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FDA Warns Claims for Pharmacy-Made “Bio-identical” Hormones Are Misleading

FDA Warns Claims for Pharmacy-Made “Bio-identical” Hormones Are Misleading The Food and Drug Administration (FDA) is warning physicians and consumers about false and misleading claims being made by some compounding pharmacies that are marketing so-called bio-identical hormone replacement therapy (BHRT) products. The agency also has sent warning letters to 7 such pharmacies; the warnings order the pharmacies to stop making these false or misleading claims and threaten further regulatory action if they do not comply. Among the false or misleading claims the agency takes issue with are the description of these products as “bio-identical,” implying that these products are natural or identical to hormones made by the body. Additionally, the agency has warned the pharmacies to stop making unsupported claims. Such claims assert that these BHRT products are safer or more effective than FDA-approved hormone therapies and that they can treat or prevent conditions such as Alzheimer disease, stroke, heart disease, or cancers. The action was spurred by a petition from Wyeth in Madison, NJ, and physicians and consumer complaints. “The FDA is concerned that claims made by [compounding pharmacies] about so-called bio-identical hormones can mislead practitioners and consumers about the risks and benefits of these drugs,” said Deborah M. Autor, Esq, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. These so-called bio-identical hormone products may contain estrogen, progesterone, and estriol. The latter is not FDA-approved for any purpose; only pharmacies that hold a valid new or experimental drug application can compound drugs that include estriol. For some women, these products may pose the same risks as FDA-approved hormone therapies, including increased risk of blood clots, heart attack, stroke, breast cancer and gallbladder disease, said Kathleen Uhl, MD, assistant commissioner in the FDA's Office of Women's Health. “Women should be aware these products are not safer just because they are called natural,” Uhl said. The agency's actions are not targeting traditional pharmacy compounding practices, in which a pharmacist mixes drug ingredients to meet the needs of a specific patient in response to a valid prescription from a licensed physician, said Autor. For example, for a patient who has an allergy to a dye or other inactive ingredient that is found in the FDA-approved formulation of a drug, a pharmacy may compound a formulation of the drug that excludes the problematic ingredient. Such compounding meets import health needs, she said. Further information about the FDA warnings is available online at http://www.fda.gov/cder/pharmcomp/default.htm. Consumer information about so-called bio-identical hormones is also available from the FDA at http://www.fda.gov/consumer/updates/bioidenticals010908.html. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

FDA Warns Claims for Pharmacy-Made “Bio-identical” Hormones Are Misleading

Kuehn, Bridget M.
JAMA , Volume 299 (5) – Feb 6, 2008
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FDA Warns Claims for Pharmacy-Made “Bio-identical” Hormones Are Misleading

Abstract

The Food and Drug Administration (FDA) is warning physicians and consumers about false and misleading claims being made by some compounding pharmacies that are marketing so-called bio-identical hormone replacement therapy (BHRT) products. The agency also has sent warning letters to 7 such pharmacies; the warnings order the pharmacies to stop making these false or misleading claims and threaten further regulatory action if they do not comply. Among the false or misleading claims the agency...
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Publisher
American Medical Association
Copyright
Copyright © 2008 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.299.5.512
Publisher site
See Article on Publisher Site

Abstract

The Food and Drug Administration (FDA) is warning physicians and consumers about false and misleading claims being made by some compounding pharmacies that are marketing so-called bio-identical hormone replacement therapy (BHRT) products. The agency also has sent warning letters to 7 such pharmacies; the warnings order the pharmacies to stop making these false or misleading claims and threaten further regulatory action if they do not comply. Among the false or misleading claims the agency takes issue with are the description of these products as “bio-identical,” implying that these products are natural or identical to hormones made by the body. Additionally, the agency has warned the pharmacies to stop making unsupported claims. Such claims assert that these BHRT products are safer or more effective than FDA-approved hormone therapies and that they can treat or prevent conditions such as Alzheimer disease, stroke, heart disease, or cancers. The action was spurred by a petition from Wyeth in Madison, NJ, and physicians and consumer complaints. “The FDA is concerned that claims made by [compounding pharmacies] about so-called bio-identical hormones can mislead practitioners and consumers about the risks and benefits of these drugs,” said Deborah M. Autor, Esq, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. These so-called bio-identical hormone products may contain estrogen, progesterone, and estriol. The latter is not FDA-approved for any purpose; only pharmacies that hold a valid new or experimental drug application can compound drugs that include estriol. For some women, these products may pose the same risks as FDA-approved hormone therapies, including increased risk of blood clots, heart attack, stroke, breast cancer and gallbladder disease, said Kathleen Uhl, MD, assistant commissioner in the FDA's Office of Women's Health. “Women should be aware these products are not safer just because they are called natural,” Uhl said. The agency's actions are not targeting traditional pharmacy compounding practices, in which a pharmacist mixes drug ingredients to meet the needs of a specific patient in response to a valid prescription from a licensed physician, said Autor. For example, for a patient who has an allergy to a dye or other inactive ingredient that is found in the FDA-approved formulation of a drug, a pharmacy may compound a formulation of the drug that excludes the problematic ingredient. Such compounding meets import health needs, she said. Further information about the FDA warnings is available online at http://www.fda.gov/cder/pharmcomp/default.htm. Consumer information about so-called bio-identical hormones is also available from the FDA at http://www.fda.gov/consumer/updates/bioidenticals010908.html.

Journal

JAMA – American Medical Association

Published: Feb 6, 2008

Keywords: hormones,pharmacies

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