Think twice before prescribing custom-compounded bioidentical hormone therapy

Journal of Women's Health

Volumn 23, Issue 8, 2014, Pages 631-633

  Pinkerton, Joann V ^a  

^a UNIVERSITY OF VIRGINIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CUSTOM COMPOUNDED HORMONE BIOIDENTICAL THERAPY; DRUG APPROVAL; DRUG EFFICACY; DRUG MONITORING; DRUG QUALITY; DRUG SAFETY; FEMALE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HORMONAL THERAPY; HUMAN; MALPRACTICE; PHARMACY; PRIORITY JOURNAL; REVIEW; DECISION MAKING; DRUG EFFECTS; DRUG FORMULATION; ESTROGEN THERAPY; MENOPAUSE; PRESCRIPTION;

PHARMACOLOGICAL BIOMARKER;

BIOMARKERS, PHARMACOLOGICAL; DECISION MAKING; DRUG COMPOUNDING; DRUG PRESCRIPTIONS; ESTROGEN REPLACEMENT THERAPY; FEMALE; HUMANS; MENOPAUSE;

EID: 84905965157     PISSN: 15409996     EISSN: 1931843X     Source Type: Journal    
DOI: 10.1089/jwh.2014.1505     Document Type: Review

References (20)

1. The basics of bioidentical hormone replacement therapy. Available at www.oprah.com/health/the-basics-of-bioidentical-hormone-replacement-therapy Accessed July 16, 2014.
2. Somers S. Bioidentical hormones and wellness. Available at www.suzannesomers.com/pages/forever-health Accessed July 16, 2014.
3. Cirigliano M. Bioidentical hormone therapy: A review of the evidence. J Womens Health. 2007;16:600-631.
4. Files JA, Ko MG, Pruthi S. Bioidentical hormone therapy. Mayo Clin Proc 2011;86:673-680.
5. Sites CK. Bioidentical hormones for menopausal therapy. Womens Health (Lond Engl) 2008;4:163-171.
6. Bhavnani BR, Stanczyk FZ. Misconception and concerns about bioidentical hormones used for custom-compounded hormone therapy. J Clin Endocrinol Metab. 2012;97:756-759.
7. Glavin, M. Letter from M. Glavin regarding Wyeth citizen petition. Available at www.fda.gov/ohrms/dockets/dockets/05p0411/BHRTletter.html Accessed July 16, 2014.
8. Cruse AE. FDA warning letter, Reed's Compounding Pharmacy. 2008. Available at www.fda.gov/iceci/enforce mentactions/warningletters/2008/ ucm1048446 htm Accessed July 14, 2014.
9. FDA Consumer Health Information. Bio-identicals: Sorting myths from facts. 2013. Available at www. fda.gov/forconsumers/consumerupdates/ucm049311. htm. Accessed July 16, 2014.
10. Davis R, Batur P, Thacker H. Risks and effectiveness of compounded bioidentical hormone therapy: A case series of patient experiences. J Womens Health 2014;23:642-648.
11. 2006 Limited FDA survey of compounded drug products. Available at www.fda.gov/drugs/guidancecompliance regulatoryinformation/pharmacycompounding/ ucm204237.htm Accessed April 14, 2014.
12. Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee. Committee opinion No. 532: Compounded bioidentical menopausal hormone therapy. Obstet Gynecol 2012;120: 411-415.
13. US Food and Drug Administration. Compounding: Inspections, recalls, and other actions. Updated June 11, 2014. Available at www.fda.gov/drugs/ guidancecompliance regulatoryinformation/pharmacycompounding/ucm339771.htm Accessed July 17, 2014.
14. Guidance: Pharmacy compounding of human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act. Available at fda.gov/downloads/ drugs/guidance complianceregulatoryinformation/guidances/ucm377052.pdf Accessed July 16, 2014.
15. Pharmacy compounding of human drug products under Section 503A of the Federal Food, Drug, and Cosmetic Act Available at www.fda.gov/downloads/drugs/ guidance complianceregulatoryinformation/guidances/ucm377052.pdf Accessed 7-16-14
16. North American Menopause Society. The 2012 hormone therapy position statement of: The North American Menopause Society. Menopause. 2012;19:257-271.
17. The Endocrine Society position statement. Bioidentical hormones. 2006. Available at www.endocrine.org/*/media/endosociety/files/ advocacy%20and%20outreach/position %20statements/all/bh-position-statement- final-10-25- 06-w-header pdf Accessed July 16, 2014.
18. Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: A review. Menopause 2004;11:356-367
19. NAMS practice pearl: What are the concerns about custom-compounded "bioidentical" hormone therapy? Menopause 2014: in press.
20. Sellers S, Utian WH. Pharmacy compounding primer for physicians: Prescriber beware. Drugs 2012:72;2043-2050.