Fwd: From Dr. Vliet - FDA Takes Action Against Compounded Menopause Hormone D...

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Important Announcement from the FDA

January 10, 2008

Dr. Vliet Applauds the FDA

To all my readers, patients, and listeners on Blog Talk Radio:

With the recent FDA action on compounded hormones, I changed the topic for Monday January 14 Blog Talk Radio show to focus on "Bioidentical Hormones- Sorting Out Myths and Facts".

Many of you know that I have long been a proponent of proper use of compounded medications for individual patients based on a specific medical need, based on a physician's prescription for that patient. I have also been an outspoken critic concerning the current situation with unregulated "natural" hormone mixtures often called "BHRT" that are not physiologically sound, and potentially dangerous. Many of these formulas advertised on pharmacy websites on the internet contain hormones that can have adverse effects, or doses that are potentially dangerous, even when hyped as "safer" by celebrity gurus with no medical training.

I applaud the FDA for taking this action to stop pharmacies that are abusing or violating compounding pharmacy principles, guidelines, and regulations. Please read the attached articles to help you understand the issues. These articles also will help you see that PROPER use of compounded medicines as prescribed by a physician for an individual patient are NOT the target of this current warning action.

There are numerous FDA-approved menopause products that contain molecular copies of the human 17-beta estradiol and progesterone, such as Estrogel, Climara, Vivelle DOT, Femring, Estring, Estrace tablets and cream, estradiol tablets, Prometrium, and Prochieve. These are excellent options for women seeking alternatives to Premarin and Prempro (horse-derived estrogens alone or with a synthetic progestin).

The above commercial products have undergone safety and effectiveness studies to obtain FDA approval, and have regulatory oversight for quality control in their manufacture....which is not the case for the heavily promoted "BHRT" creams, troches, etc. being compounded in local pharmacies and sold over the internet. It's important that consumers understand the differences.

Tune in Monday night (January 14th) for a lively discussion, and more "Straight Truth About Hormones."

For your health and wellbeing, make sure you have a thorough evaluation (saliva tests in the local pharmacy are NOT enough!), proper testing, and use reputable products. Don't just follow unproven "protocols" because a particular book or speaker creates a great deal of media buzz and sales. You deserve better!

FDA Takes Action Against Compounded Menopause Hormone Therapy DrugsWed, 9 Jan 200812:28:00 -0600

The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.

For more information, see a consumer article called Bio-Identicals: Sorting Myths from Facts http://www.fda.gov/consumer/updates/bioidenticals010908.html.

Warning Letters and Q and A's are available at http://www.fda.gov/cder/pharmcomp/default.htm The Warning Letters were sent to the following pharmacies - consumers may read the violations cited to better understand these issues:

Panorama Compounding Pharmacy, Lake BalboaCA [PDF]

Saint 'sMedicalPlaza Pharmacy , Santa CA[PDF] [html]

Murray Avenue Apothecary, PIttsburgPA [PDF] [html]

Village Compounding Pharmacy, HoustonTX [PDF] [html]

Pharmacy Compounding Specialties [PDF] [html]

's Compounding Pharmacy, TucsonAZ [PDF] [html]

Pacifica Pharmacy, TorrenceCA [PDF] [html]

This educational program is free of commercial sponsorships and made possible by grants from Hormone Education and Research, Inc., a private foundation focused on women's hormone issues, and from Dr. Vliet's foundation, Straight Truth About Hormones, Inc.

Lee Vliet, M.D.

http://www.herplace.com/Medical Director, HER Place: Health Enhancement and Renewal for Women, Inc.Founder and CEO: The Straight Truth About Hormones Foundation, Inc.Mailing address: P.O. Box 64507, Tucson, AZ 85728, USAClinical Office: 520797-9131 FAX Although this email and any attachments are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by HER Place: Health Enhancement and Renewal for Women, Inc. and/or Lee Vliet, M.D. for any loss or damage arising in any way from its use. DISCLAIMER AND CAUTION:Electronic mail sent through the internet is not secure and could be intercepted by a third party. For your protection, avoid sending identifying information, such as account, Social Security, or card numbers to us or others. Further, do not send urgent or time-sensitive medical information by email, since it may not be checked regularly.

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