ATTENTION! HEADS UP! Bio-Identical Hormones At Risk..Take Action to Oppose Wyeth & FDA's Actions Against Estriol!

[Guest guest]

HI All....

I just got this in (below) from Pete Heuseman at Bellevue Pharmacy (the compounding pharmacy I use) and if any of you use the compounded Bio-identical hormones (no matter from where) please, PLEASE consider doing this, every letter can mean so much.

It's not just the 7 companies that were reprimanded (and perhaps needed to be, I don't know) but it's more than that.. as they're trying to stop any scripts for 'estriol'... (our 3rd and weaker estrogen)..

''In the letters, the FDA states that it will “halt” compounding of medications containing

estriol, an estrogen produced by the human body. Estriol is one of the most widely

prescribed hormones and is regularly compounded with other bio-identical hormones

pursuant to doctors’ prescriptions for women suffering from symptoms of menopause.

Like many commonly prescribed drugs, estriol has a monograph from the U.S.

Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed

the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP

monograph could be compounded.''

Estriol by the way also can be used topically instead of 'estradiol' for vulvar health. (though I myself prefer the estradiol).

Big Pharma is at it again.

I can tell you I'd be lost without my natural bio-identical compounded hormones (both what I use systemically (Estradiol & Testosterone) for HRT replacement , as well as what I use topically (E & T) again, for my vulvar health) and have used those for many years, and topically is what turned everything around for me after suffering thru 10 yrs of hell.

I dread to think of this happening. *sigh*

Many thanks.

Hugs to all.

Dee~

NHRT-Hrt- Fw: BHRT At Risk:

Take Action to Oppose Wyeth & FDA's Actions Against Estriol!

This is just the beginning.Our response and action are needed now.We can make a difference.Please respond and send this to anyone you know that this isof interest too. The link in the alert is for pharmacists, the link for patients is:http://iacprx.convio.net/site/PageServer?pagename=P2C2001secBHRTatRisk shorter urlhttp://tinyurl.com/2984vd From: IACP P.O. Box 1365, Sugar Land, Texas 77487 Tell A Friend BHRT At Risk: Take Action to Save BHRT! Last week FDA made a horrible decision—choosing Wyeth’s wealth over patient health. FDA agreed to support Wyeth in their campaign to end compounded hormone replacement therapy—specifically by starting a crackdown on the use of estriol which FDA claims is illegal. We are calling on you to GET INVOLVED AND FIGHT BACK! We are working to engage Members of Congress to call on FDA to reverse its decision. We need your help to contact your Representatives and Senators in Congress and encourage them to stand up for the rights of women. It’s easy and effective. Simply click here to send a letter to each of your Representatives and Senators in Congress. There, you will find a sample letter that you can tailor and send to your elected officials, the Small Business Administration and FDA with one click of the mouse. Once you’ve sent your letters, you can also call your members of Congress and tell them why FDA’s action supporting Wyeth is wrong. Use IACP’s easy-to-use call alert system. Talking points and phone numbers for your members of Congress are provided within the call alert system. The time is now for us to take action to save BHRT—especially the use of estriol. We need your help to ensure that the FDA and Wyeth are not allowed to rob patients of the treatments they are prescribed to enjoy happier, healthier lives. Save the Date IACP's Annual Meeting & Compounders on Capitol Hill May 31 - June 3, 2008 JW Marriott Pennsylvania Avenue Washington , D.C. http://www.iacprx.org/

[Guest guest]

This totally SUCKS! Please take a moment and go to the link and send a letter. You may not use compounded bio-identical hormones...but as a woman, you may end up 'needing' them one day! Never ceases to amaze me what money will cause people to do! STINKS! Thanks for the Heads Up, Dee! Hugs, ChelleDee Troll wrote: HI All.... I just got this in (below) from Pete Heuseman at Bellevue Pharmacy (the compounding pharmacy I use) and if any of you use the compounded Bio-identical hormones (no matter from where) please, PLEASE consider doing this, every letter can mean so

much. It's not just the 7 companies that were reprimanded (and perhaps needed to be, I don't know) but it's more than that.. as they're trying to stop any scripts for 'estriol'... (our 3rd and weaker estrogen).. ''In the letters, the FDA states that it will “halt” compounding of medications containing estriol, an estrogen produced by the human body. Estriol is one of the most widely prescribed hormones and is regularly compounded with other bio-identical hormones pursuant to doctors’ prescriptions for women suffering from symptoms

of menopause. Like many commonly prescribed drugs, estriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.'' Estriol by the way also can be used topically instead of 'estradiol' for vulvar health. (though I myself prefer the estradiol). Big

Pharma is at it again. I can tell you I'd be lost without my natural bio-identical compounded hormones (both what I use systemically (Estradiol & Testosterone) for HRT replacement , as well as what I use topically (E & T) again, for my vulvar health) and have used those for many years, and topically is what turned everything around for me after suffering thru 10 yrs of hell. I dread to think of this happening. *sigh* Many thanks. Hugs to all. Dee~ NHRT-Hrt- Fw: BHRT At Risk: Take Action to Oppose Wyeth & FDA's Actions Against Estriol! This is just the beginning.Our response and action are needed now.We can make a difference.Please respond and send this to anyone you know that this isof interest too. The link in the alert is for pharmacists, the link for patients is:http://iacprx.convio.net/site/PageServer?pagename=P2C2001secBHRTatRisk shorter urlhttp://tinyurl.com/2984vd From: IACP P.O. Box 1365, Sugar Land, Texas 77487 Tell A Friend

BHRT At Risk: Take Action to Save BHRT! Last week FDA made a horrible decision—choosing Wyeth’s wealth over patient health. FDA agreed to support

Wyeth in their campaign to end compounded hormone replacement therapy—specifically by starting a crackdown on the use of estriol which FDA claims is illegal. We are calling on you to GET INVOLVED AND FIGHT BACK! We are working to engage Members of Congress to call on FDA to reverse its decision. We need your help

to contact your Representatives and Senators in Congress and encourage them to stand up for the rights of women. It’s easy and effective. Simply click here to send a letter to each of your Representatives and Senators in Congress. There, you will find a sample letter that you can tailor and send to your elected officials, the Small Business Administration and FDA with one click of the mouse. Once you’ve sent your letters, you can also call your members of Congress and tell them why FDA’s action supporting Wyeth is wrong. Use IACP’s easy-to-use call alert system. Talking points and phone numbers for your members of Congress are provided within the call alert system. The time is now for us to take action to save BHRT—especially the use of estriol. We need

your help to ensure that the FDA and Wyeth are not allowed to rob patients of the treatments they are prescribed to enjoy happier, healthier lives. Save the Date IACP's Annual Meeting & Compounders on Capitol Hill

May 31 - June 3, 2008 JW Marriott Pennsylvania Avenue Washington , D.C. http://www.iacprx.org/

[Guest guest]

FDA does not approve compounded drugs so of course they would not approve

estriol as a compounded drug.

http://www.fda.gov/consumer/updates/compounding053107.html

" But consumers need to be aware that compounded drugs are not FDA-approved, "

says.

" This means that FDA has not verified their safety and effectiveness. "

---------------

Enforcement

" FDA historically hasn't directed enforcement against pharmacies engaged in

traditional compounding, " says . " Rather, we've focused on

establishments whose activities raise the kinds of concerns normally

associated with a drug manufacturer and whose compounding practices

result in significant violations of the new-drug, adulteration, or

misbranding provisions of the Federal Food, Drug, and Cosmetic Act. "

FDA counts compounded drugs among the new drugs that are covered

under the Act. " We consider them new because they're not generally

recognized among experts as safe and effective, " says .

She adds that FDA recognizes that states have a central role in regulating

pharmacy compounding.

" We refer complaints to the states, support them when they request it,

and cooperate in investigations and follow-up actions. But there are cases

when states are unable to act, and we proceed without them, " says.

--------------------------

The letters do not actually state that FDA wants to " halt " ........... - they

state that they want to " halt " the individual companies compounding of drugs

containing estriol ostensibly because they are making false claims for estriol.

Each of the letters sent to the seven companies contain the following statement.

" Your firm is compounding drugs containing estriol, which is not a

component of an FDA-approved drug, without an FDA-sanctioned IND.

These are unapproved new drugs and their compounding violates

section 505(a) of the FDCA. Based on FDA's consideration of the

circumstances he re, FDA is prepared to take enforcement action to halt

your compounding of drugs containing estriol. "

Ora

>HI All....

>

>I just got this in (below) from Pete Heuseman at Bellevue Pharmacy (the

compounding pharmacy I use) and if any of you use the compounded Bio-identical

hormones (no matter from where) please, PLEASE consider doing this, every

letter can mean so much.

>

>It's not just the 7 companies that were reprimanded (and perhaps needed to be,

I don't know) but it's more than that.. as they're trying to stop any scripts

for 'estriol'... (our 3rd and weaker estrogen)..

>

> ''In the letters, the FDA states that it will " halt " compounding of

medications containing

> estriol, an estrogen produced by the human body. Estriol is one of the most

widely

> prescribed hormones and is regularly compounded with other bio-identical

hormones

> pursuant to doctors' prescriptions for women suffering from symptoms of

menopause.

> Like many commonly prescribed drugs, estriol has a monograph from the U.S.

> Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it

passed

> the FDA Modernization Act in 1997, Congress clearly indicated that drugs with

a USP

> monograph could be compounded.''

>

>Estriol by the way also can be used topically instead of 'estradiol' for vulvar

health. (though I myself prefer the estradiol).

>

>Big Pharma is at it again.

>

>I can tell you I'd be lost without my natural bio-identical compounded hormones

(both what I use systemically (Estradiol & Testosterone) for HRT replacement ,

as well as what I use topically (E & T) again, for my vulvar health) and have

used those for many years, and topically is what turned everything around for me

after suffering thru 10 yrs of hell.

>

>I dread to think of this happening. *sigh*

>Many thanks.

>

>Hugs to all.

>Dee~