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:6/23/2016)... Mass. , June 23, 2016   ... development of novel compounds designed to target cancer ... napabucasin, has been granted Orphan Drug Designation from ... the treatment of gastric cancer, including gastroesophageal junction ... stemness inhibitor designed to inhibit cancer stemness pathways ...
(Date:6/23/2016)... , June 23, 2016  The Prostate Cancer Foundation (PCF) ... precise treatments and faster cures for prostate cancer. Members of the Class of ... 15 countries. Read More About the Class of 2016 ... ... ...
(Date:6/23/2016)... ... June 23, 2016 , ... In a new case report published today ... a patient who developed lymphedema after being treated for breast cancer benefitted from an ... paradigm for dealing with this debilitating, frequent side effect of cancer treatment. ...
(Date:6/23/2016)... ... 23, 2016 , ... ClinCapture, the only free validated electronic ... showcase its product’s latest features from June 26 to June 30, 2016 for ... Disrupting Clinical Trials in The Cloud during the conference. DIA (Drug Information ...
Breaking Biology Technology:
(Date:6/3/2016)... June 3, 2016 ... Nepal hat ein ... hochsicherer geprägter Kennzeichen, einschließlich Personalisierung, Registrierung und ... der Produktion und Implementierung von Identitätsmanagementlösungen. Zahlreiche ... im Januar teilgenommen, aber Decatur wurde als ...
(Date:5/24/2016)... , May 24, 2016 Ampronix facilitates superior patient care by providing unparalleled ... medical LCD display is the latest premium product recently added to the range of ... ... ... Sony 3d Imaging- LCD Medical Display- Ampronix News ...
(Date:5/3/2016)... , May 3, 2016  Neurotechnology, a provider ... MegaMatcher Automated Biometric Identification System (ABIS) , ... multi-biometric projects. MegaMatcher ABIS can process multiple complex ... any combination of fingerprint, face or iris biometrics. ... SDK and MegaMatcher Accelerator , which ...
Breaking Biology News(10 mins):