my care2
make a difference

community & fun

groups

get together & make a difference

 
 
LADIES ROOM (No Men Allowed) January 09, 2008 3:00 PM

We know you'll peek!

FDA cracks down on custom-made hormones

By RANDOLPH E. SCHMID, AP Science Writer 27 minutes ago

WASHINGTON - 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 use the lowest effective dose of hormone replacement drugs that it has approved for menopausal symptoms, and do so for the shortest time possible.

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."

FDA officials stressed that they are not cracking down on all forms of compounding. Traditional pharmacy compounding involves the combining or altering of ingredients by a pharmacist, in response to a doctor's prescription, to produce a drug tailored to an individual patient's special medical needs.

In addition, it said the term bioidentical has no accepted meaning.

Warning letters went to Panorama Compounding Pharmacy of Lake Balboa, Calif.; Saint John's Medical Plaza Pharmacy of Santa Monica, Calif.; Murray Avenue Apothecary of Pittsburgh; Village Compounding Pharmacy of Houston; Pharmacy Compounding Specialties of Dallas; Reed's Compounding Pharmacy of Tucson, Ariz.; and Pacifica Pharmacy of Torrance, Calif.

___

 [ send green star]
 
anonymous  January 09, 2008 3:10 PM

hmmmmm, I have been suffering for over four years now from a hormonal imbalance, after going completely vegetarian several months ago I have been looking and feeling much better. I think anyone who is considering hormone replacement, or hormone therapy should give a vegetarian diet at least six months before making the decision to take hormones if its within their power to do so...try it, its working for me.  [report anonymous abuse]
 
 January 09, 2008 3:59 PM

Very  interesting!

PS: true, we all know they'll peek! hehe ...

 [ send green star]
 
 January 09, 2008 4:00 PM

The natural progesterone cream has been working great for me for the past 10 years so I sure hope they don't succeed in getting that off the market.  [ send green star]
 
 January 09, 2008 4:13 PM

Good to know! Thank you, Donna!  [ send green star]
 
 January 09, 2008 4:37 PM

I am on natural HRT trouches, it is made by a compounding pharmacy. I was very ill, I am one of the extreme cases, yea, lucky me. Eventually I went to a natual doc who specialises in hormone related issues. And after 2 weeks the results were amazing, so amazing that my husband was telling anyone who would listen!
I am very careful about what I eat also as it does have a direct effect on how I feel, but I also have low thyroid, which surprisingly has improved since being on NHRT.

It's a no brainer, my doctor does blood tests, runs through everythng with me and makes adjustments to my medication based on my body.
If I go to a regular doctor he just gives me what ever he is pushing no blood test, nothing.

My doctor who was a regular doctor abotu 10 years ago still goes to some of the dinners put on by big pharma and he listens to other doctors tell him about their wonderful world trips paid for by big pharma. As he said they don't really see how corrupt they sound.

I signed a petition a couple of years ago, I think it was when there was talk of the government stopping this, but since then I have read many misleading articles in newspapers saying that compunding pharmacists are not safe. So the pharma PR people are out there doing their jobs to trying and save the HRT industry for wyeth!
 [ send green star]
 
anonymous  January 10, 2008 12:08 AM

Hi Donna, Elena, and Glenda,

This has been an eye opener so far. I am happy for your success with the natural compund Glenda, it would make all the sense that big companies would want to put a negative spin on any competition, but my goodness how much money do these big corps need! It makes no sense to me that the FDA could miss salmonella and ecoli outbreaks in food but they are right on top of this.

Is that wild yam Donna, or something else in the cream? My dear friend used wild yam for a long time and had great success with it.

Elena I hope you are doing good, I love your profile page. I think I told you before, I hate to repeat myself all the time, pass me some of those hormones!!!!!!!

 [report anonymous abuse]
 
 January 10, 2008 4:52 AM

My doctor is loved by all of us hormonally challenged patients and if you want to make an appointment it will take 6 months to get in as he is in such demand.
I think this says it all. The natural hormones work so well when you have a doctor who takes the time to understand the problem.
I was introduced to him as my niece has a chain of beauty salons and a very large percentage of her clients swear by him.

He explained to me the problem of why large pharma want's to stop it. Basically they are bio identical hormones. They are natural and they can't be patented so therefore there is no money to be made on a large scale.
The current issue is that it is not tested as such, and He said it is a little like a company selling water, it doesn't need to be tested unless they do something strange to it.
With the amount of women who stopped using regular HRT it has really impacted on their sales.
Wyeth used to make their HRT premarin from pregnant mares urine and that was cruel and disgusting, I have been told that this has been stopped.
 [ send green star]
 
Lill January 10, 2008 4:55 AM

There are several different kinds. The one from Wild Yam is good, however it's usually mixed with other things like aloe so it is a mild dose. Then there is pure progesterone which is stronger. Once I had run out of Wild Yam cream and none of the local stores had any. For some reason their distributors weren't bring it so I picked up some pure progesterone from a GNC where I usually don't go anymore as their products are so expensive and less quality than other Health Stores now IMO. Anyway, it worked well so I used it until the Wild Yam cream got back in the stock elsewhere. I find I have to use Wild Yam more often than the pure stuff though.

This post was modified from its original form on 10 Jan, 4:56  [ send green star]
 
Glenda January 10, 2008 5:08 AM

I hope you post information on your Doctor for our Australian members.

Here is the thread for that:

Naturopathic Doctors & Other Natural Healers

http://www.care2.com/c2c/groups/disc.html?gpp=10544&pst=823660&archival=&posts=17

 [ send green star]

 
 January 10, 2008 5:19 PM

 [ send green star]
 
 March 14, 2008 10:35 PM

International Authority on Natural Progesterone

John R. Lee, M.D. was an international authority and pioneer in the use of natural progesterone cream and natural hormone balance. He was a sought-after speaker, as well as a best-selling author and the editor-in-chief of a widely read newsletter.

His website offers a wide range of information about natural hormones and hormone balance for women and men, resources for finding out more, as well as a variety of books, audio and video tapes and other useful products. Read more about John R. Lee, M.D.

A Special Message To: All friends of John R. Lee, M.D.
From the Desk of: Mrs. John R. Lee.

http://www.johnleemd.com/

 [ send green star]
 
 April 07, 2008 7:00 PM

The DivaCup


Read on to learn more about
- The DivaCup® -
a menstrual revolution!


http://divacup.com/

 [ send green star]
 
anonymous  May 22, 2008 8:31 AM

Join the "I've Switched" Campaign
Please avoid using PMU drugs, there are alternatives
http://www.uan.org/index.cfm?navid=76
about Premarin
http://www.uan.org/index.cfm?navId=75

 [report anonymous abuse]
 
Re: Diva Cup May 22, 2008 9:33 AM

I use a combination of the diva cup and homemade cloth pads

 [ send green star]
 
 May 22, 2008 6:54 PM

thank you for the good info

 [ send green star]
 
Hot Flash Relief May 29, 2008 11:36 AM

With so many women entering the mid season of their lives this is invaluable information. Many are unaware of the side affects of HRT (hormone replacement therapy) which include, stroke, heart disease, and breast cancer.  

I know this may sound biased but the truth is that a great number of women have to wear many hats these days. I don't mean to exclude the men, in fact guys this information could be extremely beneficial to you. We know you're peeking ; )

The fact of the matter is many women are under a lot of stress having to be moms, housekeepers, income earners and even parental caretakers at the same time. No wonder we have mood swings and feel tired most of the time! Not to mention the hormonal changes we have to endure which include headaches, cramps, hot flashes and more.  Well, I've discovered an amazing natural product that I call women's little helper. You can try it for free. I've even had husbands call me to thank me for telling their wives about this. They said it saved their marriage!

You can learn all about it at; http://meno-relief.com

 [ send green star]
 
Ditch the tampons August 10, 2008 6:00 AM

After months of 'thinking about it' I finally purchased my own 'Mooncup'.
I have to say I am delighted with it and only wish I'd done it sooner.
http://www.mooncup.co.uk/

Ladies no more excuses, just do it!!

 [ send green star]
 
 August 10, 2008 12:58 PM

I never was into tampons, just the idea of it seemed irritating, never even tried it.

 [ send green star]
 
  New Topic              Back To Topics Read Code of Conduct

 

This group:
NATURE PROVIDES
1773 Members

View All Topics
New Topic

Track Topic
Mail Preferences


Copyright © 2009 Care2.com, inc. and its licensors. All rights reserved