Women taking "bio-identical hormones" generally think they're getting relief from menopausal symptoms, without the nasty risks of Big Pharma's hormone replacement therapies. But the FDA doesn't agree. The agency has cried foul to seven companies that make the products, saying these alternative hormones aren't any safer than regular HRT--plus, one common ingredient in the mix has never been reviewed and approved by government regulators.
The action will likely rein in the boom in bio-identical hormones that began when research showed that regular HRT can significantly increase the risk of stroke, heart attack, and other serious problems. The seven pharmacies warned can still sell compounded hormones, but without the unapproved ingredient estriol and without using the term "bio-identical." And the products must be prescribed by a doctor.
Though the agency denies it, the FDA's crackdown certainly appears to have been prompted by Wyeth playing tattletale. Maker of FDA-approved hormone products, Wyeth petitioned the agency to investigate compounding pharmacies that sell the bio-identical products. The FDA then got more than 70,000 comments from patients, pharmacists, and others--many defending the alternative hormones.
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