Trimis is not FDA approved !!

[jackpTenn]

After finding out that the FDA had shut down Fast Size for not being FDA approved I was wondering abaout trimix.

If you have read my history you will see where I tried trimix for over a year and it made my condition worse by causing corporal fibrosis.

I remember in 2005 when I first started trying trimix I had to sign a relese that said trimix was not FDA approved. I sent a message to Todd Doran MS PA-C at Vanderbilt asking if trimix was now FDA approved.

This is his responce.

Jack

From: Doran, Todd James
Subject: RE: Trimix / Penile Injections
To: "Jack Pinner" <jwp104@att.net>
Date: Friday, August 27, 2010, 1:27 PM


No and never will be. Trimix is alprostadil, papverine, and phentolamine. Bimix is papaverine and phentolamine. Edex/caverject is alprostadil. Alprostadil is only FDA injectable approved for ED. Studies were done, commercial product etc so that's why. Other two are generic and used for decades so that's why no attention was given to make a commercial product and pursue FDA approval. That being said, alprostadil has less risk of penile scarring/curvature or priapism compared to other 2 formulations. The downside is that alprostadil has more penile pain/pelvic ache that is medicine/dose related not injection related. Alprostadil is our first line injectable.


Todd

Todd J. Doran, MS, PA-C
Associate in Urologic Surgery
Vanderbilt University
Dept of Urologic Surgery
A-1302 MCN
Nashville, TN 37232
615-322-2880

[fxd_tig]

I always wonder about drug combos... Scares me to try.

[regain-is-the-aim]

While I agree with jack's post on bi and tri- mix; I wanted to add a thought on FDA approval. As Todd Dornan of Vanderbilt observed, it will never be. I agree with Todd. It would be almost impossible for any company to go thru the process to gain an approval. Since these are "mixed" by a compounding pharmacy all over the country in many different % there is no viable way to run the "test" required by the FDA. But gentlemen, approval by the FDA is not an end-all. So far every med approved by the FDA has had a side-effect on some patients that can be very minor to an immediate jeopardy.

The mixes, which have been utilized for years, have- if you will- been "field tested" in probably millions of penile shafts many millions of times. Normally they work well for most guys- but some of us will have issues. The important point is to enter the area with a good doc who has experience and will test you and your reaction in the office and give you very good instructions. A good compounding pharmacy is also important and they, also, should be a resource for questions and assistance.

The compounding pharmacy in Indianapolis told me they have men on injections who have been injecting for more than 10 years who have had no issues. This is merely an additional tool to assist us when appropriate.

I just wanted to observe the FDA approval component of the post since it is not a guarantee. Granted it is an important safeguard where appropriate. But it is a very complicated, legalistic process that is hugely expensive that takes years to complete. On this as with so much of what we face with ED- TRUST your doc or get another doc you can trust and ask a lot of ?'s. And then, ask the ?'s again on this site as the experience represented here is probably deeper that most academic medical centers.

Just a thought and observation,


Dick

[Cajun Jeff]

Dick very well written responce to the fact of FDA approval. I know that many have used Tri-Mix and Bi-Mix with great success. As with any drug there are risk. We must be careful.

Cajun Jeff

[Techman52]

Dick very well written responce to the fact of FDA approval. I know that many have used Tri-Mix and Bi-Mix with great success. As with any drug there are risk. We must be careful.

Cajun Jeff

I start my journey down the "bimix" road tomorrow at 1:30. Wish me success

Larry

[jackpTenn]

Dick

I understand that a lot of men use trimix without any problems. I was one that had problems with scarring and corporal fibrosis from trying it for less than a year.

The point I wanted to make was. Be careful and watch for scarring or a sudden curve (peyronies). Scarring and/or peyronies will only make things worse. If this happens stop using it and get back to the doctor.

Jack