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Author Topic: Trimix injections for Erectile Dysfunction are not FDA approved !!  (Read 26493 times)

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jackp

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After reading about the FDA and Fast Size I wanted to see if trimix was FDA approved as a penile injection for Erectile Dysfunction.

I sent a message to Todd Doran PA-C at Vanderbilt. This is his responce.

Jackp

From: Doran, Todd James
Subject: RE: Trimix / Penile Injections
To: "Jack Pinner" <[email protected]>
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 Erectile Dysfunction. 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
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markwilson

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #1 on: September 01, 2010, 03:16:25 AM »

Trimix injections is not approved by the FDA.
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jackp

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #2 on: September 01, 2010, 10:19:15 PM »

Old Man

Trimix injection are not FDA approved for any reason.

The only FDA approved injectable for Erectile Dysfunction is PGE1, (carverject or edex.)

Jackp
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angelinadiaz

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #3 on: September 23, 2010, 03:32:07 AM »

Yes,Trimix injections is not approved by the FDA.Use only FDA approved medicines which gives good quality medicines.
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james1947

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #4 on: June 18, 2012, 07:05:30 PM »

Yes, Trimix is not FDA approved now also, almost two years after the last post on this forum.

My questions are:
If not FDA approved, why many uro's are prescribing it?
Is the injections of Trimix or other Erectile Dysfunction injections really make Peyronies? I read that some people using it for more than 15 years 3 times a week.
Have some forum members (people with Peyronies) that are using Erectile Dysfunction injections?

James
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jackp

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #5 on: June 19, 2012, 11:23:08 AM »

James

Urologist are writing prescriptions for trimix that can only be filled at a compounding pharmacy in the US. Each medication is approved for different reasons but the PGE1 (Carverject/Edex) is the only one approved for Erectile Dysfunction and available through a regular pharmacy, with a prescription.

Most men that use just PGE1, in a sufficient amount to produce an erection, experience pain from it. My understanding is that is why trimix was developed.

Yes, the prescribing information in Carverject/Edex  says it can cause peyronies. I can not quote it now it has been too many years since I used it. It also causes corporal fibrosis that is why most men that try in stop in less than a year. There are some that can use it for many years, we are all different.

The corporal fibrosis from penile injections caused my condition to get worse. That is one reason the first urologist, that tried to put in an implant for me, punctured my urethra.

Jackp
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james1947

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #6 on: June 19, 2012, 11:58:25 AM »

Jackp

Thank you for the answer, it makes me things more clear. I was just wandering regarding this subject.
If this is the case with Trimix, I will not trust any pharmacist here where I am living.

James
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #7 on: June 21, 2012, 02:29:01 PM »

So sketchy! :-X
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #8 on: September 27, 2013, 02:39:02 PM »

http://trimixgel.com/Erectile Dysfunction-erectile-dystfunction-medication/

Can this really work?
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jackp

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #9 on: September 27, 2013, 09:27:41 PM »

snowy

Trimix gel is also a compounded drug. The insert is vague about how it is applied. Way down in the insert it recommends use with a condom, in a lot of cases.

Like injectable Trimix it is not FDA approved.

Jackp
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koolx

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #10 on: October 14, 2013, 05:29:47 PM »

i dont understand.. if trimix injections are not FDA approved then why do docs prescribe it?
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MattFoley

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #11 on: October 14, 2013, 06:06:32 PM »

Just like Pentox is not FDA approved for Peyronie's, TriMix is used for off-label purposes.
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jackp

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #12 on: October 14, 2013, 06:48:08 PM »

koolx

Trimix is a mixture of 3 drugs put together by a compounding pharmacy. It is prescribed off label.

Jackp
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koolx

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #13 on: October 15, 2013, 07:32:24 PM »

thanks matt and jack.. but i strongly think that uros should wanr their patients that trimix is NOT FDA approved. i think its a sham.
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Hawk

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #14 on: November 18, 2013, 07:18:07 AM »

I know this discussion is a month old but it is a topic near and dear to my heart.  I was prescribed tri-mix injections by Dr. Mulhall and took the injections at least twice a week for 8 months (after prostate surgery).  At first I thought it was a miracle drug.  I felt I could take them for life.  The erections were great.  I could make the erection last even after climax. The cause little to no pain.  Fast working within 15 minutes of injection.  A single guy could use them and his date would never know.

THE DOWN SIDE -  As mentioned, tri-mix is not only no FDA approved, it is not a manufactured drug.  It is 3 drugs mixed together by a compounding pharmacy.  As such it is not even regulated by state laws and the manufacture of any of the individual drugs are not liable for any issues because they do not produce or market the drug to be compounded with other drugs.

One of the drugs in particular (Papaverine) has a warning that it can cause fibrosis.  I developed fibrosis that displayed all the normal signs of Peyronies Disease from these injections.  It began at the injection site.  In fact I once had trouble injecting because of scar tissue and was told by his nurse "never inject into scar tissue".  This means they knew I had car tissue and were very nonchalant about it.  I was ignorant and figured they knew what they were doing at the time.

Dr. Mulhall, totaly brushed off my printouts indicating that Papaverine can cause fibrosis.  He said my Peyronies Disease was caused by prostate surgery or that it would have happened anyway.  He told me to continue injecting.  I refused.
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Old Man

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #15 on: November 18, 2013, 02:58:31 PM »

Hawk:

I can echo your statements about penile injections in your post below. My uro put me on them for about 2 months after my radical prostate cancer surgery in April 1995. Every shot that I took gave me a great erection, very little pain on injection with very little side effects for a while. Then all of a sudden nodules starting appearing at each injections site when using the Tri-mix. So, the injections were discontinued, but Peyronies Disease symptoms just kept coming on with curves and bends along with hourglass effect at the old injection sites.

Somewhere around the same time, the uro put me on Verapamil injections with hopes of reducing the Peyronies Disease effects. Altogether, I took 12 of the Verapamil injections and again each one gave me more Peyronies Disease symptoms. Needless to say all injections into my penis was discontinued.

At the same time of the above episodes of Erectile Dysfunction and efforts to combat them, MUSE was prescribed for me. MUSE is an acronym meaning Male Urethral Suppository for Erections. The final result of those little pills that had to be injected into the urethra caused much problems with a severe burning sensation of the penis, irritation of the urethra and prolonged erections. After the erections subsided, there was significant pain for several days.

All of the above statements are related to a medium to severe case of Peyronies Disease that developed after a radical prostatectomy as stated above. My uro was very concerned about my Erectile Dysfunction and Peyronies Disease problems and then prescribed the old Osbon Erecaid Classic VED which was used to help eliminate the Peyronies Disease symptoms. Later, the Osbon Company gave me a discounted price for the Erecaid Esteem VED.  By using these VEDs, I was able to get rid of my Peyronies Disease in about a year of daily use.

I still use a VED for erections at my present age of 84 I am happy to say!! All I need to do is get the wife of over 50 to consent!!!!

The above information is posted in hopes that it will help others considering using injections to make a better decision for getting them.

Old Man
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chaszz

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #16 on: November 25, 2013, 02:21:26 AM »

I don't have Peyronies disease but have a history of Erectile Dysfunction. I've been using trimix for about 8 years as prescribed by several urologists in the New York City region. Although not recognized by the FDA there are a lot of men using it according to my urologist. It has worked pretty well for me. The erection arrives in 5 - 10 minutes and is dependable, and stays up after sex is finished. I take Sudafed to return the penis to the flaccid state when I feel like it.

Lately (I am now 72) the pain from the one ingredient mentioned as painful, in the first post in this thread, has been increasing. The poster at the bottom (beginning) of the thread, a urologic surgeon, calls this ingredient alprostadil. My compounding pharmacist calls it prostaglandin. I have found that compounding pharmacists generally know more about what will work than urologists, and the urologists look to them for advice on the proportions of the 3 ingredients to be used in the final compound. I know this sounds like alchemy, but the resultant formulas and adjustments have worked well for me for years. The compounding pharmacists have been responsible professionals, and I have only shopped around among them to get better prices. A dose comes to about $10. There can be large differences in what one compounding pharmacy will charge compared with another. I have read that PGE1 (Carverject/Edex) has quite painful side effects.

Now that the prostaglandin is starting to hurt too much, I have had it reduced and the resultant mix has not been working as well, so I have had to increase the dose. I am now at the maximum dose of 70 units and still experiencing pain, especially after intercourse, so have decided on a penile implant. But the trimix worked for years for me. I have some internal scarring, areas to avoid injecting, but not much. There are also injection aids such as the BD Autoinjector which make the injection easier. I have sometimes had trouble reaching climax with trimix and am hoping the penile implant will not have that problem. However, I think trimix is a possibility for relatively good results for many men with Erectile Dysfunction who do not want the more drastic choice of an implant. I have never tried the VED because the urologists I have spoken with do not think it is effective. I see one poster here likes it. Are there any others who've had good results with it?   

So I am not saying trimix is for everybody; just wanted to relate my experience which runs counter to the bad press the compound has been getting in this thread. The posts were focused mainly on the lack of FDA approval, but nobody with a positive trimix experience had replied, so I thought I should. For people like us, anything that may work well should get a fair shake in the thread, as some men may be helped by it.
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MattFoley

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #17 on: November 26, 2013, 11:21:47 AM »

I use Quadmix and I'm happy with it. But it takes me a long time to climax when I'm using it.
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james1947

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #18 on: November 26, 2013, 04:48:47 PM »

Thanks for your post chaszz, it gives a clear picture regarding the usage of Trimix from your experience.
I would like to mention that most forum members don't have nothing against Trimix, we do discourage strongly injecting to the penis for people that have Peyronies because of the plaques that are generated following injections.

James
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fred_hill

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #19 on: December 11, 2013, 09:37:42 AM »

I don't understand why doctors prescribe not FDA approved products...

I'm happy Viagra works well for my Erectile Dysfunction problem and don't need any other harmful or costly method...
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #20 on: December 11, 2013, 05:04:50 PM »

fred_hill,

Many drugs are used for off-label purposes, including Pentox. Pentox is not indicated for Peyronie's but urologists will prescribe it because clinical data supports some benefit for Peyronie's.

As for TriMix or QuadMix, I use QuadMix because I have bad Erectile Dysfunction from scarring and neither Viagra or Cialis give enough benefit to help me. Quadmix, coupled with a constriction ring, gives me the solid erection that I need for sex.
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james1947

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #21 on: December 15, 2013, 04:50:41 PM »

Matt, you are here already so maybe doesn't matter.
The main issue with injection to the penis that many of them (most of them maybe?) ending up here or on other Peyronies forum.

James
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MattFoley

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #22 on: December 15, 2013, 05:35:20 PM »

James, I only started doing the injections after Peyronie's. For whatever reason, my penis has no problem with injections, meaning that there is no further damage being sustained. Which also may indicate that we are susceptible to Peyronie's in different ways. One action that may cause Peyronie's in one person may not do the so in another person.
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james1947

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #23 on: December 15, 2013, 07:56:07 PM »

I agree with you Matt that Peyronies is a very individual disease, what causes Peyronies for one will not cause for others, what is a good medication for one, is not a guaranty it will work for someone else :)

James
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #24 on: December 16, 2013, 12:01:10 PM »

James, could you imagine if they put this warning on the outside of a pack of cigarettes:

"Warning: May cause your penis to be permanently bent & Erectile Dysfunction".

I'm guessing every guy in the country would stop smoking.  ;)
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james1947

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #25 on: December 17, 2013, 08:24:56 PM »

I don't thing it will make people to quit smoking.
In many countries, including where I am living now is written with big black letters that:
Smoking causing cancer, hearth problems and impotence
It is not driving no one to stop smoking, including the many foreigners living here :(

James
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hatlessacorn

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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #26 on: August 02, 2014, 03:35:50 PM »

(I don't have peyronies, but I have had serious Erectile Dysfunction for many years.)

It is true that Trimix has not been approved by the FDA for use in treating erectile dysfunction. However, it is important to understand that this in itself does not indicate anything at all about either the safety or effectiveness of using trimix for this purpose. Almost every drug that the FDA has approved as safe and effective treatment of one or another sort of medical problem also comprises safe and effective treatment for others. However, while drugs sometimes receive FDA approval later for some other use than the one for which they were initially approved, this often doesn't happen, merely for economic reasons: The expensive clinical trials which need to be run in order to obtain FDA approval for a particular use of a given drug are usually funded by drug companies, which will not find this feasible to do unless they can patent either the drug or the extraction method needed for its commercial production--patents which are often not possible for them to obtain since it is not possible to patent a drug that occurs naturally, or to patent a drug or an extraction method which is already in the public domain.

In any event, each of the three drugs which Trimix comprises (papaverine, phentolamine, and prostaglandin E1--which is also called alprostadil) is an approved drug, and one of them, alprostadil, has received FDA approval for use by itself in treating Erectile Dysfunction--although it isn't nearly as effective when it is used for this by itself. In any event, Trimix has been prescribed since the 1980s for Erectile Dysfunction, it has a good safety profile when used correctly, and it is often very effective in treating Erectile Dysfunction which has not responded well to any other treatment. The fact that Trimix has not (at least, not yet) received FDA approval for use in treating Erectile Dysfunction has no bearing on how safe or how effective Trimix is, on how appropriate it is for a doctor to prescribe trimix for this purpose, or on how appropriate it is for someone to use it to treat his Erectile Dysfunction. Trimix is the only treatment for Erectile Dysfunction that is effective for some men, including me. While the use of trimix is associated with a small risk of negative consequences, this is true of every medication--and I myself haven't experienced any significant problems at all from using it.
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #27 on: January 29, 2015, 01:11:23 PM »

Hey guys, I'm not sure where to ask this question, but here it goes. Those of you who know me on the forum know that I just had my 5 year anniversary from prostate cancer surgery and about 3 years having peyronies. I have had Erectile Dysfunction since the surgery and only can have sex using the VED. Today I had my first injection of Caverjet to produce an erection. I know it is contraversial for we with peyronies, but I'm tired of the rings. FT posted the way to get the best results, is to pump up first and then inject with a ring on. Any experience or comments would be appreciated. Regards Inkhorn
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #28 on: January 29, 2015, 04:30:40 PM »

Inkhorn

I don't think that you will get too much (if at all) on the subject here.
You will get much more on FT, as the site is dedicated to Erectile Dysfunction.
Some people got Peyronies from those injections, this is the reason is not so popular here.

James
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #29 on: February 23, 2015, 05:47:26 AM »

You may have non surgical treatment instead of surgical treatment to cure male impotence. You can have Generic Viagra, Cialis and Levitra that allow you to maintain erections.
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #30 on: February 23, 2015, 06:08:30 AM »

Paco

I understand from your two posts that you are a big fun of oral Erectile Dysfunction medications. Can you give us some information regarding your connection to Peyronies/Erectile Dysfunction?

James
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #31 on: February 08, 2016, 09:32:28 PM »

Hi: I had prostate surgery in 2007, and a year later started using trimix #1. Soon after, I developed a downward turn and later the hour-glass shape near the middle area. I was not injecting in this area. I talked to uro. and he said it was more than likely caused by the surgery and not the trimix. I continued injecting about twice per week, and within the next six months, both conditions had gone away and I was normal again, and have had no further problems with either. 
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Re: Trimix injections for Erectile Dysfunction are not FDA approved !!
« Reply #32 on: February 09, 2016, 10:02:40 PM »

railroadmack

Good to hear that you had no problems from Trimix injections, opposite can say. :)
Many others around here where not so lucky as they Peyronies started from injections to the penis.

James
Logged
Age 71, Peyronies from Jan 2009 following penis fracture during sex. Severe Erectile Dysfunction.
Lost 2" length and a lot of girth. Late start, still VED, Cialis & Pentox helped. Prostate surgery 2014.
Got amazing support on the forum
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