My nurse prescribed Estratest for a couple of reasons. I did a search on this stuff before deciding whether or not I wanted to use it.

Aside from the ethical sides of not wanting to take it (the manufacturer's cruel use of keeping mares pregnant so they can have hormone-rich urine as an ingredient) and the side-effects, I have opted not to fill the RX.

HOWEVER:

Imagine my surprise, when I found that it has NEVER been approved by the FDA!!

Even the manufacturer's own website admits that Estratest has not been FDA-approved.

The drug is NOT listed on the FDA website of approved drugs.

There are several lawsuits pending on this product regarding their engaging in false and illegal marketing of this drug. They certainly are making money on it, as in 2000, their sales of Estratest reached $110 MILLION!

So, you might want to think twice before you take this stuff. And, ask your doctor why they prescribe a drug NOT approved by the FDA (which, by the way, is illegal).

Just an FYI........

Hey saucy,

Fascinating info. Thanks very much for sharing it!

O.K., now for the “rest of the story.” This one is a little tangled, but stick with it…

In 1938 we got laws in the US requiring that drugs be shown to be safe by the FDA to be marketed.

In 1962 new laws were added requiring that drugs also be shown to be effective. This was also retroactive to previously approved drugs. Drugs that were approved prior to 1962 and were “identical, similar or related” to a drug that was found to be effective could get a “piggyback” approval.

In 1964 Estratest was first sold. It did not have FDA approval as required.

In 1972 the FDA found 5 estrogen+androgen drugs safe and effective for “menopausal syndrome in those patients not improved by estrogen alone.”

In late-1972 the company asked the FDA if Estratest could get approval as “identical, similar or related” to the 5 drugs above. The FDA’s reply is unknown, but since Estratest came on the market after 1962, it doesn’t meet the qualification for “piggyback” approval.

In 1976 the FDA again found the 5 effective but amended the labeling to read “moderate to severe vasomotor symptoms [hot flashes, night sweats] associated with the menopause not improved by estrogen alone.”

In 1979 the FDA wrote to the company telling them that Estratest was under legal review, and that no action relating to its approval would be taken.

In 1981 the FDA determined that Estratest might meet qualifications based on the 1976 findings, and the company filed an ANDA (Abbreviated New Drug Application) with the FDA.

In 2003 the FDA reviewed the available literature and found that there was a lack of substantial evidence that Estratest was more effective for vasomotor symptoms than estrogen alone. The FDA also reversed its 1972 and 1976 approvals of the 5 estogens+anrogens, but none of the 5 was still on the market. Here’s the full FDA docket, but I’ll warn you it’s a tough read: FDA Docket. And here’s the FDA’s Talk Paper from 2003: FDA Talk Paper. In it they say, “It has been FDA's long-standing policy to allow the continued marketing of drug products while matters such as these are being resolved, provided there is no documented serious public health or safety issue associated with such products.”

In December 2004 the safety data from Estratest, which is no worse than any other estrogen product, was used as back-up support for Proctor & Gamble’s application for the Intrinsa testosterone patch.

So here we are in 2005 and the FDA has not approved Estratest, nor have they removed it from the market. It’s been being used for 40 years and no one has found any safety problems with it. The FDA has determined it doesn’t work better for hot flashes than just estrogen, but no one has looked at the libido item. The FDA won’t review that claim until the company makes it. The FDA does hint at it in their 2003 Talk Paper, saying, “FDA encourages the development of clinically meaningful information about new uses of these combination products, including for the treatment of female sexual dysfunction.”

But for now Estratest is still in regulatory limbo.

-Margo

Whew! Margo - that took some research.

Thanks so much for clarifying something incredibly confusing!


Jacquie

...and now 4 years later our story may finally have an end. Solvay announced it has discontinued supplying Estratest and Estratest HS, and will not fill new orders after March 31, 2009. Drug still in the supply chain will continue to be sold.

-Ms. Margo

The FDA is fooling with Armour and Nature-Throid hormone too. I just got on the Armour 5 months ago and now I can't get any. They say the company has to file a New drug application, something like that, but the drug has been made and sold since like 1890 or something. I'm not sure why this is happening to this drug as it was made before the FDA even was created. But we can't get our meds.

What about compounded testosterone? I was using that but stopped. Can one still get that?

The reason this drug has did not get FDA approval, is not because of the estrogen made from horse urine but because of Methyltestosterone!
FDA does not approve any type of TESTOSTERONE for women, perhaps, in future, but not currently.
The estrogen part is not a problem, FDA has approved Premarin that made is from pregnant mare urine, so estrified estrogen part is not the problem.
The HRT is not a medication intended to cure any illness, it is consider SUPPLEMENTAL REMEDIES, so there are many options of BHRT that are also not approved by FDA.
Same goes for all compounded hormones, cream, sublinguals, pellets, etc. FDA never approved any formulation containing estriol either.
It is personal choice, I believe none of the vitamins or supplements is FDA approved as well, but ppl don't hesitate taking handfuls regardless of the approval.
I am not defending the manufacturer, I personally, won't use any non regulated or not FDA approved medications or supplements, but since it is not exactly, consider a drug, FDA sort of has no control over it.
Solvay Pharmaceuticals Inc. that manufactures Estratest, is registered pharmaceutical company http://www.solvaypharmaceuticals-us.com/pr...7223-2-0,00.htm
that also FDA approved Prometirum along with Estratest.
I would not worry about the quality of Estratest, it is a commercial product if one wants to use it for HRT.
The testosterone part prevents it from FDA approval.
HTH,
I.