Report adverse reactions to Mirvaso to the FDA and Galderma

fda-adverse-reaction

The reaction online by new users of Mirvaso, you would have to say, has not been good. The reports of rebound flushing, that is; worse flushing after using Mirvaso compared to before, far outweigh happy users.

From those users who have posted online at the various Mirvaso threads, the trend for adverse reactions appears to be much higher than experienced by the large Phase 3 Mirvaso clinical trials. Rebound flushing from Mirvaso has even attracted a newspaper article on the topic.

For example, going by the clinical trial results quoted in the Mirvaso Prescribing Information one could expect to have adversely increased flushing in about 10% of users and increased redness in about 8% of users. As mentioned, online reports appear to be much higher than this.

Officially Mirvaso is for the treatment of the non-transient i.e. permanent red face of rosacea, but published results from adverse reactions show that it can increase flushing, redness, burning, dermatitis, acne in some users. For more details see Will I have a Bad Reaction to Mirvaso?

What Should I do?

If you are experiencing worsening of your facial redness, and you feel that it is because of a reaction to Mirvaso, you can report it as an adverse event to Galderma and to the FDA.

The Mirvaso Prescribing Information has a short note about what to do if you have a bad reaction after using it.

To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

It appears that you can click through to a voluntary reporting form here;

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1

where you can add details of your bad experience with Mirvaso.

Users who have contacted Galderma have reported success in obtaining a refund for their purchase.

Please let us know

If you do officially file an adverse event report, please let us know if you hear anything back from the FDA or Galderma.

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About the Author

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

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18 Reader Comments

  1. Tracey says:

    I will have to agree….the first few days redness was gone for at least 8 hours, but after a few days of use, I had immediate redness after just six hours, even more so than before using Mirvaso. I would almost classify this as a drug that has addictive qualities, you use it a few times and its great, but the more you use, the more you HAVE to use.

    • Lauren says:

      I couldn’t have said it any better myself. I stopped using it after my redness was unbelievably bad – to the point where my face was throbbing and swelling, and I could feel a slight lump over the area to where I applied the Mirvaso. Mirvaso really does work well, but for me, once my face started to flare up, it was all over. I have never had so many people ask IF MY FACE WAS OKAY. I am so completely disappointed by not only how unsuccessful this product was for me, but how much WORSE my face is now before I used it. I stopped using it and now my face reacts so badly to flare ups, it makes me want to use the gel all over again. I truly encourage you to try this product out on a small area of your face first. Believe me, you don’t want any parts of these horrific side effects.

  2. Marilyn says:

    It almost seems like it doesn’t help the redness out for too long, if you have to keep the routine of putting it on & so many seem to have adverse reactions.. I kinda of wonder how the tests subjects, or if there were any, during the trial phase of this drug, showed an improvement with their rosacea …And, wondering, too, what is the long-term affects of this prescription might be?,

  3. Jimmy says:

    Where is your request to report positive results? Your request betrays your intensions.

    David, your campaign to report adverse effects will not work because it would require persons to identify themselves. Face it. Mirvaso works well and is succeeding for many patients.
    -Jimmy

    • David Pascoe says:

      Hi Jimmy, all those who have positive reports are more than welcome to put them on quite a few different pages across the rosacea web sites – for eg Mirvaso User Reviews.

      The problem is that good, positive reviews take a while to assemble i.e. people need a few weeks to be sure. Even though it has been available for 3 months, positive reviews are still hard to find reported.

  4. Tracey says:

    Jimmy,
    I have nothing positive to say about this drug….it cost me $50 and three weeks of misery! The first few days were great, but after that it was a horrible…my face was redder than before starting mirvaso, it was like a drug, the more you used it, the more you had to use it, until you go cold turkey for days before going back to pre mirvaso.
    Ill pit my fu name on it if needed, I want my money back!!

  5. rebecca says:

    This was the worst drug I could have ever put on my face. I never got flushing before and now I do. I can’t take even a sip of alcohol without my face burning. My left cheek gets to rashy looking as the day goes on. I’m so sad and depressed over this.

    • Tara says:

      Hi, I am dealing with the same after effects of mirvaso. I am cold turkey for 3 days now and still having effects. How long until you went back to normal with the redness?
      Thanks
      Tara

  6. Glenn Davidson says:

    I will be trying Mirvaso on prescription whenever the topical cream gets licensed in Europe/UK.
    I currently use the actual brimonidine eye lotion on my face to good effect,so have confidence in this new product that will benefit my overall health.
    Will leave an update when Im up & running with Mirvaso.

  7. Parker says:

    I hate this product! I cant eat or drink anything excluding water and some vegetables without getting splotches all over my face. It is horrible. I never had a problem to this extent before. Just a little minor redness. This made the redness ten thousand times worse. This product should be banned!

  8. Jeff Baird says:

    Awful, awful product. I have a permanent red face so I tried this mirvaso crap. Literally one of the worst mistakes I have ever made. First day was great, I was as pale as I had been in years. Next morning I awoke to horror, solid redness worse than any ive ever had that felt like fire. It still has not subsided and I am worried it will not return to my pre-mirvaso state. DO NOT USE this terrible product.

  9. Willie says:

    This product didn’t work for me at all. I only used it for two days (very small amount both times) and at first it seemed to work. The effect wore off after 8-9 hours and the rebound redness kicked in. Today I didn’t use the product at all. The result is that today my face has been redder than ever before. After googling Mirvaso I found these reviews and I will never be using it again. I strongly suggest anyone keep away from this product. Very disappointed :(.

  10. Rach21 says:

    Does anyone have any advice to try and speed up the recovery period? My fiancé and I are getting married in 10 days. He started using mirvaso in the hope his redness would be gone but he’s suffering with flushing worse than ever before. Any tips GREATLY appreciated!

    • Rebecca says:

      I think the horrible redness and flushing will be gone by then. It took me a few months to feel normal. But the worst part will be done in a week or so. He could try Benadryl and ice packs. The meds just have to get out of his system. I’m so sorry he used it. Horrible mistake I made too.

  11. Lauren says:

    STAY AWAY FROM MIRVASO!!!!!!!!!!!!!!!!!!!!!!!!!! HORRIBLE!!!!!!!!!!!!!!!!!!!!!

  12. Alba says:

    Mirvaso suuuuuuuuuuucks!!!!

  13. Cathie Walter says:

    I too have had terrible flushing. This is days after stopped using the product. My face feels like it is on fire. My eyes turn red too. It’s worst in sunlight. I took pictures. I am contacting my dermatologist to see if I should get laser treatment to stop the redness.

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