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FDA Warns Makers of 'Bio-Identical' Hormone Replacement Therapy

Advertising may be false and deceptive, agency claims

January 10, 2008    

Hormone Replacement Therapy • Risks of Long-Term Hormone Therapy Continue to Outweigh Benefits • FDA Warns Makers of 'Bio-Identical' Hormone Replacement Therapy • HRT May Prevent Heart Attacks In Some Women • FTC Warns Hormone Replacement Therapy Promoters

The Food and Drug Administration (FDA) is warning seven pharmacies that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy" or "BHRT" products are unsupported by medical evidence, and are considered false and misleading.

In warning letters sent to the seven, the Food and Drug Administration (FDA) expressed its concern that such unfounded claims mislead women and health care professionals.

The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use), are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.

Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," said Dr. Janet Woodcock, FDA's chief medical officer and acting director of the agency's Center for Drug Evaluation and Research.

In addition to the regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies.

“Women taking these drugs should discuss with their health care providers the drugs' risks and whether they're getting effective treatment," advised Woodcock.

The pharmacy operations receiving warning letters use the terms "bio-identical hormone replacement therapy" and "BHRT" to imply that their drugs are natural or identical to the hormones made by the body. FDA regards this use of "bio-identical" as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis.

The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. No drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown.

Firms that do not properly address violations identified in warning letters risk further enforcement, including injunctions that prevent additional violations, and seizure of the violating drugs.

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