Dutasteride not FDA approved

[BaldReaper]

Why is dutasteride not FDA approved?

[NARMAK]

Because the company that made it never applied for it to be FDA approved. 

Also, FDA approval isn't the be all and end all. It's approved by Japan and i believe South Korea. Its used "off label" in the UK and other places. 

It's funny to me how many people worldwide would seek to look at just the USA approval as a gold standard. Big Pharma has regularly been busted there for manipulated data and that includes Merk being in hot water for Finasteride with a lawsuit pending or underway for their original clinical trial data when they got approved. 

[follically challenged]

17 minutes ago, NARMAK said:

Because the company that made it never applied for it to be FDA approved. 

Also, FDA approval isn't the be all and end all. It's approved by Japan and i believe South Korea. Its used "off label" in the UK and other places. 

It's funny to me how many people worldwide would seek to look at just the USA approval as a gold standard. Big Pharma has regularly been busted there for manipulated data and that includes Merk being in hot water for Finasteride with a lawsuit pending or underway for their original clinical trial data when they got approved. 

Interesting. Valid point on looking to the US as a gold standard.

So what is the problem with Merk? 

[BaldDude]

It's approved, just not specifically for male pattern baldness.  Doctors can still prescribe it for it tho.

[Rahal Hair Transplant]

To be clear, dutasteride has been FDA approved for the treatment of Benign Prostatic Hyperplasia (BPH) or an enlarged prostate.   See https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm for more information.

So when someone is speaking about FDA approval, it should be discussed within the context of a particular condition. While dutasteride has been FDA approved for BPH, it has not been approved for the treatment of androgenetic alopecia (AGA) aka genetic hair loss.

But as already suggested, just because dutasteride hasn’t been tested and approved for the treatment of male pattern baldness doesn’t necessarily mean not an effective treatment.

When you compare dutasteride to finasteride, finasteride has proven to inhibit type 2 5-alpha reductase enzymes whereas to test drive has been proven to inhibit both type 1 and type 2 5-alpha reductase enzymes.  Both types facilitate the creation of DHT or dihydrotestosterone (The hormone responsible for carrying out genetic hair loss) when it combines with testosterone.

Since finasteride only inhibits one type of 5-alpha reductase enzymes, DHT is still produced using type 1.   As a result, dutasteride is clearly more potent than finasteride and has a better chance of slowing down, stopping reversing effects of male pattern baldness.

I always tell those considering medical treatment to first consider finasteride and then after a year, if they feel it’s not working, to try moving onto to test drive. It’s more potent which means it also has a greater potential for side effects.

I hope this helps 

Rahal Hair Transplant 

[NARMAK]

13 minutes ago, follically challenged said:

Interesting. Valid point on looking to the US as a gold standard.

So what is the problem with Merk? 

https://www.reuters.com/legal/litigation/group-sues-have-hair-loss-drug-propecia-pulled-market-2021-09-08/

This is what i could find on Google but basically it's that a small minority of people want it banned. We've already had a PFS discussion but unlike reasonable people on that thread, these people seem like complete zealots that don't care if it works for like 95%+ of people fine. They believe its the sole and only cause of their issues and want it banned for everybody. Bearing in mind if that happened, we wouldn't have any DHT blocking medication allowed. Possibly even in topical form because they'd go after Dutasteride next. 

[THE TRUTH]

Carrying out FDA clinicial trials is extremely expensive for a company. I don't think GlaxoKleinSmith will ever pursue getting FDA approval of Avodart for Androgenic Alopecia too. 

Also you have big players in this game, big pharma lobbies, pressure from other big companies... It's very complex. 

Ultimately most HT surgeons and even some dermatologists prescribe Dutasteride off label for hairloss. 

[NARMAK]

Just now, Unrealistic expectations said:

Carrying out FDA clinicial trials is extremely expensive for a company. I don't think GlaxoKleinSmith will ever pursue getting FDA approval of Avodart for Androgenic Alopecia too. 

Also you have big players in this game, big pharma lobbies, pressure from other big companies... It's very complex. 

Ultimately most HT surgeons and even some dermatologists prescribe Dutasteride off label for hairloss. 

I believe its also no longer patented and people can make generic versions of the drug cheaply so there's even less financial gain to be made. 

[Melvin- Admin]

2 hours ago, NARMAK said:

Because the company that made it never applied for it to be FDA approved. 

Also, FDA approval isn't the be all and end all. It's approved by Japan and i believe South Korea. Its used "off label" in the UK and other places. 

It's funny to me how many people worldwide would seek to look at just the USA approval as a gold standard. Big Pharma has regularly been busted there for manipulated data and that includes Merk being in hot water for Finasteride with a lawsuit pending or underway for their original clinical trial data when they got approved. 

Many on the board of big pharma companies worked for the FDA. There was a time when the FDA was respectable, but those days are gone. 

Here’s the honest truth. Avodart was created by gsk. They came up around the same time as Propecia. Propecia went through the FDA approval process first. This costs millions in research and testing. The initial plan that Merck had was to go the Rogaine route, once the patent expires sell it over the counter. You make much more being accessible over the counter. 

Unfortunately, they were sued, and that never came to fruition for obvious reasons. They didn’t make what they thought they were gonna make. In fact, the drug has become more of a liability to them. Had they never been approved for hair loss, they would’ve never been sued, because anyone who takes a drug off-label use is responsible for any side effects, including death. 

Gsk has no reason to go through the FDA approval for hair loss. They would get sued probably twice as much Merck, as it’s a much more powerful drug. There’s no pay out for them. When you get into the cosmetic world, your product better be uber safe, otherwise, it’s a big liability. 

[NARMAK]

1 hour ago, Melvin- Moderator said:

Many on the board of big pharma companies worked for the FDA. There was a time when the FDA was respectable, but those days are gone. 

Here’s the honest truth. Avodart was created by gsk. They came up around the same time as Propecia. Propecia went through the FDA approval process first. This costs millions in research and testing. The initial plan that Merck had was to go the Rogaine route, once the patent expires sell it over the counter. You make much more being accessible over the counter. 

Unfortunately, they were sued, and that never came to fruition for obvious reasons. They didn’t make what they thought they were gonna make. In fact, the drug has become more of a liability to them. Had they never been approved for hair loss, they would’ve never been sued, because anyone who takes a drug off-label use is responsible for any side effects, including death. 

Gsk has no reason to go through the FDA approval for hair loss. They would get sued probably twice as much Merck, as it’s a much more powerful drug. There’s no pay out for them. When you get into the cosmetic world, your product better be uber safe, otherwise, it’s a big liability. 

I think because Merk did get approval for it to be used as something to treat hair loss, that's why the lawsuits happened but i think you're right that GSK didn't have interest in going through similar so didn't apply. 

There's going to be future treatments hopefully approved within 10 years for hair loss but we need to await the full clinical trial results too. 

[drawdownfx]

1 hour ago, Melvin- Moderator said:

Many on the board of big pharma companies worked for the FDA. There was a time when the FDA was respectable, but those days are gone. 

Here’s the honest truth. Avodart was created by gsk. They came up around the same time as Propecia. Propecia went through the FDA approval process first. This costs millions in research and testing. The initial plan that Merck had was to go the Rogaine route, once the patent expires sell it over the counter. You make much more being accessible over the counter. 

Unfortunately, they were sued, and that never came to fruition for obvious reasons. They didn’t make what they thought they were gonna make. In fact, the drug has become more of a liability to them. Had they never been approved for hair loss, they would’ve never been sued, because anyone who takes a drug off-label use is responsible for any side effects, including death. 

Gsk has no reason to go through the FDA approval for hair loss. They would get sued probably twice as much Merck, as it’s a much more powerful drug. There’s no pay out for them. When you get into the cosmetic world, your product better be uber safe, otherwise, it’s a big liability. 

That was a very interesting read! 

[gillenator]

5 hours ago, Rahal Hair Transplant said:

To be clear, dutasteride has been FDA approved for the treatment of Benign Prostatic Hyperplasia (BPH) or an enlarged prostate.   See https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm for more information.

So when someone is speaking about FDA approval, it should be discussed within the context of a particular condition. While dutasteride has been FDA approved for BPH, it has not been approved for the treatment of androgenetic alopecia (AGA) aka genetic hair loss.

But as already suggested, just because dutasteride hasn’t been tested and approved for the treatment of male pattern baldness doesn’t necessarily mean not an effective treatment.

When you compare dutasteride to finasteride, finasteride has proven to inhibit type 2 5-alpha reductase enzymes whereas to test drive has been proven to inhibit both type 1 and type 2 5-alpha reductase enzymes.  Both types facilitate the creation of DHT or dihydrotestosterone (The hormone responsible for carrying out genetic hair loss) when it combines with testosterone.

Since finasteride only inhibits one type of 5-alpha reductase enzymes, DHT is still produced using type 1.   As a result, dutasteride is clearly more potent than finasteride and has a better chance of slowing down, stopping reversing effects of male pattern baldness.

I always tell those considering medical treatment to first consider finasteride and then after a year, if they feel it’s not working, to try moving onto to test drive. It’s more potent which means it also has a greater potential for side effects.

I hope this helps 

Rahal Hair Transplant 

Well said…accurately stated…even finasteride was initially developed for treating prostrate swelling in the form of Proscar (5mg)…some guys including myself, cut Proscar tablets into smaller pieces for treating MPB.

 

[Gregg H]

On 6/8/2022 at 8:30 AM, Rahal Hair Transplant said:

To be clear, dutasteride has been FDA approved for the treatment of Benign Prostatic Hyperplasia (BPH) or an enlarged prostate.   See https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm for more information.

So when someone is speaking about FDA approval, it should be discussed within the context of a particular condition. While dutasteride has been FDA approved for BPH, it has not been approved for the treatment of androgenetic alopecia (AGA) aka genetic hair loss.

But as already suggested, just because dutasteride hasn’t been tested and approved for the treatment of male pattern baldness doesn’t necessarily mean not an effective treatment.

When you compare dutasteride to finasteride, finasteride has proven to inhibit type 2 5-alpha reductase enzymes whereas to test drive has been proven to inhibit both type 1 and type 2 5-alpha reductase enzymes.  Both types facilitate the creation of DHT or dihydrotestosterone (The hormone responsible for carrying out genetic hair loss) when it combines with testosterone.

Since finasteride only inhibits one type of 5-alpha reductase enzymes, DHT is still produced using type 1.   As a result, dutasteride is clearly more potent than finasteride and has a better chance of slowing down, stopping reversing effects of male pattern baldness.

I always tell those considering medical treatment to first consider finasteride and then after a year, if they feel it’s not working, to try moving onto to test drive. It’s more potent which means it also has a greater potential for side effects.

I hope this helps 

Rahal Hair Transplant 

This confused me some. I thought dutasteride was used in place of  Oral minoxidil. 

This sounds like it's a replacement for  finasteride. 

Would you use Dutasteride and Oral Minoxidil together?

Or Dutasteride and Finasteride together? 

[Melvin- Admin]

14 hours ago, Gregg H said:

This confused me some. I thought dutasteride was used in place of  Oral minoxidil. 

This sounds like it's a replacement for  finasteride. 

Would you use Dutasteride and Oral Minoxidil together?

Or Dutasteride and Finasteride together? 

I use topical dutasteride and oral minoxidil in combination. My opinion, it’s the best stack. 

[Gregg H]

Could you recommend a place to get   topical dutasteride?