matter how they’re described, bioidenticals are biologically active agents. In fact, they require a prescription because they affect the function or structure of the body, which is part of the legal definition of a drug.
If you’re a consumer of compounded hormones, your doctor may be left out of the prescribing loop altogether. While most pharmacists respond solely to prescriptions generated by physicians, many compounding pharmacists reach out to women directly through in-store seminars and menopause consultations designed to get them enthused about bioidenticals. I signed up for a $60 consultation with the pharmacist who owns a local compounding pharmacy. I thought she’d want to hear all about my symptoms and medical history. Within minutes, knowing nothing other than that I have occasional periods and some hot flashes, she suggested a specific mixture of estriol, estradiol, progesterone, and testosterone for me.