FDA Warns Against Bio-Identical Hormone Therapy

By Steven Reinberg
HealthDay Reporter
Wednesday, January 9, 2008; 8:00 PM

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WEDNESDAY, Jan. 9 (HealthDay News) -- U.S. health officials warned Wednesday about so called "bio-identical hormone replacement therapy" (BHRT) drugs, an increasing popular alternative therapy among women with menopausal symptoms.

U.S. Food and Drug Administration officials said they've sent warning letters to seven pharmacies, most of them Internet-based, saying that claims touting the benefits of BHRT compounds aren't supported by medical evidence.

"FDA has issued warning letters to seven pharmacies that make false and misleading claims about their hormone therapy drugs and compound drugs containing estriol," Deborah M. Autor, director of the FDA's Office of Compliance in the Center for Drug Evaluation and Research, said during a Wednesday afternoon teleconference.

The FDA said the seven pharmacies improperly claim that their drugs, containing hormones such as estrogen, progesterone and estriol, are better than the agency's approved menopausal hormone therapy drugs and can prevent diseases such as Alzheimer's, stroke and cancers.

Autor noted the estriol has not been approved by the FDA for any use. In fact, it's illegal to put estriol in a compound unless the maker has a valid FDA investigational new drug application, she said.

The FDA is concerned that by making these false claims, the pharmacies are misleading patients and doctors about the risks and benefits of the BHRT drugs, Autor said.

The FDA said the BHRT therapies were becoming increasingly popular, following the 2002 Women's Health Initiative finding that traditional hormone replacement therapy could have dangerous side effects, including breast cancer, heart attack and stroke.

"Many pharmacy compounders use the term bio-identical to imply that their drugs are natural or natural to hormones made by the body," Autor said. "There is no creditable scientific support for this claim."

Also, while some of the pharmacies state their drugs are safer than FDA-approved hormone-replacement therapy medications, there's no evidence that they don't have the same risks and side effects as approved drugs, Autor said.