Mirvaso has been approved by the FDA.

[man_from_mars]

Before this thread gets out of hand and locked or someone gets banned - please keep your comments civil Mirvaso2013

Thanks,
-mfm

[arb161]

Thank you

Thank you so much man from mars.
Arlene

[hozer2k]

OK, lets not fight fire with fire. We are all on the same page here. It is a shame that this drug has done poorly for the forum members. That tends to ignite emotional responses. Ultimately, we all want what is best for rosaceans.

[roasceaclearwannabe]

I know this has already been discussed but have the users from this forum that experienced negative side effects with Mirvaso reported the issues to the FDA? If not please consider doing this as a matter of priority, as you could prevent other people further damaging their skin and making their Rosacea worse. I am not saying that this medication should not be on the market due to the poor results, as we all know that the forum only reaches out to a very small proportion of Rosacea sufferers. However I personally feel that more tests are required, as users that used brimonidine prior to its release in the form of Mirvaso experienced severe rebound flushing and still people using the official Mirvaso are experiencing these issues! On the other hand you could argue that people that have experienced a positive effect from Mirvaso may have no need to post/look on forums such as this.

[Mirvaso2013]

Here's the good news; Brimonidine, the main ingredient in this new cream, is extremely powerful. Tiny amounts of it turn my red red face absolutely pasty white. Because of that, it makes it much harder to flush.

Here's the bad news. I used Brimonidine successfully for several months in minute doses and loved it. Then my poor face exploded in a sort of steroid rosacea, in the way blood vessels explode with dilation after being forced to constrict for too long.

I'm horrified that Brimonidine got FDA approval when it clearly causes terrible rebound flushing.

In the early days when it working well for me, it caused horrible rebound redness that was much worse than the original problem in everybody who took my suggestion and tried it.

I think it took me longer to react badly because I was using such a tiny amount of it. Nonetheless, react badly I did and am still paying the price.

Hate to be the bearer of bad news but I urge tremendous caution with this dangerous, dangerous ingredient.

[alyfpet]

Will report, absolutely

I know this has already been discussed but have the users from this forum that experienced negative side effects with Mirvaso reported the issues to the FDA? If not please consider doing this as a matter of priority, as you could prevent other people further damaging their skin and making their Rosacea worse. I am not saying that this medication should not be on the market due to the poor results, as we all know that the forum only reaches out to a very small proportion of Rosacea sufferers. However I personally feel that more tests are required, as users that used brimonidine prior to its release in the form of Mirvaso experienced severe rebound flushing and still people using the official Mirvaso are experiencing these issues! On the other hand you could argue that people that have experienced a positive effect from Mirvaso may have no need to post/look on forums such as this.

I will absolutely be reporting this to the FDA. I am waiting to see my dermatologist a week from today to see whether it would be more appropriate (or hold more weight) for him to report it. There is no way he will look at me and not see the difference since I used it. My rosacea has been stable for 2.5 years, and now I'm a mess. It didn't seem to me that waiting to report would make a difference, since the FDA was essentially shut down anyway.

[Starlite]

I will absolutely be reporting this to the FDA. I am waiting to see my dermatologist a week from today to see whether it would be more appropriate (or hold more weight) for him to report it. There is no way he will look at me and not see the difference since I used it. My rosacea has been stable for 2.5 years, and now I'm a mess. It didn't seem to me that waiting to report would make a difference, since the FDA was essentially shut down anyway.

I am sorry you are going through this. I truly hope you make a full recovery or at least return to baseline. I do not mean to cause you any more stress or make you feel criticized by saying this. Also, I make this comment for the benefit of all who are finding themselves at the mercy of the medical system..

You are the consumer. The Doctor works for you. The FDA works for you. With out that mind set all actions and decisions are based on a "less then" state of mind as though the Doc was in charge. They are not. Please call the FDA with out the Docs permission. Then also have the Doc report it on your behalf.

[carmk700]

Really sad to hear these results about Mirvaso that some people are experiencing, and also a bit infuriated.

What I don't understand is how the active ingredient, Brimonodine, which is known to cause rebound flushing, could be approved as a treatment.
It could only have the same outcome as topical steroids- you have to keep using it and when you stop, you are much worse off than you started.
It makes for great before and after pictures and good short term results...I find it hard to believe that the bad reviews are just a small percentage of people, the mechanism by which it works sounds like a set-up for disaster. The total blanching of the skin, though cosmetically great for rosaceans, sounds in itself like an unhealthy process.

It's going to be interesting to see what happens next with this drug. Are people going to be able to prove that their condition was made worse with Mirvaso? After all, it is a progressive disorder, which is a convenient fact for the drug company...Things that make you go hmmmmm...

To all those who experienced adverse affects, I wish you a quick recovery back to your baseline.

[Mirvaso2013]

Really sad to hear these results about Mirvaso that some people are experiencing, and also a bit infuriated.

What I don't understand is how the active ingredient, Brimonodine, which is known to cause rebound flushing, could be approved as a treatment.It could only have the same outcome as topical steroids- you have to keep using it and when you stop, you are much worse off than you started.
It makes for great before and after pictures and good short term results...I find it hard to believe that the bad reviews are just a small percentage of people, the mechanism by which it works sounds like a set-up for disaster. The total blanching of the skin, though cosmetically great for rosaceans, sounds in itself like an unhealthy process.

It's going to be interesting to see what happens next with this drug. Are people going to be able to prove that their condition was made worse with Mirvaso? After all, it is a progressive disorder, which is a convenient fact for the drug company...Things that make you go hmmmmm...To all those who experienced adverse affects, I wish you a quick recovery back to your baseline.

Love your post mate .

[buratino29]

The thing is with brimonidine that it only fights consequencies of other up the line processes that actually cause inflammation.
I can say from my experience when experimenting with brimonidine, that after a few weeks on it, when I stopped using it, my face looked a lot better for next week or so.
Brimonidine has definitely got long term benefits of using it. But by no means it is a cure.

[roma59]

New member

After being a lurker for many years I've decided to chime in on this subject. First of all I want to thank the well meaning people for their suggestions on how to combat this condition. Have tried many of them but sadly none worked. This cost me alot of money but it seemed to be worth trying. Now after waiting many years for a so called "Miracle Drug" the results are to say the least dissappointing. Once again a product that is more hype than help. I sympathize with those who have tried mirvaso and the results were not only that it didn't work but has made things worse. I have not used it yet but have bought a tube of it. If it's any consolation to those of you that have posted with bad results you probably prevented others from the same fate and for that we thank you. Who's to blame? Gladerma yes. Shoved the product to the market probably for financial gain rather than to help people with this condition. Dispicable yes, but not surprizing. Then there's the FDA. They dropped the ball. I consider them the most responsible. They're supposed to stop companies from pushing drugs to the market to soon so the consumer will not be harmed. Maybe they thought that because no one will die from adverse reactions that it's ok to release it. If that is indeed their standard then they are doing the public a great injustice. I wonder what other drugs the FDA has approved that are now damaging the people that use them. The damage is not as obvious on some of these drugs as it is with mirvaso. It's more internal than external. Anyway that's my rant. Looking forward to posting in the future. Thanks.

[nat007]

Really sad to hear these results about Mirvaso that some people are experiencing, and also a bit infuriated.

What I don't understand is how the active ingredient, Brimonodine, which is known to cause rebound flushing, could be approved as a treatment.
It could only have the same outcome as topical steroids- you have to keep using it and when you stop, you are much worse off than you started.
It makes for great before and after pictures and good short term results...I find it hard to believe that the bad reviews are just a small percentage of people, the mechanism by which it works sounds like a set-up for disaster. The total blanching of the skin, though cosmetically great for rosaceans, sounds in itself like an unhealthy process.

It's going to be interesting to see what happens next with this drug. Are people going to be able to prove that their condition was made worse with Mirvaso? After all, it is a progressive disorder, which is a convenient fact for the drug company...Things that make you go hmmmmm...

To all those who experienced adverse affects, I wish you a quick recovery back to your baseline.

Yep, excellent summary.. I think its safe to say that brimonidine can be compared to steroids, in the way they suppress the existing inflammation and cause a rebound effect once you stop them. And most here know what havoc steroids can cause for people with rosacea in the long run. I know that I keep repeating this, but I just get so angry when you hear that doctors on the actual Mirvaso board have brought the rebound risk up and nobody seemed to care, or do anything about it. Just an outrage and indeed, it seems the short term improvement is enough for both galderma and the FDA to give it the green light.

If this product is aimed at very mild cases of stubborn redness fine. But at least WARN people with severe flushing (the subtype of rosaceans the director of Galderma openly aimed this product at in his interview) of the risks involved. None of that, no effort even to counteract the brimonidine rebound and it's beyond me how this stuff gets approved by the FDA without any warning at least about rebound. Grrrrrr

[GreenGables]

Ehh...I don't think increased FDA regulation will do any good.

Part of the reason new drugs are so expensive is because the FDA approval process can cost a company more than developing the drug in the first place. 800 million to get a drug "approved"? No wonder they charge $200 a tube.

I would rather try a drug and accept the risk that I may get side effects, than have some trained monkeys at the FDA take more of my tax money to tell me and my doctor what I can and cannot try. If you analyze how the FDA works, you may be surprised at how incompetent they really are. Giving those goons more power (and more pay) to legislate is not the answer.

I have had bad reactions to treatments before, so I do know where you're coming from, but...cutting off innovation / making it harder to innovate in the name of safety, usually just decreases innovation without decreasing risk. There will always, always, always be risks. I think we would do a lot better accepting those risks than trying to blame them on everyone who at least tries to solve a problem.

That said, the real reason I came onto this thread was to say I have been using Mirvaso for 3 weeks without any rebound flushing. Of course it all could change at some point, but so far it has worked for me. I posted more details in this other thread.

[carmk700]

Ehh...I don't think increased FDA regulation will do any good.

Part of the reason new drugs are so expensive is because the FDA approval process can cost a company more than developing the drug in the first place. 800 million to get a drug "approved"? No wonder they charge $200 a tube.

I would rather try a drug and accept the risk that I may get side effects, than have some trained monkeys at the FDA take more of my tax money to tell me and my doctor what I can and cannot try. If you analyze how the FDA works, you may be surprised at how incompetent they really are. Giving those goons more power (and more pay) to legislate is not the answer.

I don't think anyone here suggested giving the FDA more power and pay to legislate...we only are wondering how a drug was approved that could potentially make a condition worse, without at the very least stating a warning with the release of the drug. I don't claim to know the inner workings of the FDA drug approval process and can't vouch for whether they are all "goons" or not, but we do need a regulatory agency and a process to ensure the safety of drugs and that the side effects are not dangerous/and/or worse than the initial problem. I personally would rather not try a drug and accept that there's a good chance I'll experience side effects worse than the initial problem and that the drug doesn't even resolve the initial problem. But does it sound like the FDA needs an overhaul? Yes, it most certainly does.

I have had bad reactions to treatments before, so I do know where you're coming from, but...cutting off innovation / making it harder to innovate in the name of safety, usually just decreases innovation without decreasing risk. There will always, always, always be risks. I think we would do a lot better accepting those risks than trying to blame them on everyone who at least tries to solve a problem.

Where was the innovation with this drug? I don't see where Galderma innovated or even tried to solve a problem. They took a known drug, Bromonidine, which has a known rebound effect, put it into a topical, didn't address the rebound issue, and and are marketing it to be prescribed as a treatment for rosacea. And Mirvaso isn't a treatment in the traditional sense that it's actually healing anything, using it only causes a temporary cosmetic improvement. The danger in this is that people are getting prescribed this medication from their derm and think that their rosacea will get better, not worse. You may be willing to take that risk, but many others are not. I also don't think innovation and safety have to be mutually exclusive.

That said, the real reason I came onto this thread was to say I have been using Mirvaso for 3 weeks without any rebound flushing. Of course it all could change at some point, but so far it has worked for me. I posted more details in this other thread.

I am really glad to hear you're having success with Mirvaso and I am hoping that there are more people like you having a good experience. Please keep posting and continue to let us know how you're getting along.

[johnabetts]

Where was the innovation with this drug? I don't see where Galderma innovated or even tried to solve a problem. They took a known drug, Bromonidine, which has a known rebound effect, put it into a topical, didn't address the rebound issue, and and are marketing it to be prescribed as a treatment for rosacea. And Mirvaso isn't a treatment in the traditional sense that it's actually healing anything, using it only causes a temporary cosmetic improvement. The danger in this is that people are getting prescribed this medication from their derm and think that their rosacea will get better, not worse. You may be willing to take that risk, but many others are not. I also don't think innovation and safety have to be mutually exclusive.

The earliest filing date for a brimonidine/rosacea patent I can find was in 2004. Obviously investigative work had been carried out for some time before this.

My respect for the scientists at Galderma has plummeted. It must also remembered that Allergan, and possibly others are looking at the same material as well.