Bioidentical hormone compounds need greater scrutiny, AMA says

The Association's new policy requests that the FDA require patient information in packaging of these treatments.

By Damon Adams — Posted Dec. 4, 2006

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The AMA House of Delegates is urging the Food and Drug Administration to conduct surveys for purity and dosage accuracy of all compounded "bioidentical hormone" formulations. The new policy also calls for mandatory reporting of adverse events and uniform patient information on such products.

Concern is focused on the safety and efficacy of bioidentical hormone compounds, said AMA Trustee Ardis D. Hoven, MD.

Delegates said direct-to-consumer advertising lacked oversight and consumers may be getting misleading and flawed information about custom-compounded bioidentical hormones. Patients can obtain bioidentical hormones from compounding pharmacies, where the hormones may be changed for individual customization, delegates said.

Policy adopted at the Interim Meeting last month urges the FDA to require mandatory reporting by drugmakers, including compounding pharmacies, of adverse events related to use of bioidentical hormones. It asks the FDA to create a registry of adverse events.

The policy also calls on the agency to require uniform patient information, such as precautions and warnings, in product packaging. In addition, the FDA should prohibit the use of the term "bioidentical hormones" unless the preparation has been approved by the agency.

AMA leaders said the FDA is aware of concerns about the hormone compounds and plans to address the issue.

"There is no scientific basis for claims that compounded hormone therapies have a different risk-benefit ratio than FDA-approved hormone replacement therapies," Dr. Hoven said in a statement. "Confidence in the safety and effectiveness of the therapies patients take is absolutely essential for both patients and physicians."

The Endocrine Society, which, along with other groups, introduced the measure for consideration, praised the new AMA policy.

"The inconsistencies and unknown risks of bioidentical hormones are of great concern," society president Leonard Wartofsky, MD, MPH, said in a statement. "Without proper oversight and control, the public has no way of knowing precisely what they're getting or what effect it will have on an individual's body."

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