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:11/27/2015)... November 27, 2015 ... popularity of companion diagnostics is one of ... market with pharmaceutical companies and diagnostic manufacturers ... tests. . --> ... report on global cancer biomarkers market spread ...
(Date:11/25/2015)... , Nov. 25, 2015  PharmAthene, Inc. (NYSE MKT: ... adopted a stockholder rights plan (Rights Plan) in an ... loss carryforwards (NOLs) under Section 382 of the Internal ... --> PharmAthene,s use of its NOLs could be ... as defined in Section 382 of the Code. In ...
(Date:11/25/2015)... , Nov. 25, 2015  Neurocrine Biosciences, Inc. ... Gorman , President and CEO of Neurocrine Biosciences, will ... Conference in New York . ... visit the website approximately 5 minutes prior to the ... replay of the presentation will be available on the ...
(Date:11/25/2015)... PORTLAND, Oregon , November 25, 2015 /PRNewswire/ ... Deep Market Research Report is a professional and ... Genomics industry.      (Logo: ... basic overview of the industry including definitions, classifications, ... analysis is provided for the international markets including ...
Breaking Biology Technology:
(Date:11/10/2015)... 10, 2015  In this report, the ... of product, type, application, disease indication, and ... report are consumables, services, software. The type ... biomarkers, efficacy biomarkers, and validation biomarkers. The ... diagnostics development, drug discovery and development, personalized ...
(Date:11/2/2015)... Calif. , Nov. 2, 2015  SRI International ... million to provide preclinical development services to the National ... contract, SRI will provide scientific expertise, modern testing and ... variety of preclinical pharmacology and toxicology studies to evaluate ... --> The PREVENT Cancer Drug Development Program ...
(Date:10/29/2015)... , Oct. 29, 2015  Connected health pioneer, ... driving the explosion of technology-enabled health and wellness, and ... new book, The Internet of Healthy Things ... sensors or smartphones even existed, Dr. Kvedar, vice president, ... of health care delivery, moving care from the hospital ...
Breaking Biology News(10 mins):