On January 9, 2008 the FDA announced that it was sending warning letters to seven pharmacies regarding so called “bio-identical hormone replacement therapy,” “bio-identical hormones” or BHRT.
Press Release, January 23, 2008 — The FDA announced that it was sending warning letters to seven pharmacies regarding so called “bio-identical hormone replacement therapy,” “bio-identical hormones” or BHRT. The FDA warned that certain claims made about the safety and effectiveness of these products are considered false and misleading by the agency because they are not supported by medical evidence, a violation of federal law. Pharmacies which do not address the violations in the warning letters will face injunctions and seizure of the drugs.
The term BHRT is used by some to imply that those products are “natural” or “identical to the hormones made by the body” and therefore “safer and more effective” than FDA-approved preparations.
The FDA expressed concern regarding statements that these preparations can “prevent Alzheimer’s Disease” and prevent or treat stroke and various forms of cancer that are not supported by scientific evidence, a concern shared by AACE.
The FDA expresses particular concern about one of the common components of BHT, estriol. “No drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown.”
AACE President Dr. Richard Hellman said the Association fully supports this action by the FDA. Unfounded claims may mislead consumers and health care professionals. The FDA is encouraging patients to use FDA-approved drugs for menopause related complaints whenever possible, instead of relying on formulations that are not reviewed by the agency for safety and effectiveness.
This FDA action signals a clear change in the attitude toward the issue of BHRT by this governmental oversight agency. AACE believes that additional initiatives regarding BHRT are necessary to help protect the health and safety of the public, Hellman said. This should be approached with utmost diligence and objectivity. The issue of public safety should always be balanced with the individual freedom to make informed personal choices, Hellman said. Obviously, such informed personal decisions should be based upon objective information from peer reviewed and published scientific studies.
AACE recommends that patients taking these products consult their physicians to discuss this issue. If further information is required, expert endocrinologists may be found here.
AACE is a professional medical organization with nearly 6,000 members in the United States and 85 other countries. Founded in 1991, AACE is dedicated to the optimal care of patients with endocrine problems. AACE Clinical Endocrinologists advanced, specialized training enable them to be experts in the care of endocrine disease, such as diabetes, thyroid disorders, growth hormone deficiency, osteoporosis, cholesterol disorders, hypertension and obesity. For further information about AACE visit www.aace.com.