Mirvaso has been approved by the FDA.

[arb161]

Re:the FDA

May I respectfully suggest other scenarios. That the FDA pays non competitive salaries, that do not attract the best candidates. That combined with furlough days and government shutdowns during whiich you have to find a way to feed your family, makes putting in some years and leaving for a job in the private sector that pays three times the money very attractive. The institutional memory of the close call with thalidomide will never be forgotten. More recently we saw the problem with compounding pharmacies (which were not under FDA oversite) where they gave contaminated medications to patients who later died or are still very sick. People always want to blame the guy at the bottom. But my experience is that tremendous pressure is put on agencies by companies who lobby(legal bribery) politicians to get what they want.

[nat007]

All taken into consideration though, isn't it a very sad state of affairs that close to a decade is spent on this Sansrosa/Mirvaso cream, which -like carmk700 wrote so well- has nothing innovative to it if you look closely at it and that the FDA gets paid a huge amount of money to control test it and neither Galderma nor the FDA noticed the rebound issues which maybe 95% of users so far here mentioned? (And I mean systematic rebound flaring, not the <10% side effects of flushing and redness in the control group). Sure they are a minority, sure they might be the worst of the bunch and the ones first to review things here, but nevertheless, this is no obscure side effect but the basic and predictable action mode of this drug. Its sad that the president of galderma gets hopes up high yet nobody thinks it mandatory to warn flushers for rebound flaring? Just a milking cow as the Dutch would call it.

I'm glad that this cream might work for those with uncomplicated baseline redness, but even for them there is a risk of rebound worsening and no excuse out of whatever book can change for me that its a huge disappointment that none of this was described by galderma in the product info.

[arb161]

Yes nat, you're absolutely right. But there is so much crap that goes on iin governmental agencys right now. It's very sad. They don't hire staff, and the ones that are left are probably close to, or should have retired years ago. They "contract out" tasks to people who work in the industry and have conflicts of interest. Industry staff have even been known to write the regulations. The pressure that's put on civil service staff by politics is rough. They can't fire you, but they can make your life miserable. Like transfer you to the equivalent iof Siberia doing a mind numbing task all day long. I'm not suggesting conspiracy because I really don't believe in that stuff, but I have seen it happen. The release of this drug- held up for years & then poof! suddenly it's released. Pretty questionable to me. I just felt that blame was being directed at people who are not responsible for policy.
Arlene

[nat007]

Yes Arb, well put. I agree that you can't blame such slips on the individual people working for the FDA. Like with every big company, its the chaps at the top usually. No doubt its a very special business section, and government and lobby boys have a hand in all sorts of things we don't know about. Anyway, lets hope that Mirvaso turns out to be a great cream for those with moderate redness and that these reviews here so far are within the 10% side effects and that we are all (most) here overreacting a little bit at the moment

[man_from_mars]

I don't know if this marketing campaign will backfire on them or not
but just noticed this new IOS app

The Mirvaso Mirror app
lets you document before-and-after photos

http://www.dailyappupdates.com/Details.aspx?id=722911190

[Makron]

Im from Sweden and I asked Galderma nordic about Mirvaso. This is what they said.


Mirvaso ® (brimonidine 0.5%) gel is a medicine since the end of August 2013, approved in the U.S. by the FDA (the Food and Drug Administration) for the treatment of rosacea. FDA is a hard investigative authority and accept no preparations that are considered somehow risking people's health. Mirvaso is a prescription drug always given on the prescription of the physician. All side effects are collected and recorded. Galderma has not received any significant amounts of reports that would suggest that the preparation does not meet the requirements it was approved under.

Sound reasonable to me. Perhaps you people have been to busy posting here that you forgot to report adverse effects ?

[Starlite]

I don't know if this marketing campaign will backfire on them or not
but just noticed this new IOS app

The Mirvaso Mirror app
lets you document before-and-after photos

http://www.dailyappupdates.com/Detai...x?id=722911190

Really? This could be a BIG problem for them. Somebody PLEASE up load a true and honest before and after pic. Please!

Im from Sweden and I asked Galderma nordic about Mirvaso. This is what they said.

Mirvaso ® (brimonidine 0.5%) gel is a medicine since the end of August 2013, approved in the U.S. by the FDA (the Food and Drug Administration) for the treatment of rosacea. FDA is a hard investigative authority and accept no preparations that are considered somehow risking people's health. Mirvaso is a prescription drug always given on the prescription of the physician. All side effects are collected and recorded. Galderma has not received any significant amounts of reports that would suggest that the preparation does not meet the requirements it was approved under.

Sound reasonable to me. Perhaps you people have been to busy posting here that you forgot to report adverse effects ?

I wonder what they would consider a "significant" amount? And.. yeah.. reports to the FDA are a daunting thing to do... I would love to hear if anyone did make an official report and how that went. I remember back on page...???... someone did file a report with Gal-Darn'a and they were treated well and got a full refund. No one has mentioned an FDA report yet.

[fluffhead]

Longtime reader, first-time poster

I unfortunately have to add to the sorrows of Mirvaso. I've been struggling with constant redness and pretty intense flushing for a while now, and it's been especially bad during the last few months. I really, really thought Mirvaso might help, but after my first 3 days of it, I've had some very ugly rebound flushing.

I think I'm going to try lasers. They seem to get much better reviews and seem to last longer. Best of luck to the rest of you trying this new stuff. I too, can't believe it got USDA approval with such a seemingly large number of reports of its problems.

[GreenGables]

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.

I am noticing this too. When I first started Mirvaso my face was only pale for about 6 hours. The last day or so I've noticed it stayed pale for almost 9 hours! I think it may be stopping further inflammation down the line. Not a cure, but for those who don't get the rebound flushing, it is a nice tool to have.

[man_from_mars]

Really? This could be a BIG problem for them. Somebody PLEASE up load a true and honest before and after pic. Please!

It is a real app - so have to commend them for trying to get feedback
Though it's Apple users only
-Android users never get Type 1 Rosacea with 'persistent' redness

Sounds like a good idea with the guided positioning and reminders through the day
Optional - share your pics with friends on facebook

================================================== ========
•Take a before photo, apply MIRVASO, and then go about your day
•Preset reminders prompt to come back to the app periodically to take another photo and see how MIRVASO is working for you
•Take up to 4 after photos within 12 hours
•Positioning of the after photo is guided by the before photo so all your pictures are the same size and position for optimal comparison
•Compare your before photo to the after photos you take within each session
•The app will save up to 30 sessions so you can come back and view them anytime
•Star your favorite sessions

Share
•Choose your favorite before-and-after photos and combine them into a single picture to share with friends and family via Facebook or email

================================================

[Starlite]

It is a real app - so have to commend them for trying to get feedback
Though it's Apple users only
-Android users never get Type 1 Rosacea with 'persistent' redness

Sounds like a good idea with the guided positioning and reminders through the day
Optional - share your pics with friends on facebook

================================================== ========
•Take a before photo, apply MIRVASO, and then go about your day
•Preset reminders prompt to come back to the app periodically to take another photo and see how MIRVASO is working for you
•Take up to 4 after photos within 12 hours
•Positioning of the after photo is guided by the before photo so all your pictures are the same size and position for optimal comparison
•Compare your before photo to the after photos you take within each session
•The app will save up to 30 sessions so you can come back and view them anytime
•Star your favorite sessions

Share
•Choose your favorite before-and-after photos and combine them into a single picture to share with friends and family via Facebook or email

================================================

You are too funny. This is a riot to me, this whole "app" thing... for a drug for goodness sakes. Thanks for sharing MfromM!

[man_from_mars]

You are too funny. This is a riot to me, this whole "app" thing... for a drug for goodness sakes. Thanks for sharing MfromM!

Well it wasn't all in jest Starlite - ofc can't understand why they couldn't also make an Android based Selfie App
(nobody really owns a Windows Phone)

but hopefully some people will use it for feedback to them (good or bad)
-mfm

[Joseph]

Mirvaso review from Julie Zuckerman.

https://www.nyccosmeticdermatology.com/mirvaso-review-redness-relief?utm_source=rss&utm_medium=total+social+solutions&utm_campaign=RSS

[roasceaclearwannabe]

Mirvaso review from Julie Zuckerman.

https://www.nyccosmeticdermatology.c...m_campaign=RSS

That is a terrible review, its basically the galderma drug description regurgitated! Reviews like that make side effects sound non-existent!

[Makron]

Put this one up on the positive mirvaso experience. "She says what galderma says". Why is everyone assuming that galderma and the FDA lies. Give the conspiracy theories a rest please unless you have som good evidence.