FDA Cracking down on Hormones

[Tclosetgirl (imported)]

FDA cracks down on custom-made hormones By RANDOLPH E. SCHMID, AP Science Writer

WASHINGTON - Government health officials on Wednesday began cracking down on Internet sales of custom-mixed hormones for menopausal women, a market born when doctors deemed prescription estrogen therapy too risky for many.

But the Food and Drug Administration says these alternative hormone mixes are no safer, and told seven makers to stop selling them.

The FDA said it sent warning letters to the companies saying their claims about the "bio-identical hormone replacement therapy" or BHRT products are not supported by medical evidence and are considered false and misleading.

"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," Dr. Janet Woodcock, FDA's chief medical officer, said in a statement.

The agency said it is concerned that the claims for safety and effectiveness mislead patients, as well as doctors and other health care professionals.

Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible, the agency said.

The warning letters say the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

Following a 2002 study that found replacement hormones made by drug companies raised the risk of heart attacks, breast cancer and strokes, many women 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 weather the worst symptoms of menopause.

The drug company Wyeth later complained to the FDA about the Internet sales of compounded products.

[jemagirl (imported)]

I sometimes wonder who's interests the FDA is really looking out for. This FDA decision is no doubt welcome news for the big pharmaceutical companies. While I agree

claims about the "bio-identical hormone replacement therapy"

may be misleading, I see the crackdown by the FDA as taking away a person's right to choose what they want to put in their body.

If I am right about the pattern we can expect to see similar crackdowns on herbal remedies in the not too distant future.

[IbPervert (imported)]

I would suggest writing the FDA a snail mail letter or send them a message by internet...

by internet go to this link and fill what you want to say

http://www.fda.gov/cder/comment.htm

or

U. S. Food and Drug Administration

5600 Fishers Lane

Rockville MD 20857-0001

Tell them how you feel and get others to do the same...it may make a

difference!

[mrt (imported)]

Yeah it makes so much more sense to use "synthetic" hormones that are created with Horse pee then the same identical hormones that humans have... SIGH... FDA? Is there anyone home???

And how about this great women's health study? Let pump massive amounts of this synthetic crap (only) into older women who have been in menopause for decades and see if being shifted into youthful range gives them a heart attack? Is ANYONE surprised?

Why not do the study with younger women (no 60 and 70 year old ladies) keeping them at normal levels and try using both synthetics AND human hormones and see a few things...

Like if there IS a difference? I'm willing to bet some money here that Horse Based synthetics cause more health issues then human hormones. Why should anyone HAVE to use synthetics now? They have a variety of human identical hormones available...

And since we are not cramming massive amounts into frail old ladies will we see strokes, heart issues etc? Again I'll bet money that human hormones in normal levels won't hurt women.

I wonder WHY no one has done such a study? Does it have anything to do with the inability of the drug folks to "patent" human hormones?

Hummmmmm......

I agree - DO get involved!

[IbPervert (imported)]

I agree - DO get involved!

WOW! This is a rare day MrT and I both agree!

[plix (imported)]

All that WHI study showed is that using horse E in older women has a higher chance of health problems. I don't bother even considering it for making any determination of the safety of E because horse E and human E are fundamentally different, and neither belongs in the body of the other. Yet somehow it's just assumed that these horse E results can be generalized to all forms of E, including E that is natural to the human body. How that assumption is made I don't know. It makes no sense to me.

Is Wyeth trying to suggest that their horse E that has been shown to cause health problems is safer than E that is naturally produced in the humam body simply because it has the backing of a government agency that works for big business?

[mrt (imported)]

All that WHI study showed is that using horse E in older women has a higher chance of health problems. I don't bother even considering it for making any determination of the safety of E because horse E and human E are fundamentally different, and neither belongs in the body of the other. Yet somehow it's just assumed that these horse E results can be generalized to all forms of E, including E that is natural to the human body. How that assumption is made I don't know. It makes no sense to me.

Is Wyeth trying to suggest that their horse E that has been shown to cause health problems is safer than E that is naturally produced in the humam body simply because it has the backing of a government agency that works for big business?

Plix - Yes they are! When I read these reports by Doctors who think this test was some profound bit of R&D?? I really worry.... If we are not vocal they will have the feds shoving this horse urine iodicy down our craw! Err whatever body opening they like. Not sure where the Craw is!

And while I didn't know that IBPerv and I were not agreeing I'm happy we are at long last!

Hey, I know my promotion of male hormones strikes some as bad but I'm not (honest!) against men who wish to be hormone free Eunuchs. I'm very for it in a variety of cases. I just don't want it for "me" anymore.

[NaziNuts (imported)]

The FDA should crack down on crack, not on moaning whores, and especially not on hormones. Just one opinion.