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FDA Launches Misguided Attack on Estriol, Despite Proof it is Safe and Effective for Women, says Dr. Erika
"Why would the FDA try to take estriol off the market when it is not only safe for women in menopause, it may even help women with multiple sclerosis," writes Dr Erika. Maybe it is because the agency is more concerned with protecting Wyeth than it is with protecting women, she says. Wyeth is the manufacturer of the top-selling synthetic hormone replacement therapies on the market. Earlier this month, the FDA sent warning letters to compounding pharmacies over the effectiveness of the bioidentical hormones prescribed by an increasing number of physicians. The agency also warned it is considering a ban on estriol. The FDA action was in response to a so-called "citizen's petition" sponsored by Wyeth.
PRWEB - January 23, 2008 - The Food and Drug Administration has launched a misguided attack on estriol despite overwhelming evidence it is safe and effective for women in menopause, according to Erika Schwartz MD at www.DrErika.com
"Why would the FDA try to take estriol off the market when it is not only safe for women in menopause, it may even help women with multiple sclerosis," writes Dr. Erika. Maybe it is because the agency is more concerned with protecting Wyeth than it is with protecting women, she says.
Why would the FDA try to take estriol off the market when it is not only safe for women in menopause, it may even help women with multiple sclerosis.
Wyeth is the manufacturer of the top-selling synthetic hormone replacement therapies on the market. Earlier this month, the FDA sent warning letters to compounding pharmacies threatening a ban on estriol. The FDA said its action was in response to a "citizen's petition" voicing concern about compounded bioidentical hormones submitted by Wyeth to the FDA October 2005.
In her blog, Dr. Erika explains what estriol is, how it works and how it has been studied in this country and overseas since the 1980s.
She notes that Jonathan Wright MD, an American leader in the field of bioidentical hormone therapies, created a combination of estriol and estradiol known as Biest to treat symptoms of menopause. The success of this combination has translated in its extensive use by compounding pharmacies around the country for the past 10 years.
Most recently estriol has been studied in the treatment of multiple sclerosis in women. It is a scientifically supported and well known fact that women who suffer with autoimmune diseases like rheumatoid arthritis, thyroiditis and MS experience significant improvement in these conditions during pregnancy. Since estriol is the dominant estrogen during pregnancy, research is presently being conducted to evaluate estriol's effect on MS.
Doses of estriol similar to those circulating in the blood stream of a pregnant woman in the middle of her pregnancy (6-8 mg/day) have shown significant remission of the disease and hold much promise. Dr. Rhonda Voskuhl at UCLA has been conducting very important estriol studies on women with MS and the results are very promising.
In an article on NeurologyReviews.com in 2002 Dr. Voskuhl was quoted as saying estriol at pregnancy doses had been given in Europe and Asia in the form of hormone replacement therapy for symptoms of menopause, "which means we didn't have to reinvent the wheel on assessing toxicity. It was very well known how this estriol preparation would be tolerated. Therefore we could go straight to a phase I clinical trials focusing on multiple sclerosis-related disease measures."
Dr. Erika says: "No adverse reactions or long term negative side-effects have been reported with the use of estriol by physicians or patients using this bioidentical hormone to the FDA to my knowledge."
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Dr. Schwartz, its founder, is dedicated to providing an honest view on health care topics and issues from a position of devoted patient advocacy.
Dr. Schwartz is an internationally-recognized patient advocate, practicing physician, expert in conventional and integrative medicine and a frequent guest on TV and radio. She has written four books, lectures on health and wellness issues and authored a magazine column read by more than 10 million people a week.