Will I have a Bad Reaction to Mirvaso?

Written by on September 2, 2013 in clinical trials, Mirvaso Gel (Brimonidine 0.33%) with 10 Comments

Now that Mirvaso has been officially approved by the FDA, the final clinical trial results quoted to the FDA have become available.

The Mirvaso Prescribing Information contains some statistics relating to the number and type of adverse reactions that occurred during the clinical trials.

So if you are prescribed Mirvaso, what are your chances that you might have some kind of adverse reaction?

Before we get to the official bad reaction figures it is worth looking at the experience of some people who have attempted to jump the gun on Mirvaso and tried their own Brimonidine Tartrate formulations. See Sansrosa delayed, sufferers make their own Brimonidine, BEWARE for a few sobering stories.

Mirvaso 29 Days Usage

The first data mentioned in the PI are the 330 Trialists who used Mirvaso Gel once a day for 29 days. These trialists had the following adverse reactions.

 

mirvaso-29-days-adverse-reactions

So you can see most users experienced no reaction, with 4% experiencing redness, 3% flushing, 2% burning, and from there.

Mirvaso 365 Days Usage

A total of 276 trialists used Mirvaso Gel once a day for a year. The adverse events experienced were ;

 

mirvaso-365-days-adverse-reactions

You can deduce from this that around 10% of trialists experienced flushing, 8% redness, 5% rosacea and 5% nasophyaryngitis (cold like symptoms).

Contact Dermatitis

Around 1% of the over 1000 total trialists experienced contact dermatitis. Two of these underwent further sensitivity testing and 1 was found to be sensitive to brimonidine tartrate and 1 sensitive to the preservative phenoyxethanol.

Chance of an Adverse Reaction

If you infer the same reaction rate in the general population, as the clinical trials you can expect around a 10% chance of having some kind of adverse reaction.

Whether or not this reaction will cause you to cease using Mirvaso of course remains to be seen.

It will be especially disappointing for those users who experience redness or flushing considering that the main benefit of Mirvaso is the reduction in these symptoms.

Summing it up

Amongst those who used Mirvaso for a month, just 4% experienced redness, and 3% flushing.

Amongst the 365 days trialists, 8% experienced redness and 5% had `rosacea’ as an adverse event and 5% cold like symptoms.

So overall your likelihood of an adverse event is low.

Good News Overall

The vast majority of users will experience no adverse reaction. This is good news and means you can be confident that you will see a benefit from using this new treatment.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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10 Reader Comments

  1. Sandy says:

    This is my second comment that I have written. This is my third month using Mirvaso. The longer I use the more I having good results. My recent visit to my dermatologist I asked her if there was a make up that could help me cover up the redness if it started up. She indicated that I needed a green base makeup. I called Macy’s Department Store and contacted the Clinque Makeup Department. Sure enough they had a green based makeup for Rosacea. It was called “Red Solutions”. It works great. If I applied the makeup early in the day and then decide to go out in public I keep the makeup in my purse and then I can reapply if I have to. It was a small investment to help my problem with Rosacea. It cost $29.00, plus sales tax. It’s worth a try. Let me know how you make out.

  2. GG says:

    Hi Sandy. Thanks for sharing the red solutions makeup. I use Clinique myself, and am so disgusted with the redness that mirvaso causes. I have only been on it for 2 weeks, and don’t use it every day because my rosacea gets worse when I use it.

  3. mapachon alegre says:

    a mi no me ha funcionado produce flushing y efecto rebote con rojez intensa

  4. Mimi says:

    I had horrible rebound flushing with Mirvaso. I was very disappointed. It took a couple weeks for my flushing to subside back to normal. I have had Rosacea for the last 15 years. I use Metrolotion and take 100 mg of Doxy a day. I was hoping the Mirvaso would calm down my mild redness. But it just made it worse. I have moderate Rosacea with ruddy cheeks (sometimes) and bumps. My normal med routine has kept it in check for the most part. I did get a full refund on my copay. 🙂

  5. Nancy says:

    I would like to see some longer term studies. I know with me, before Mirvaso came to the public, my Dermatologist suggested I use the Brimonodine eye drops on my face. I found it worked but that over time I needed more frequent applications before my face started to blush. It was suttle but the Brimonidine made my rosacea worse with continued use. The blushing and redness in my face was more extreme. I became very dependent on the drops to keep me from blushing badly. I did not change anything other than using the Brimonodine eye drops on my rosacea so I new that was the cause. I stopped using the medication on my face and it gradually calmed back down again. When Mirvaso finally came to the market I stayed away from it.

  6. Jeff says:

    I have had rosacea since I have been 10 years old. I am now 30. It has crippled me through out my life. I was constantly avoiding “triggers” I couldn’t drink coffee, alcohol, work out, and I avoided many social situations because I flush so easily that my face burns and I couldn’t take the looks and comments. Around 5 years ago I found a dermatologist and I started laser treatments and metro cream. Over the past 5 years my rosacea started to calm down and my triggers were affecting me less and less. I still had a noticeable redness but it was very mild and only on rare occasions would it flush to the point of stinging and burning. Recently my dermatologist told about a new product that was a god send for rosacea sufferers. Onreltea. I quickly got my prescription filled, paid the $150 for the small tube and raced home to apply this new product to my cheeks. I stared in the mirror for an hour and watched as the face I had always wanted began to appear. I was so happy! I finally felt comfortable in my own skin, there were no stairs or looks or comments. I was applying ONRELTEA in the morning at 8am and in the evening at 8pm. I looked a little pale almost vampire like, but I didn’t care I wasn’t a radish flushing if someone made a comment to me. It was the fourth day of application and I had invited some guests over for dinner. I was mingling in the kitchen talking with a new confidence that I had never felt before when I started to feel pin like pricks in my cheeks. Within 15 mins I started to notice conversations around me getting quiet and people were looking at me with a look in they’re eyes I knew all too well. I casually sneaked away to the washroom and glanced in the mirror. I couldn’t believe what I was seeing. I thought I was in a nightmare. My cheeks were not only red, my entire face was red and purple and blotchy with small blemishes quarter size resembling a port wine stain. I felt sick to my stomach. A wave of emotions flew through me. I was angry, sad, and embarrassed. I just wanted to disappear and not have to face the crowd that I knew was all waiting to see my face again. When I walked back into the kitchen every person stopped and looked at me and looked away. I didn’t want everyone to feel uncomfortable so I made light of the situation and announced that I was having a bad reaction to a new cream my dr gave me. I awkwardly struggled through the evening and was counting the seconds until I could disappear into a dark corner and not be seen. Its now been 8 days since I applied ONRELTEA to my skin and my face is now entirely red at all times. Its no longer just flushing of the cheeks, its my cheeks, my nose, my chin, and even down to the sides of my neck. My triggers don’t just make me flush anymore, they produce a multitude of shades of red with very blotchy regions. I wish I had never applied that awful gel to my face. It made a bareable condition into a nightmare. I am so tired of looking this way…

    • Konstantinos says:

      Hello Jeff. Really sorry that you had such a bad reaction. Something similar happened to me while at work, on a very important meeting day. I wanted to cry, to kill myself, to rip my face apart, and I too gave the same excuse to the people that I was meeting (a cream that caused my an allergic reaction was my excuse to them). I really, really, really hate Mirvaso, it’s an awful drug. Where you able to get back to your baseline pre-Mirvaso redness after all? Did your face returned to its “normal” state? And (hopefully it did) how long did it took you to return to “normal”? Thanks a lot in advance for your feedback.

      • Jeff says:

        Hello Konstantinos.

        I know the emotional roller coaster this stuff causes. So happy when it’s active then absolutely horrified with the aftermath. Happy to report that it has returned to “normal” and did so after about 3 weeks. I no longer use any anti roscacea creams. I get laser treatments 2 times a year and always have a layer of spf 110 on. I still get flare ups regularly but I manage with drinking lots of water and breathing exercises when I feel that tingling burn start. I hope this helps. I have noticed that the less I pay attention to it the better it is and the less other people notice. Take care and best of luck.

  7. Mandy says:

    bad reaction. When I used it for the first time, quickly calmed down my redness. But after 5-day use, the redness got worsened after being applied after 3pm every day (applied once at 8am)!!!! So disappointed and I thought I’m the only one who is so weird…. but I found that I’m NOT ALONE. I’m still having serious redness when typing this comment. Currently taking Klacid at the same time, hope it will help me to calm down the side effect more quickly….

  8. Kristi Mantere says:

    I also had a very bad reaction to mirvaso. I am so dissapointed as I was really hoping to find something to help my redness. My metro gel keeps the bumps away but as I approach 40 the redness Is getting worse. This cream burns my face and causes a painful flare up.

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