What are the concerns about custom-compounded "bioidentical "hormone therapy?

Menopause

Volumn 21, Issue 12, 2014, Pages 1298-1300

  Pinkerton, JoAnn V ^a  

^a UNIVERSITY OF VIRGINIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ESTROGEN; PROGESTERONE;

ARTICLE; BIOIDENTICAL HORMONE THERAPY; DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULATION; DRUG LABELING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HORMONAL THERAPY; HUMAN; MEDICAL SOCIETY; MEDICOLEGAL ASPECT; PHARMACY; QUALITY CONTROL; FEMALE; HORMONE SUBSTITUTION; MENOPAUSE; PROCEDURES; STANDARDS; THERAPEUTIC EQUIVALENCE; UNITED STATES; WOMEN'S HEALTH;

DRUG APPROVAL; DRUG COMPOUNDING; ESTROGENS; FEMALE; HORMONE REPLACEMENT THERAPY; HUMANS; MENOPAUSE; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOMEN'S HEALTH;

EID: 84916220790     PISSN: 10723714     EISSN: 15300374     Source Type: Journal    
DOI: 10.1097/gme.0000000000000376     Document Type: Article

References (10)

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2. US Food, Drug Administration. Bio-identicals: Sorting Myths from Facts. www.fda.gov/forconsumers/consumerupdates/ucm049311.htm. April 8, 2008. AccessedMay 15, 2014
3. Olié V, Canonico M, Scarabin PY. Risk of venous thrombosis with oral versus transdermal estrogen therapy among postmenopausal women. Curr Opin Hematol 2010;17:457-463
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5. Boothby LA, Doering PL. Bioidentical hormone therapy: A panacea that lacks supportive evidence. Curr Opin Obstet Gynecol 2008;20: 400-407
6. North American Menopause Society. The 2012 hormone therapy position statement of: The North American Menopause Society. Menopause 2012;19:257-271
7. Ramin CJ. The hormone hoax thousands fall for. More. October 2013. www.more.com/health/wellness/hormone-hoax-thousands-fall-0. Accessed May 15, 2014
8. Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware. Drugs 2012;72:2043-2050
9. Clarke T. US compounding pharmacies start to register with FDA [news release]. Reuters. January 9, 2014. www.reuters.com/article/2014/01/10/us-compounding-pharmacies-fda-idUSBREA0903120140110. Accessed May 15, 2014
10. US Food and Drug Administration. Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act. December 2013. ww.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377052.pdf. Accessed May 15, 2014.