At issue

Last update: November 12, 2005 - 10:00 PM

In mid-October, prescription drugmaker Wyeth called on the Food and Drug Administration to investigate the quality and claims of "custom-mixed" or "custom-compounded" bioidentical hormones used to ease symptoms of menopause. While many bioidenticals are FDA-approved, custom-compounded bioidenticals — tailored to each woman's unique needs and mixed at compounding pharmacies — are not. Bioidentical vs. custom-compounded While the terms often are used interchangeably, they mean different things. Bioidentical hormones are molecularly the same as the estrogen, progesterone and testosterone hormones produced by the ovaries, unlike the synthetic versions of those hormones. Some bioidentical hormones are available in FDA-approved, mass-produced pharmaceutical versions in the form of capsules, gels, patches and pills. Custom-compounded bioidenticals, on the other hand, are personalized mixtures of bioidentical hormones. The physician prescribes an individualized dosage of the hormones, and a compounding pharmacist prepares the treatment, possibly mixing small doses of several hormones into a single pill, cream or lozenge. Why the conflict? Some women say custom-compounding is the only thing that has helped and that they feel more comfortable with dosages that are specifically mixed for their needs. Critics say unregulated custom-compounding may put women's health at risk. To date, there is no long-term evidence that custom-compounded bioÂidentical hormones are any safer than other hormone treatments. Doctors agree, however, on the importance of reevaluating every treatment option periodically. Leyla Kokmen

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