FDA Warns Against Bio-Identical Hormone Therapy
The menopause drugs are unregulated and could be dangerous, agency says.
By Steven Reinberg
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(SOURCES: Wulf Utian, M.D., Ph.D., executive director, North American Menopause Society, Cleveland; Phil Pylant, owner, Village Compounding Pharmacy, Houston; Jan. 9, 2008, teleconference with Deborah M. Autor, Esq., director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration)
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.
Pharmacies that don't address these violations run the risk of further enforcement, including injunctions and seizure of these drugs. However, the pharmacies can continue to make BHRT compounds as long as they don't contain estriol and don't make false claims, Autor said.
The FDA action isn't intended to target pharmacists who practice traditional pharmacy compounding -- combining or altering drug ingredients for an individual patient in response to a doctor's prescription -- and don't make false or misleading claims about compounded products, Autor said.
The FDA also received a petition from the drug maker Wyeth, of Madison, N.J., which asked the agency to take action against compounding pharmacy operations that produce compounded BHRT drugs. Others who have expressed concerns about these compounds include health-care providers and consumer groups, according to the FDA.
The seven pharmacies are Panorama Compounding Pharmacy of Lake Balboa, Calif.; Saint John's Medical Plaza Pharmacy of Santa Monica, Calif.; Murray Avenue Apothecary of Pittsburgh; Village Compounding Pharmacy of Houston; Pharmacy Compounding Specialties of Dallas; Reed's Compounding Pharmacy of Tucson, Ariz.; and Pacifica Pharmacy of Torrance, Calif.
Dr. Wulf Utian, executive director of the North American Menopause Society, said he supported the FDA's action.
"The FDA has done the right thing, and it's a pity it didn't happen sooner," Utian said. "We have no idea about the risks and benefits of these compounds, because they have not been subjected to the scrutiny the FDA gives to approved hormonal medications.
"If you are on a product that hasn't been FDA approved, you should see your doctor," he added. "If you have a good reason to be on hormones, you should ask to be converted to something that has undergone FDA scrutiny."
If a woman must take hormone replacement therapy to ease the symptoms of menopause, she should take the lowest possible dose for the shortest amount of time, the FDA said.
Phil Pylant, the owner of Village Compounding Pharmacy, said he couldn't figure out why his company was being singled out by the FDA. "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. Why they picked me out, I have no idea."
Pylant noted that all his compounds are made to order from a doctor's prescription. "We are order-takers, pharmacies cannot do anything without an authorized written prescription," he said. "If FDA had indicated that estriol was illegal, we wouldn't have used it.
"I don't make health claims," Pylant added. "The claims are being made by other people. 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?"
For more on bio-identical hormone therapy, visit the U.S. Food and Drug Administration.
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