Bioidentical hormone replacement: Safety requires oversight

The AMA at its November Interim Meeting adopted policy calling for FDA surveys of compounded hormones' purity and for adverse event reporting.

Editorial. Dec. 11, 2006.

Three is company, says the title of the 1970s sitcom. Many doctors might find one of its stars, Suzanne Somers, surprise company in the exam room.

Somers recently released her second book touting bioidentical hormones as a cure for many of the complaints of aging, including the sometimes severe symptoms of menopause. Ageless: The Naked Truth About Bioidentical Hormones quickly made a number of bestsellers' lists. It even reached No. 1 in the New York Times advice category.

Many of her readers are likely patients worried about the health risks of traditional hormone therapy discovered by Women's Health Initiative. They're eager to bring their symptoms under control and looking for safer alternatives. Chances are they're going to bring Somer's ideas up with their doctors.

Those patient-doctor conversations are a good thing because the medical profession has concerns with the safety and efficacy of these products when created through pharmaceutical compounding.

Last month, the American Medical Association took a stand on the issue at its Interim Meeting.

The Association adopted policy asking the Food and Drug Administration to conduct surveys of compounded bioidenticals for purity and accuracy. It also calls for mandatory adverse event reporting by the hormones' makers, including pharmacies, and a registry of these occurrences.

Bioidentical hormones have the same chemical and molecular structure as hormones produced in the human body. Traditional hormone therapy relies on estrogen or estrogen-progestin products made by pharmaceutical companies and approved by the FDA. Compounded bioidenticals are typically derived from plants and formulated by a pharmacy to meet individual patient needs. They are not FDA regulated.