FDA Orders End to False Claims About Custom Hormone Remedies

The Food and Drug Administration warned seven pharmacies to stop selling so-called “custom-mixed hormones” as remedies for symptoms of menopause. The FDA warned that these products, also called “bio-identical hormone replacement therapy” or BHRT, are not supported by medical evidence and are the marketing of them has been considered false and misleading in some cases, reports the Associated Press.

‘This is a good decision. It is encouraging to see that the FDA can make a decision that is good for women and good for science,’ said Cynthia Pearson, Executive Director of the National Women’s Health Network.

Some companies have claimed that these BHRT products would have better results than FDA-approved menopause remedies, and that they could even be used to prevent and treat serious conditions such as Alzheimer’s, strokes and cancer, according the FDA.

Compounded drugs like these BHRT products are not reviewed by the FDA for safety and effectiveness. The FDA encourages patients to use FDA-approved drugs whenever possible, and offers more information on the facts and myths of so-called “bio-identical hormone replacement therapy” drugs.


Food and Drug Administration 1/9/08; Associated Press 1/9/08; Wall Street Journal 1/10/08

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