Navigation Links
Bio-Identical Hormone Menopause Doctor Responds to Outrageous FDA News
Date:1/11/2008

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.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Survival Data Presented From Phase II Study of Investigational Drug ZD4054 in Hormone-Resistant Prostate Cancer Patients
2. Video and Photo: EMD Serono Launches easypod(R), New Electronic Growth Hormone Injection Device
3. Patient Treatment for Bipolar Disorder Varies Depending on Doctor Specialty; Well Designed Clinical Trials May Be The Answer
4. Medical Breakthrough ... Doctor Discovers Penetrating Carrier That Eradicates Fungus
5. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
6. ImmuneRegen Responds to Defense Threat Reduction Agency Request for Information
7. Updated Drug Development Scrip Report Responds to the Pharma Industrys Major Changes
8. Michigan Catholic Conference Responds to Formation of Embryonic Stem Cell Research Ballot Committee
9. GlaxoSmithKline Responds to JAMA Article on the ICES Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes
10. CryoLife Responds to Inaccurate Assertions from Plaintiffs Attorney
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/5/2016)... ... May 05, 2016 , ... American Process, Inc. ... patents, U.S. Patent Nos. 9,322,133 and 9,322,134, to API and its affiliated companies ... well as hydrophobic nanocellulose compositions. In addition to these patents and U.S. ...
(Date:5/4/2016)... ... May 04, 2016 , ... ... further than LaJollaCooks4u, San Diego’s premiere hands-on cooking experience. Offering everything from gourmet ... mom an experience she won’t forget. , Guests that visit LaJollaCooks4u share an ...
(Date:5/4/2016)... May 4, 2016 According to ... "Metabolomics Market - Global Industry Analysis, Size, Share, Growth, ... is anticipated to expand at a CAGR of 17.1% ... by 2024. Metabolomics is the extensive study ... biofluids, tissues or organisms. Together, these small molecules and ...
(Date:5/3/2016)... ... May 03, 2016 , ... Morf Media Inc ... training platform on mobile devices, today released a new interactive Food and ... Devices. The course is essential for owners or operators of places of business ...
Breaking Biology Technology:
(Date:3/31/2016)...  Genomics firm Nabsys has completed a financial  restructuring ... , M.D., who returned to the company in October ... team, including Chief Technology Officer, John Oliver , ... and Vice President of Software and Informatics, Michael ... Dr. Bready served as CEO of Nabsys from 2005-2014 ...
(Date:3/21/2016)... March 22, 2016 Unique ... passcodes for superior security   ... provider of secure digital communications services, today announced it ... and offer enterprise customers, particularly those in the Financial ... and voice authentication within a mobile app, alongside, and ...
(Date:3/14/2016)... March 14, 2016 NXTD ) ("NXT-ID" ... commerce market, announces the airing of a new series of ... week of March 21 st .  The commercials will air ... popular Squawk on the Street show. --> NXTD ... growing mobile commerce market, announces the airing of a new ...
Breaking Biology News(10 mins):