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

[Guest guest]

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. "