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THURSDAY, JAN 10, (News Locale) - Seven pharmacies, most of them based on the Internet, have received warning letters from the U.S. Food and Drug Administration regarding "bio-identical hormone replacement therapy" (BHRT). These hormones are rapidly gaining popularity as a treatment for menopausal symptoms among women in the United States.
BHRT drugs are the ones which include progesterone, estrogen and estriol and are touted as beneficial in helping alleviate menopausal symptoms like hot flashes and anxiety. Furthermore some pharmacies claim they prevent Alzheimer's disease and even cancer. Estriol is not approved by the FDA as a therapeutic compound.
"FDA is concerned that unfounded claims like these are misleading women and health care professionals about products known as “bioidentical hormone replacement therapy” (BHRT) for relief of the symptoms of menopause," the agency warned yesterday.
Below are some questions and answers regarding BHRT.
Why has "bio-identical hormone replacement therapy" gained popularity?
Hormone Replacement Therapy after menopause is generally viewed as a risky proposition as many studies have linked it to an increased risk of cancer and heart disease. Hormone therapy involves the intake of synthetic analogues of the hormones estrogen and progestin.
HRT is most often used to treat symptoms of menopause such as vaginal dryness, mood swings, sleep disorders, and decreased sexual desire. Some women taking HRT may experience water retention, bloating, nausea, breast soreness, mood swings, and headaches.
That is why these bio-identical hormones were thought to be a replacement for synthetic analogues of the natural hormones.
Why is the FDA warning about BHRT?
FDA encourages patients to use FDA-approved drugs whenever possible because compounded drugs are not approved by the agency. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
What is the crux of the warning?
The pharmacy operations receiving warning letters use the terms "bio-identical hormone replacement therapy" and "BHRT" to imply that their drugs are natural or identical to the hormones made by the body. FDA says use of "bio-identical" as a marketing term implying a benefit for the drug, which in reality has no medical benefits.
Furthermore pharmacy BHRT drugs contain estriol, which has never been assessed for safety and effectiveness by the FDA.
Which are the pharmacies that have come under the FDA scanner?
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 have received the warning letters.
What has been the general reaction to FDA's move?
Dr. Wulf Utian, executive director of the North American Menopause Society has welcomed the decision, "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," he said. "If you have a good reason to be on hormones, you should ask to be converted to something that has undergone FDA scrutiny."
Can BHRT products prevent or cure heart disease, Alzheimer's disease, and breast cancer?
"BHRT" drug products have not been shown to prevent or cure any of these diseases. In fact, like FDA-approved hormone therapy drugs, they may increase the risk of heart disease, breast cancer, and dementia in some women.
What is the FDA advising women?
"FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies. Women taking these drugs should discuss with their health care providers the drugs' risks and whether they're getting effective treatment," said d Dr. Janet Woodcock, FDA's chief medical officer and acting director of the agency's Center for Drug Evaluation and Research.
The informational page can be found here http://www.fda.gov/consumer/updates/bioidenticals010908.html
What are the choices for women experiencing menopausal symptoms?
The ultimate decision rests with women, who must determine their own preferences and arrive at informed decisions. Regardless of age women must have regular check-ups for blood pressure and other symptoms of heart disease. It is always better to err on the side of caution so any decision must be taken with doctor's approval.
Note: The above article is for informational purposes only and uses the FDA as a source. News Locale is not liable for information published by third parties. Please consult your doctor for medical advice.
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