Re: Here we go again - FDA Cracking down on Bioidenticals, especially ESTRIOL

[Guest guest]

Unreal! I just got a prescription for Estriol from my doc. I have a rx but wonder if I can get it filled now. There is some mess going on with Armour I am told too. They are forcing all the grandfathered drugs to get certified and Armour is one of them.

What a nightmare. The FDA has lost their minds. I got my life back with Armour and BHrt.

Steph

Here we go again - FDA Cracking down on Bioidenticals, especially ESTRIOL

This was on CBS "Early Show" this morning. Take note of the sentence regarding estriol. Did any of you know it was ILLEGAL to sell this in the US????? I have NEVER heard this. What on earth is going on with that FDA? Like anything they approve is okay!!! What a joke! See below: Government health officials began cracking down Wednesday on Internet sales of custom-mixed hormones for menopausal women, a market created when doctors deemed prescription estrogen therapy too risky for many patients. But the Food and Drug Administration says these alternative hormone mixes are no safer, and the agency told seven makers to stop claiming they are. The FDA also said some mixes contain estriol, which is illegal to be sold in the U.S. because the FDA has not approved it for any use. In letters to the pharmacies, the FDA said the claims about the "bioidentical hormone replacement therapy" (BHRT) products are not supported by medical evidence and that the pharmacy operations are breaking the law by making false and misleading claims about the drugs. "We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," the FDA's chief medical officer, Dr. Janet Woodcock, said in a statement. The agency said it is concerned that the claims for safety and effectiveness mislead patients, doctors and other health care professionals. In addition to citing the menopausal use, some pharmacies claimed the products could prevent or treat serious diseases, including Alzheimer's, stroke and some cancers, the agency said. Officials said there is no credible evidence to support those claims. Dr. Kathleen Uhl of the agency's office of women's health said the FDA does not know how widely these drugs are used. But the said the FDA has received a growing number of questions about them. Women need to know that all drugs have both benefits and risks, and that patients should discuss them with their doctor, Uhl said. The FDA urges women to take the lowest effective dose of hormone replacement drugs that it has approved for menopausal symptoms. The agency does not review compounded, or custom-mixed, drugs for safety and effectiveness, and encourages patients to use FDA-approved drugs whenever possible. A 2002 study found replacement hormones made by drug companies raised the risk of heart attacks, breast cancer and strokes. Since then, many women have turned to the estrogen, progesterone and testosterone products sold by compounding pharmacies. Medical researchers concluded in 2003 that hormone replacement pills should be taken only as a brief treatment to help women cope with the worst symptoms of menopause. The drug company Wyeth later complained to the FDA about the Internet sales of compounded products. L.D. King, executive director of the International Academy of Compounding Pharmacists, charged that the FDA's action will deny hundreds of thousands of women access to many commonly compounded bioidentical hormones, "substituting its judgment for that of doctors."

[Guest guest]

What about Ortho-Gynest Cream--0.01% Estriol and other Brand Name

vaginal Estriol products? Are they not available at any pharmacy in

the US?

Kathy

>

> This was on CBS " Early Show " this morning. Take note of the sentence

> regarding estriol. Did any of you know it was ILLEGAL to sell this

> in the US????? I have NEVER heard this. What on earth is going on

> with that FDA? Like anything they approve is okay!!! What a joke!

>

> See below:

>

>

>

> Government health officials began cracking down Wednesday on Internet

> sales of custom-mixed hormones for menopausal women, a market created

> when doctors deemed prescription estrogen therapy too risky for many

> patients.

>

> But the Food and Drug Administration says these alternative hormone

> mixes are no safer, and the agency told seven makers to stop claiming

> they are. The FDA also said some mixes contain estriol, which is

> illegal to be sold in the U.S. because the FDA has not approved it

> for any use.

>

> In letters to the pharmacies, the FDA said the claims about

> the " bioidentical hormone replacement therapy " (BHRT) products are

> not supported by medical evidence and that the pharmacy operations

> are breaking the law by making false and misleading claims about the

> drugs.

>

> " We want to assure that Americans receive accurate information about

> the risks and benefits of drug therapies, " the FDA's chief medical

> officer, Dr. Janet Woodcock, said in a statement.

>

> The agency said it is concerned that the claims for safety and

> effectiveness mislead patients, doctors and other health care

> professionals.

>

> In addition to citing the menopausal use, some pharmacies claimed the

> products could prevent or treat serious diseases, including

> Alzheimer's, stroke and some cancers, the agency said. Officials said

> there is no credible evidence to support those claims.

>

> Dr. Kathleen Uhl of the agency's office of women's health said the

> FDA does not know how widely these drugs are used. But the said the

> FDA has received a growing number of questions about them.

>

> Women need to know that all drugs have both benefits and risks, and

> that patients should discuss them with their doctor, Uhl said.

>

> The FDA urges women to take the lowest effective dose of hormone

> replacement drugs that it has approved for menopausal symptoms.

>

> The agency does not review compounded, or custom-mixed, drugs for

> safety and effectiveness, and encourages patients to use FDA-approved

> drugs whenever possible.

>

> A 2002 study found replacement hormones made by drug companies raised

> the risk of heart attacks, breast cancer and strokes. Since then,

> many women have turned to the estrogen, progesterone and testosterone

> products sold by compounding pharmacies.

>

> Medical researchers concluded in 2003 that hormone replacement pills

> should be taken only as a brief treatment to help women cope with the

> worst symptoms of menopause.

>

> The drug company Wyeth later complained to the FDA about the Internet

> sales of compounded products.

>

> L.D. King, executive director of the International Academy of

> Compounding Pharmacists, charged that the FDA's action will deny

> hundreds of thousands of women access to many commonly compounded

> bioidentical hormones, " substituting its judgment for that of

> doctors. "

>

>

>

[Guest guest]

The FDA is in cahoots with the drug companies!! If they are so

worried about bioidenticals being safe, why the hell don't they set

up a study already to SEE IF IT IS TRUE OR NOT???? Bottom line here

is that they do not CARE about helping women! As I said, let the MEN

have some hot flashes and arthritis and see what they would do if

some estrogen alleviated those symptoms. I am so tired of this

already.

>

> Unreal! I just got a prescription for Estriol from my doc. I have

a rx but wonder if I can get it filled now. There is some mess

going on with Armour I am told too. They are forcing all the

grandfathered drugs to get certified and Armour is one of them.

>

> What a nightmare. The FDA has lost their minds. I got my life

back with Armour and BHrt.

>

> Steph

>

>

> ----- Original Message -----

>

[Guest guest]

It makes no sense. I think CBS misquoted.

> >

> > This was on CBS " Early Show " this morning. Take note of the

sentence

> > regarding estriol. Did any of you know it was ILLEGAL to sell

this

> > in the US????? I have NEVER heard this. What on earth is going

on

> > with that FDA? Like anything they approve is okay!!! What a

joke!

> >

> > See below:

> >

> >

> >

> > Government health officials began cracking down Wednesday on

Internet

> > sales of custom-mixed hormones for menopausal women, a market

created

> > when doctors deemed prescription estrogen therapy too risky for

many

> > patients.

> >

> > But the Food and Drug Administration says these alternative

hormone

> > mixes are no safer, and the agency told seven makers to stop

claiming

> > they are. The FDA also said some mixes contain estriol, which is

> > illegal to be sold in the U.S. because the FDA has not approved

it

> > for any use.

> >

> > In letters to the pharmacies, the FDA said the claims about

> > the " bioidentical hormone replacement therapy " (BHRT) products

are

> > not supported by medical evidence and that the pharmacy

operations

> > are breaking the law by making false and misleading claims about

the

> > drugs.

> >

> > " We want to assure that Americans receive accurate information

about

> > the risks and benefits of drug therapies, " the FDA's chief

medical

> > officer, Dr. Janet Woodcock, said in a statement.

> >

> > The agency said it is concerned that the claims for safety and

> > effectiveness mislead patients, doctors and other health care

> > professionals.

> >

> > In addition to citing the menopausal use, some pharmacies claimed

the

> > products could prevent or treat serious diseases, including

> > Alzheimer's, stroke and some cancers, the agency said. Officials

said

> > there is no credible evidence to support those claims.

> >

> > Dr. Kathleen Uhl of the agency's office of women's health said

the

> > FDA does not know how widely these drugs are used. But the said

the

> > FDA has received a growing number of questions about them.

> >

> > Women need to know that all drugs have both benefits and risks,

and

> > that patients should discuss them with their doctor, Uhl said.

> >

> > The FDA urges women to take the lowest effective dose of hormone

> > replacement drugs that it has approved for menopausal symptoms.

> >

> > The agency does not review compounded, or custom-mixed, drugs for

> > safety and effectiveness, and encourages patients to use FDA-

approved

> > drugs whenever possible.

> >

> > A 2002 study found replacement hormones made by drug companies

raised

> > the risk of heart attacks, breast cancer and strokes. Since then,

> > many women have turned to the estrogen, progesterone and

testosterone

> > products sold by compounding pharmacies.

> >

> > Medical researchers concluded in 2003 that hormone replacement

pills

> > should be taken only as a brief treatment to help women cope with

the

> > worst symptoms of menopause.

> >

> > The drug company Wyeth later complained to the FDA about the

Internet

> > sales of compounded products.

> >

> > L.D. King, executive director of the International Academy of

> > Compounding Pharmacists, charged that the FDA's action will deny

> > hundreds of thousands of women access to many commonly compounded

> > bioidentical hormones, " substituting its judgment for that of

> > doctors. "

> >

> >

> >

>

[Guest guest]

CBS is clearly not

understanding. Yesterday, Vliet

sent out an email clarifying the FDA action. The FDA is taking action against several

compounders who are mis-advertising the benefits (and lack of danger) of their

compounded hormones.

Val

From: rhythmicliving

[mailto:rhythmicliving ] On

Behalf Of

This was on CBS " Early Show " this morning. Take note of the

sentence

regarding estriol. Did any of you know it was ILLEGAL to sell this

in the US????? I have NEVER heard this. What on earth is going on

with that FDA? Like anything they approve is okay!!! What a joke!

[Guest guest]

Thanks Val for reminding me to read that email in my box! I am glad

you are keeping up on what Dr. V sends out and are listening to her

radio program. It is really nice when you keep us updated with what

she is sending out and saying. Thanks again.

Kathy

>

> CBS is clearly not understanding. Yesterday, Vliet sent out an email

> clarifying the FDA action. The FDA is taking action against several

> compounders who are mis-advertising the benefits (and lack of danger) of

> their compounded hormones.

>

> Val

>

> From: rhythmicliving

[mailto:rhythmicliving ]

> On Behalf Of

>

>

> This was on CBS " Early Show " this morning. Take note of the sentence

> regarding estriol. Did any of you know it was ILLEGAL to sell this

> in the US????? I have NEVER heard this. What on earth is going on

> with that FDA? Like anything they approve is okay!!! What a joke!

>

[Guest guest]

Actually Val, the doctor who gives daily medical reports on CBS

actually stated that the FDA wants the compounders to stop using

estriol because it is not FDA approved. But how could doctors be

giving us prescriptions for it if it is not FDA approved?

>

> CBS is clearly not understanding. Yesterday, Vliet sent out an

email

> clarifying the FDA action. The FDA is taking action against several

> compounders who are mis-advertising the benefits (and lack of

danger) of

> their compounded hormones.

>

> Val

>

> From: rhythmicliving

[mailto:rhythmicliving ]

> On Behalf Of

>

>

> This was on CBS " Early Show " this morning. Take note of the

sentence

> regarding estriol. Did any of you know it was ILLEGAL to sell this

> in the US????? I have NEVER heard this. What on earth is going on

> with that FDA? Like anything they approve is okay!!! What a joke!

>

[Guest guest]

Val - once and for all, I would like to know why doctors keep pushing

the estriol instead of estradiol. And why wasn't it FDA approved?

>

> CBS is clearly not understanding. Yesterday, Vliet sent out an

email

> clarifying the FDA action. The FDA is taking action against several

> compounders who are mis-advertising the benefits (and lack of

danger) of

> their compounded hormones.

>

> Val

>

> From: rhythmicliving

[mailto:rhythmicliving ]

> On Behalf Of

>

>

> This was on CBS " Early Show " this morning. Take note of the

sentence

> regarding estriol. Did any of you know it was ILLEGAL to sell this

> in the US????? I have NEVER heard this. What on earth is going on

> with that FDA? Like anything they approve is okay!!! What a joke!

>

[Guest guest]

Personally I tried straight estradiol and never felt well so I think

everyone is different and for me bi-est works so much better. Trial

and error. Just like some can tolerate the WP and others NOT. Now

that protocol personally scares me but again some tolerate it. I

would love to see research on the different methods but so far none.

Well BFN and stay well.

Barbara

>

> , not all doctors " push estriol. " Certainly, mine doesn't. I

think a

> lot of " natural " ones are stuck in the Lee,

era and do

> not keep up with research.

>

> Val

>

> From: rhythmicliving

[mailto:rhythmicliving ]

> On Behalf Of

>

>

> Val - once and for all, I would like to know why doctors keep

pushing

> the estriol instead of estradiol. And why wasn't it FDA approved?

>

>

>