FDA Warns Pharmacies Not to Compound Commonly-Prescribed Hormone Estriol,
Not to Use the Term 'Bio-identical'
SPOKANE, Wash., Jan. 11 /PRNewswire/ -- "The FDA statement regarding compounded estrogens -- which include estradiol and estriol -- progesterone, and other compounded hormones was very surprising to me and other medical experts in the field of Women's Hormones," remarks Cheryle Hart, M.D. She is Mayo Clinic trained and Board certified in Ob/Gyn and founded what is now Hormones by Hart in 1997. She is also the medical director of Hormones by Hart.
The FDA stated on January 9, 2008 that pharmacies cannot use the term "bio-identical" to describe the hormones they are compounding. "Even though the hormones they are using are actually chemically identical to what is produced by the human body," says Dr. Hart.
"I am astounded that the FDA does not recognize that estradiol, progesterone, testosterone, and DHEA are chemically identical to hormones found in our bodies, and are therefore bio-identical. I don't know what 'substantial evidence' they are waiting for to figure that one out."
According to their news release, the FDA does not approve of the use of the estrogen estriol in any compounded formula. They consider this the manufacture of an unapproved drug. "This is certainly news to me, since estriol is one of the types of hormones naturally found in a woman's body. For the FDA to say that menopausal women cannot benefit from the use of Estriol in HRT amazes me. I would certainly like the FDA to reconsider the published evidence on this estrogen and change their ruling," comments Dr. Hart.
Because of the misleading title of the FDA News release, Dr. Hart wants to reassure her patients that while it sounds like FDA is banning compounded bio-identical hormones, it is not banning the compounded hormones.
"It is really up to the compounding pharmacies and their organizations, PCCA and IACP to get this straightened out with the FDA. Since the FDA's new position is that compounds containing estriol represent a 'new drug' it would be improper for me or any other medical practitioner to continue to prescribe Estriol compounds at this time," says Cheryle Hart, M.D.
|SOURCE Cheryle R. Hart, M.D.|
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