Mirvaso has been approved by the FDA.

[Birdie]

[ATTACH=CONFIG]2037[/ATTACH][ATTACH=CONFIG]2038[/ATTACH][ATTACH=CONFIG]2039[/ATTACH]


First time posting here. I was diagnosed with rosacea about two years ago- biggest symptoms were moderate to severe flushing and some growing, persistent redness. Tried a few topicals and minocycline over the past year without too much improvement. Had one IPL with really good results- going back for another round and anticipating about three to four total. Was given two Mirvaso samples by the derm. I've included three photos; one of my face while on mirvaso for the first time and two of the horrible rebound flushing I've had. I used mirvaso for two days and then was in class the next day and bam! Started to flush more badly than I ever have before in my life, beyond deep red all the way into purple. So painful and intense that I had to leave class and it took two hours to start going down. Didn't reapply mirvaso but the next day around the same time had another huge flushing episode where I had to leave class, so deep purple. As I walked to my car people were staring and talking under their breath about it. Pictures of rebound flushing are from today- day 3 of flushing intensely at the same time with no trigger, just out of the blue. 2 1/2 hrs later still waiting for sw improvement. I feel extremely sad and frustrated, almost hopeless. Three days ago, before mirvaso and a few weeks after IPL, I was still red but feeling happy, optimistic and like rosacea wasn't that big of a deal. This flushing is debilitating; not sure what to do anymore. Just thought I would add my experience here.

Whatisitworth, I'm so sorry this has happened; but I think you WILL be ok. Other posters who have tried
It seem to calm down within a week. Next time, if you decide to have another IPL, you might want to
Wait a little longer between treatments. Sensitive skin takes extra time to recover. Please take the time
To make a formal complaint about this product. To your doctor, Galderma, FDA. Also, did you try
The mirvaso after reading posts here or before? Thank you for sharing your story. As I said, I believe
You will recover from this mirvaso nightmare. Don't be hopeless. Best regards, birdie

[captcaveman]

I know its generally dissatisfied people who post reviews, but shouldn't we have seen at least 1 success story by now?! Just one?

The only happy success I read is from people during their first 1-3 applications.

Once the joy at seeing their true skin again (possibly the first time in years) passes, then its a trainwreck. Unpredictable horrible rebounds, all. Very discouraging.

Where are all those hundreds of clinical trial participants? Why don't they come forward anonymously and call out this fraud?
Surely they must have reported this Rebound effect during the trials.

[Mirvaso2013]

I know its generally dissatisfied people who post reviews, but shouldn't we have seen at least 1 success story by now?! Just one?

The only happy success I read is from people during their first 1-3 applications.

Once the joy at seeing their true skin again (possibly the first time in years) passes, then its a trainwreck. Unpredictable horrible rebounds, all. Very discouraging.

Where are all those hundreds of clinical trial participants? Why don't they come forward anonymously and call out this fraud?
Surely they must have reported this Rebound effect during the trials.

Agreed mate .

Can someone from the Trials please help us out here .

[Barbara]

Whatisitworth
thank you for your information. I'm feeling with you! My biggest problems is also moderate to severe flushing. I can almost feel the heat and pain on your face. I hope your face will settle down quickly. Using lots of thermal water in a can every 5-10 minutes for as long as needed always helps me to calm down a flush. Have you tried that?

Best wishes, Barbara

[hg24]

Hi all, I'm wondering if this entire thread can be shown to the FDA? Or maybe they need officially filled out reports? This just seems so tragiic to me I feel for those of you who've tried this. The recovery must be horrible and scary. You will be okay in time. But this shouldn't have ever happened.

[jaygee]

My reaction to Mirvaso

I'm a 24 year old male with persistent redness on cheeks and temples. I flush too. I use makeup to cover up the redness and that does an okay job. Anyways, I Got the drug a couple of weeks ago. I used pea sized amounts as directed on the first day and saw little change to my face if at all. Nothing like the "ghost" complexions that many people say they have experienced. The next day I tried putting more on and for whatever reason, this time the stuff worked well enough to notice a difference. Again, not "ghost-like" but a definite improvement. However, in about 5-6 hours the stuff wore off and the redness came back under my makeup which has never happened before. So I stopped using it for awhile. Now for the last week or so I have been using the very smallest amount, like hardly any but just a little on my face. I don't get any rebound, but to be honest I'm not sure if the results are there either. That's just the psychology of rosacea I think; it is sometimes difficult to know if something is actually working or not. I'm starting to try a non lactose diet for persistent redness, although if I take a step back, that sounds pretty dumb too... Lactose causing persistent redness???? Oh well

[Joseph]

Galderma USA president steps down

http://healthcare.dmagazine.com/2013/10/15/francois-fournier-out-as-galderma-u-s-a-president/

[Mirvaso2013]

Galderma USA president steps down

http://healthcare.dmagazine.com/2013...s-a-president/

Lying son of a bitch ... that's what he is

So the **** has hit the fan about Mirvaso .


And I see we got a mention in the article above

[maskielli]

Galderma USA president steps down

http://healthcare.dmagazine.com/2013...s-a-president/

This is good, basically Galderma realising that they messed up hard. Perhaps there might be more to come in the future.
http://www.cafepharma.com/boards/sho...d.php?t=541475 unoffical galderma worker forum im guessing thiswill blow up about the step down anytime and show the sales peoples perspective on Mirvaso

[Mirvaso2013]

Seems to be a bit of a "**** you" move. Launches what seems to be a completely flawed drug, mentions it a bunch of times in the article, steps down and lets the company deal with the mess.

Read the comment underneath the article

The brass neck of this company .

They are still in denial about the rebounding .

[Starlite]

Galderma USA president steps down

http://healthcare.dmagazine.com/2013...s-a-president/

WOW!! That's huge! This gets curiouser and curiouser. I'm sure he will be well taken care of for throwing himself on the grande. This is part of the revolving door in big pharma and politics, they move people around to protect and cover behinds.

[Vovin]

I just don't buy into the theory that Mirvaso was a known disaster and has been rushed through the FDA just to make money.

Still sticking with this?

[David Pascoe]

Still sticking with this?

At best what is being reported here are anecdotal reports - as disappointed as everyone who has had a bad reaction is, this sort of information gathering doesn't amount to real statistics from the general population.

Conspiracy theories are easy to write, very hard to prove. Much easier to imagine someone with a big wad of cash corruptly paying for approval than to understand what is really going on.

For the 1 year-long Phase III trial, 276 people used it once a day, and 220 of those had no adverse reaction. So to be any real comparison we need to hear from around 300 people here before the results can be as relevant.

So yes for now I think there is no information that Mirvaso was a known disaster and got through the FDA without due process.

[Starlite]

Still sticking with this?

Edit: Dang, Dave answered while I was posting. Never mind!

[David Pascoe]

Edit: Dang, Dave answered while I was posting. Never mind!

Don't tell me you were going to agree with me ;)

One more thing to realise as well, the trialists were clinically assessed as well as patient assessed. So their participation will have an idea of how well it is working or not by someone else who has the ability to confirm the results or bad reaction.

What if blushers should not use Mirvaso ? What if it is really is only for those with a permanent red face ? Galderma hasn't said that, but it is worth considering.