Navigation Links
Bio-Identical Hormone Menopause Doctor Responds to Outrageous FDA News

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:
(Date:11/24/2015)... --> --> ... by Transparency Market Research, the global non-invasive prenatal testing ... 17.5% during the period between 2014 and 2022. The ... Analysis, Size, Volume, Share, Growth, Trends and Forecast 2014 ... to reach a valuation of US$2.38 bn by 2022. ...
(Date:11/24/2015)... ... November 24, 2015 , ... In harsh industrial ... points for in-line sensors can represent a weak spot where leaking process media ... of retractable sensor housings , which are designed to tolerate extreme process conditions. ...
(Date:11/24/2015)... LOS ANGELES , Nov. 24, 2015 ... a biotechnology company focused on the discovery, development and ... Marban , Ph.D., Chief Executive Officer, is scheduled to ... December 1, 2015 at 10:50 a.m. EST, at The ... York City . . ...
(Date:11/24/2015)... ... , ... Whitehouse Laboratories is pleased to announce that it has completed construction ... dedicated to basic USP 61, USP 62 and USP 51 testing specific to raw ... and micro testing performed by one supplier. Management has formally announced that ...
Breaking Biology Technology:
(Date:11/9/2015)... 09, 2015 ... the "Global Law Enforcement Biometrics Market ... --> ) has announced the ... Biometrics Market 2015-2019" report to their ... ( ) has announced the addition ...
(Date:10/29/2015)...   MedNet Solutions , an innovative SaaS-based eClinical ... research, is pleased to announce that it has been ... one of only three finalists for a 2015 ... Growing" category. The Tekne Awards honor Minnesota ... innovation and leadership. iMedNet™ eClinical ...
(Date:10/29/2015)... Oct. 29, 2015  Connected health pioneer, Joseph ... explosion of technology-enabled health and wellness, and the business ... The Internet of Healthy Things . ... smartphones even existed, Dr. Kvedar, vice president, Connected Health, ... care delivery, moving care from the hospital or doctor,s ...
Breaking Biology News(10 mins):