Mirvaso has been approved by the FDA.

[mwilson21]

I too have had a bad rebound effect from the Mirvaso. The first time I used it I was so pale my wife thought I was sick or something. On the 3rd day of use, I started noticing the cream wearing off at around the 5th hour so I had to reapply to just get me thru the day at work. I reported back to my doctor and she suggested putting it on after lunch. This helped a little better but the rebound effect would strike at night and was unbearable. After a couple weeks of Mirvaso application, my flushing triggers were off the charts again and as bad as they have ever been. It took about 4-5 weeks for my face to completely calm down.

I thought this was going to be the "one" but it actually made my rosacea much much worse. My doctor said she had only prescribed it to a few others but hadn't heard of the rebound flushing I complained about. She told me to discontinue use which is what I did. Very disappointing that the FDA approved this cream without the proper due diligence.

[Brady Barrows]

mwilson21 makes the 120th negative report collected so far. Only 36 positive ones as far as I know.

[Mister_Twiggy]

Thank You

Thank you for compiling the list Mr. Barrows. I've bought a bottle of Mirvaso, but I haven't touched it yet.

[mwilson21]

mwilson21 makes the 120th negative report collected so far. Only 36 positive ones as far as I know.

Are you planning on sending our responses to Gaulderma or the FDA? Thanks

[johnabetts]

Are you planning on sending our responses to Gaulderma or the FDA? Thanks

I doubt there is any need to do that. Even if Galderma or the FDA are not following this (and other) discussion(s) directly themselves, I am certain that there will be, or has been, reports made to them quoting these findings.

Also, the comments made by Galderma sales reps in December/January in their own forum (http://www.cafepharma.com/boards/) and their dissatisfaction with the company they represent and the products they are attempting to sell do not make amusing reading. This is in addition to the huge changes being made at the top of the company such as the replacement of senior and top executives and L'Oreal selling off all of their interest in Galderma to Nestlé (getting out while there's something left to get out of). The board at Galderma can't help but know of the problem.

[Susan Heller]

Re: I am having a bad side effect with Mirvaso

News today that Galderma has succeeded in gaining FDA Approval for Mirvaso – the brand name chosen for the product that during development was known as Sansrosa, CD07805/47 and Col-118.

The Brimonidine Tartrate 0.33% Topical Gel is expected to be available as soon as next month.

Great news that approval has been granted after so many years of waiting for rosacea sufferers following the development of this product.



Note the Safety Information

Last week I was given two tiny samples of Mirvaso to try before making the expensive investment in filling a prescription.

I barely used a small pea portion on both cheeks. Within 15 minutes I noticed a significant change with the redness. I was excited and thought I found "the cure". My left ear and side of neck started to throb. I had the worst earache I have ever experienced. This product is a vasoconstrictor and I think it had effected the blood flow to my ear. I quit using it for a couple of days and gave it another try. Same thing happened.

Has anyone had this experience? Obviously, I am not going to be able to use this product.

I am so disappointed.

Susan

[Brady Barrows]

Are you planning on sending our responses to Gaulderma or the FDA? Thanks

At this time there are no plans to do this.

[Brady Barrows]

It is important to note in the prescription handout of Mirvaso the following:

5.4 Erythema and Flushing
Some subjects in the clinical trials discontinued use of MIRVASO topical gel because of erythema or flushing. The effect of MIRVASO topical gel may begin to diminish hours after application. For some subjects in the clinical trials, erythema was reported to return worse compared to the severity at baseline [see Adverse Reactions (6)].


17 PATIENT COUNSELING INFORMATION

• Some patients using MIRVASO topical gel may experience erythema or flushing.
• Patients should report any adverse reactions to their physician.

[roasceaclearwannabe]

Have you seen this advert for mirvaso.... http://www.youtube.com/watch?v=M9JPn3gZkoE

[lparker]

I have a question. I stopped taking this Mirvaso on Saturday it is now Wednesday. Flushing has improved with my diet but not much. Now it is still early, I know it can take 4 or 5 weeks to see improvement and I took it for 2 months. But my question is does Mirvaso really get into the blood stream? I was trying to fast the other day which I do periodically and my face turned extremely red, I thought I might have to go to the emergency room. So... I wont be doing that again. But, is my body trying to get this stuff out of the bloodstream. I am confused.... Or is this physical state the new norm for me. Constant flushing from heat and foods.

[roasceaclearwannabe]

Found this article too about rebound flushing from Mirvaso: http://download.journals.elsevierhea...2213011778.pdf

[Andy33]

After reading nearly every post on here since Mirvaso was released . You would want to be crazy to put this stuff on your face day after day . pure madness .

[lparker]

I completely agree Andy33. I only wish that I had found this forum earlier. But I am glad I found it when I did. I have accepted the fact that I have permentantly damaged my skin, but I have hope that there is a solution to correct some of the damage. I honestly will never ever put a topical cream on my face of any kind from doctor unless I have researched the heck out of it.

[mwilson21]

Last week I was given two tiny samples of Mirvaso to try before making the expensive investment in filling a prescription.

I barely used a small pea portion on both cheeks. Within 15 minutes I noticed a significant change with the redness. I was excited and thought I found "the cure". My left ear and side of neck started to throb. I had the worst earache I have ever experienced. This product is a vasoconstrictor and I think it had effected the blood flow to my ear. I quit using it for a couple of days and gave it another try. Same thing happened.

Has anyone had this experience? Obviously, I am not going to be able to use this product.

I am so disappointed.

Susan

My ears sufferred the worst rebound effect by far. They were throbbing for weeks!

[lparker]

I have lupus and I felt really sick ever since I started taking this, like I was having a lupus flare. But, I didn't know that a topical formula could be the cause. Now since I stopped taking this stuff, I do not feel sick anymore. I know that it says on the package if you have sjogren's syndrome or sclerodoma that you should use this stuff with caution. Well, I think if you have lupus too.