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Originally published August 15 2008

FDA Goes After Natural HRT Alternatives Following Petition From Drug Giant

by David Gutierrez, staff writer

(NaturalNews) The FDA has issued a warning letter to seven pharmacies, instructing them to stop claiming that "bio-identical hormone replacement therapy" (BHRT) is different or safer than conventional hormone replacement therapy (HRT), and to stop selling prescriptions for an unapproved hormone.

The warning came in response to a petition from pharmaceutical giant Wyeth, in addition to concerns expressed by health-care companies and consumer groups.

"Many pharmacy compounders use the term bio-identical to imply that their drugs are natural," said Deborah M. Autor, director of the FDA Center for Drug Evaluation and Research's Office of Compliance. "There is no creditable scientific support for this claim."

The agency warned that the pharmacies, mostly online retailers, might face drug seizures or other sanctions if they do not correct their practices. The agency noted that with the exception of compound drugs containing estriol, which is not approved for U.S. use, the sale of BHRT drugs is not illegal.

A landmark 2002 study called the Women's Health Initiative found that HRT places post-menopausal women at increased risk of heart attacks, strokes and cancer. The FDA recommends that HRT be avoided as a treatment for menopausal symptoms. If it must be used, the lowest possible dose should be used for the shortest possible time.

Phil Pylant, owner of Village Compounding Pharmacy, which received one of the warning letters, expressed confusion as to why his pharmacy was singled out.

"I am one of 5,000 to 8,000 compounding pharmacies in the country that's doing the exact same thing - including CVS and Walgreens - and they all use the same drugs we use," Pylant said.

Pylant noted that he only fills prescriptions written by doctors, and that his pharmacy makes no health claims about HRT or BHRT.

"The claims are being made by other people," he said. "There are books being written by physicians and people who use this stuff, and they make claims. If I'm claiming anything, it's because I'm a messenger. Why kill the messenger?"

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