A New Week, a New Tack by the FDA

June 23, 2008
Category: Uncategorized

The latest attack on bio-identical hormones comes from FDA staffers telling Congress that even though estriol is the weakest estrogen, it is being prescribed to women in “mega dosages.” They are saying that this makes it potentially harmful, which is why they are insisting on doctors having to file an IND (investigational new drug) application.
We have always heard that 1-2mg/day of estriol is the average that many doctors prescribe though it could be as high as 4 mg/day.  There is currently a double-blind, placebo-controlled trial using 8 mg/day.  Wyeth’s European product contained 2mg/daily.
Of course, we have yet been able to get a response from the FDA on where they are getting their information about “mega-dosing” of estriol as bio-identical hormones.  So we decided to do some digging on our own.
With help from American College for Advancement in Medicine (ACAM) and International College of Integrative Medicine (ICIM), we have been gathering the dosing information from doctors around the nation.  We are preparing our response to the FDA and to Congress about the correct estriol dosing information.

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