Mirvaso has been approved by the FDA.

[alyfpet]

update

I figured I would follow through on my previous posts with an update. I won't go into how I have progressed over the past month, since I've already posted about that, but just say where I am now.

I am more than 4 weeks since I last used Mirvaso and my skin is still much more red and inflamed than before I used it. Before use, my persistent redness was around my nose/nostril area, which was where I applied the Mirvaso. My cheeks were not red unless I flushed. My skin was not hot unless I flushed. I had periodic tingling and itching around my nose in the red areas (which I hated, but now in retrospect wasn't so bad). I have ocular rosacea, which is annoying (and not very attractive) but manageable. This has been my stable condition for years.

After Mirvaso use, my nose and cheeks are constant red and warm. My face is swollen and puffy, and the skin feels tight. When I look closely at my face, I see little blood vessels in the under the red, which were not visible before. Where my face is puffy, the vessels are more apparent. When I flush now, my face stings, whereas before it just felt hot. The places around my nose that tingled and itched before, feel burny and stingy now instead. Needless to say, the past month has not been a very good one for me.

I finally saw my derm, who I have been seeing for years and knows my skin very well. He is a very good doctor. He examined me and noted my face is red where it was not before and that the skin was warm when he touched it. He examined my skin/blood vessels with that little magnifier thing. He then looked for dilated vessels in my hands to make sure I wasn't experiencing blood vessel dilation elsewhere, and noted none.

He said that this type of reaction was not noted in any of the clinical trials of Mirvaso. He said that redness noted in the trials was either a return to baseline or a rebound redness that resolved. He said since this has not resolved, it is not something that was reported in the trials and that I should report it to the FDA and that he would need to fill out paperwork, which he would do. He said that my reaction was concerning.

He then noted that he didn't think that 3 days of use would have resulted in more blood vessels growing, and that my current condition is more likely a result of the blood vessels still being reactive from the medicine (ie, from dilation of vessels as opposed to new ones). He is hopeful that we can calm the vessels back down by attacking it from many directions. He wanted to put me on a higher dosage of antibiotics (I'm currently on Oracea), but my previous experience with side effects makes that not a great option. So this is what I will be doing daily: Oracea, Clarinex, Aleve, and cold whole milk compresses 2 x day. And also to continue on an antidepressant, which I started 2 weeks ago because this whole experience has really taken a toll on me emotionally/psychologically. He thought that anything helping with my stress at this point would also have a good effect on calming down the blood vessels. He said that with these treatments, we can hopefully train the vessels to go back to where they were before they were stirred up by the Mirvaso.

I see him again in 6 weeks. He typically is booked 3 months in advance, so the fact that he's seeing me in 6 weeks lets me know he is taking this seriously. He said at that time, we may consider a beta blocker if I'm not improved.

I must admit, I broke down a bit during the appointment. I usually try not to be emotional during my appointments and to stay positive, because I don't want to come across as a hysterical person, but this time I ended up in tears. I am so scared that this is my new face.

So, there is my update. I am still struggling, but I do feel grateful that I have a good doctor who is my partner in this. I don't know what I'd do if I had a dismissive derm like some people post about.

A

[Starlite]

Oh it sounds like you really do have a caring Doctor who is on your side. I am glad for that at least. I'm sorry you are going through this. Please keep us up dated as things progress.

[Makron]

I found this study below interesting.

This study shows that 36 people out of 140 had allergic reactions to brimonidine. That is 25 % of the test subjects. Now when the trials where conducted by galderma people who where allergic to brimonidine where not eligable as test subjects. The adverse effects many of you are experiencing is perhaps simply allergic reaction to brimonidine. That would perhaps explain the higher rate of negative experiences then those by the test subjects in the trials. How many of you that have tried mirvaso have tested if you are allergic to brimonidine before you used mirvaso ?

Source: http://www.ncbi.nlm.nih.gov/pubmed/11865954


Exclusion Criteria:

More than 5 facial inflammatory lesions (papules or pustules) of rosacea,

Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator,

Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure),

Female who is pregnant or lactating.


Source: http://browse.feedreader.com/c/Rosac...roup/464605237

[Birdie]

I figured I would follow through on my previous posts with an update. I won't go into how I have progressed over the past month, since I've already posted about that, but just say where I am now.

I am more than 4 weeks since I last used Mirvaso and my skin is still much more red and inflamed than before I used it. Before use, my persistent redness was around my nose/nostril area, which was where I applied the Mirvaso. My cheeks were not red unless I flushed. My skin was not hot unless I flushed. I had periodic tingling and itching around my nose in the red areas (which I hated, but now in retrospect wasn't so bad). I have ocular rosacea, which is annoying (and not very attractive) but manageable. This has been my stable condition for years.

After Mirvaso use, my nose and cheeks are constant red and warm. My face is swollen and puffy, and the skin feels tight. When I look closely at my face, I see little blood vessels in the under the red, which were not visible before. Where my face is puffy, the vessels are more apparent. When I flush now, my face stings, whereas before it just felt hot. The places around my nose that tingled and itched before, feel burny and stingy now instead. Needless to say, the past month has not been a very good one for me.

I finally saw my derm, who I have been seeing for years and knows my skin very well. He is a very good doctor. He examined me and noted my face is red where it was not before and that the skin was warm when he touched it. He examined my skin/blood vessels with that little magnifier thing. He then looked for dilated vessels in my hands to make sure I wasn't experiencing blood vessel dilation elsewhere, and noted none.

He said that this type of reaction was not noted in any of the clinical trials of Mirvaso. He said that redness noted in the trials was either a return to baseline or a rebound redness that resolved. He said since this has not resolved, it is not something that was reported in the trials and that I should report it to the FDA and that he would need to fill out paperwork, which he would do. He said that my reaction was concerning.

He then noted that he didn't think that 3 days of use would have resulted in more blood vessels growing, and that my current condition is more likely a result of the blood vessels still being reactive from the medicine (ie, from dilation of vessels as opposed to new ones). He is hopeful that we can calm the vessels back down by attacking it from many directions. He wanted to put me on a higher dosage of antibiotics (I'm currently on Oracea), but my previous experience with side effects makes that not a great option. So this is what I will be doing daily: Oracea, Clarinex, Aleve, and cold whole milk compresses 2 x day. And also to continue on an antidepressant, which I started 2 weeks ago because this whole experience has really taken a toll on me emotionally/psychologically. He thought that anything helping with my stress at this point would also have a good effect on calming down the blood vessels. He said that with these treatments, we can hopefully train the vessels to go back to where they were before they were stirred up by the Mirvaso.

I see him again in 6 weeks. He typically is booked 3 months in advance, so the fact that he's seeing me in 6 weeks lets me know he is taking this seriously. He said at that time, we may consider a beta blocker if I'm not improved.

I must admit, I broke down a bit during the appointment. I usually try not to be emotional during my appointments and to stay positive, because I don't want to come across as a hysterical person, but this time I ended up in tears. I am so scared that this is my new face.

So, there is my update. I am still struggling, but I do feel grateful that I have a good doctor who is my partner in this. I don't know what I'd do if I had a dismissive derm like some people post about.

A

Alyfpet, hi. Your experience with mirvaso makes all of us with rosacea mad mad mad for you. I'm very glad you have a Dr who is competent and that you trust. I hope it gives you some hope to know that I have
Had some bad flares in years past and they did indeed eventually calm down. I've said this before in other
Posts, and I'm sure it sounds funky to some, but if you can find a quite place 10 minutes a day (twice)
Do some deep breathing exercises, you may find relief in burning, stinging, redness. If you don't know
How to do this, pm me and I will give you the steps to successful deep breathing. I really believe it
Will get better. Best regards, birdie

[Starlite]

Alyfpet, hi. Your experience with mirvaso makes all of us with rosacea mad mad mad for you. I'm very glad you have a Dr who is competent and that you trust. I hope it gives you some hope to know that I have
Had some bad flares in years past and they did indeed eventually calm down. I've said this before in other
Posts, and I'm sure it sounds funky to some, but if you can find a quite place 10 minutes a day (twice)
Do some deep breathing exercises, you may find relief in burning, stinging, redness. If you don't know
How to do this, pm me and I will give you the steps to successful deep breathing. I really believe it
Will get better. Best regards, birdie

Birdie.. the deep breathing instructions is a thread worth sharing with all of us .. if you don't mind starting one?

[dogkrazy]

update from me

I used Mirvaso off and on..I have found that it is more like a band aid..so if I have a day I want to look less red I use it and it really does blanche out the redness..it doesn't cure of course
I have also been using some zicam on my face..call it desperation..sometimes I think it helps

But on an odd note..I have been anemic for a long time but only recently treated with iron, but this week I decided to add the B vitamins..esp B 12 even tho my doctor didn't suggest it along with the iron. This morning I woke up and my face looks better than it has in months...curious if anyone else has had a similar exp. The iron didn't change anything but the B has or it is simply a coincidence. I will follow longer and try and let folks know if it does help

as an FYI..48 yr old female and my anemia manifest in many ways..including coughing and something stuck in my throat feeling...I have had this cough for years but it was unbearable about 8 months ago..the iron has totally cured it!!
I also get sores on the corners of my mouth called cheliosis..the B's should cure this..which leads me hopeful, just maybe it will help the rosacea as well..that would truly be a blessing

[alyfpet]

Birdie.. the deep breathing instructions is a thread worth sharing with all of us .. if you don't mind starting one?

Thanks Birdie and Starlite for your good wishes. Hopefully my next post will be some good news.

I agree that the deep breathing instructions would be helpful. I must admit, though, I'm finding it difficult to find the time to do the milk compresses twice a day, as I work very long hours and have a two year old, who I can't get to sleep before 11 pm. Not a lot of "me time," if you know what I mean. But I'm trying.

I also want to say that I filled out the FDA Adverse Event report, and I found it odd that they didn't ask for contact information of my doctor. You would think that a report confirmed by a doctor would be a bit more convincing, but at no point did they ask for that information. I am going to follow up with my derm to make sure that he submits a report too. He said that he would, but I just want to make sure that my report is taken seriously.

On my way to a Halloween parade with my daughter now. I wish I could wear some makeup, as I'm going as a witch with her, but I don't dare try. But I'm going to try to relax and enjoy the parade. I love Halloween!

[maskielli]

. The adverse effects many of you are experiencing is perhaps simply allergic reaction to brimonidine. That would perhaps explain the higher rate of negative experiences then those by the test subjects in the trials. How many of you that have tried mirvaso have tested if you are allergic to brimonidine before you used mirvaso ?

That is actually possible. In the rosaceasupport thread around 3 or 4 people have been touting that the Mirvaso works for them if they apply benadryl cream to there faces (anti-histamine). Apparently its not a one off fix and you need to use it regularly but one person states that before putting on the mirvaso and a few hours after he puts benadryl on his face. He claims that he barely needs the benadryl anymore after doing this for three weeks (and hes actually updated several time), so its possible that even the rebound from brimonidine people had years ago was simply an allergic reaction that basically everyone has (but still highly unlikely). Would be interesting if anyone who is still using Mirvaso or suffering from its rebound to try to use benadryl aswell or even any type of anti-histamine and see if it helps.

Also the main guy supporting the benadryl says his doctor recommended it to him

[nat007]

I personally doubt the rebound mentioned here is allergic. Maybe 1 or 2% potentially, but not the rest. Simply because everyone has a decent amount of time where they get pale, like 6-8 hours, before rebound sets in and with an allergy you would assume this starting a bit sooner for some at least. Antihistamines can help with flushing even when you have no allergies or detectable IgE levels, because they block histamine release and histamine plays a normal role in vasodilatation, for everyone, not just those allergic. Of course, when you are allergic you get an abnormal shot of histamine release.

So I think the rebound mentioned is a natural characteristic of the brimonidine, as also mentioned with regars to the occular counterpart Aphagan:

http://www.medicines.org.uk/EMC/medicine/109/SPC/Alphagan/

Here is says: " There is very limited information regarding accidental ingestion of brimonidine in adults. The only adverse event reported to date was hypotension. It was reported that the hypotensive episode was followed by rebound hypertension."

And those with very fragile blood vessels and reactive rosacea seem therefore just very prone to the rebound vadodilatation.

Please stop bashing people who are complaining about this by the way, getting pretty annoying how some here keep talking down on others sharing their experiences.

[Starlite]

I found this study below interesting.

This study shows that 36 people out of 140 had allergic reactions to brimonidine. That is 25 % of the test subjects. Now when the trials where conducted by galderma people who where allergic to brimonidine where not eligable as test subjects. The adverse effects many of you are experiencing is perhaps simply allergic reaction to brimonidine. That would perhaps explain the higher rate of negative experiences then those by the test subjects in the trials. How many of you that have tried mirvaso have tested if you are allergic to brimonidine before you used mirvaso ?

Source: http://www.ncbi.nlm.nih.gov/pubmed/11865954


Exclusion Criteria:

More than 5 facial inflammatory lesions (papules or pustules) of rosacea,

Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator,

Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure),

Female who is pregnant or lactating.


Source: http://browse.feedreader.com/c/Rosac...roup/464605237

Oh man.. I missed seeing this earlier! THANK YOU for posting that. This information gives us a hint at how they skewed the study results. When I googled "Mirvaso contraindications", I got this report by the FDA and it is not mentioned there, in fact is says "NONE". http://www.accessdata.fda.gov/drugsa.../204708lbl.pdf I then googled "Mirvaso allergic reactions" and found this.. mirvaso side effects

Note: This document contains side effect information about brimonidine topical. Some of the dosage forms listed on this page may not apply to the brand name Mirvaso.

General

The most common side effects included erythema, flushing, skin burning sensation, and contact dermatitis.

Dermatologic

Very common (10% or more): Erythema, flushing
Common (1% to 10%): Rosacea, skin burning sensation, contact dermatitis, dermatitis, warm skin, acne, skin pain

Hypersensitivity

Common (1% to 10%): Allergic contact dermatitis

Nervous system

Common (1% to 10%): Headache, paraesthesia

Ocular

Common (1% to 10%): Increased intraocular pressure, blurred vision

Respiratory

Common (1% to 10%): Nasopharyngitis, nasal congestion

Not exactly coming across as honest and straight forward information, is it?

Thanks Birdie and Starlite for your good wishes. Hopefully my next post will be some good news.

I agree that the deep breathing instructions would be helpful. I must admit, though, I'm finding it difficult to find the time to do the milk compresses twice a day, as I work very long hours and have a two year old, who I can't get to sleep before 11 pm. Not a lot of "me time," if you know what I mean. But I'm trying.

I also want to say that I filled out the FDA Adverse Event report, and I found it odd that they didn't ask for contact information of my doctor. You would think that a report confirmed by a doctor would be a bit more convincing, but at no point did they ask for that information. I am going to follow up with my derm to make sure that he submits a report too. He said that he would, but I just want to make sure that my report is taken seriously.

On my way to a Halloween parade with my daughter now. I wish I could wear some makeup, as I'm going as a witch with her, but I don't dare try. But I'm going to try to relax and enjoy the parade. I love Halloween!

Thanks for letting us know you filed with the FDA. Would you mind telling us exactly how that went? You called a specific number and then...?

Enjoy your Halloween festivities!!

[nat007]

http://www.accessdata.fda.gov/drugsa.../204708lbl.pdf I then googled "Mirvaso allergic reactions" and found this.. mirvaso side effects

FULL PRESCRIBING INFORMATION
...
"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)].
But then its stated that only 4% of the test panel had redness as an adverse reaction and only 3% had flushing.. I can't believe those percentages are so low... It makes no sense given the consistant rebound complaints here. Criteria for the test persons was "persistent(nontransient) erythema associated with rosacea" (does that require a diagnosis or can it also be non-rosacea redness?). My guess is that a good chunk of the test people (seemed a smale sale test too with 1210 subjects) did not suffer from facial flushing to begin with. Hence the lack of rebound flushing issues. The former president of Galderma seemed to imply in is interview, posted earlier here, that he aimed this product more specifically at those with redness and flushing (compared to another upcoming product for the p&p sufferers). Why didn't they do a specific test on rosacea patients with flushing issues? Since they aimed this product on this subgroup as well it seems.

Anyway, I'm sure there are explanations for all of this and lets hope Mirvaso works well for future tryers here :/

[MB1024]

Wanted to post my experience so far here to warn others. Definitely had rebound flushing. I've been using mirvaso daily for the past three days, and today is my fourth day. Didn't apply it yet, and as it's been about 24 hours now, my cheeks and nose area have gone bright red. Much, much worse than the original redness. I'm a blusher and over the past several months noticed a slight persistent redness over my cheeks. Went to the derm and he could not confirm rosacea, but agreed that I was at risk due to my frequent blushing problems. I wish I could've used this product longer, but I'm nervous that the rebound flushing will be much worse the longer I use it. Face is slightly warm and at least twice as red as it was when I started. I did notice the ghostly, pale look the first two days of use as well. Seems my reaction has been fairly common.

I don't want to say that the product isn't going to work for anybody, but for what it's worth - it was a disappointment for me. Hoping this doesn't last too long. Looks like my cheeks all the way up my jawline are inflamed.

[Birdie]

Wanted to post my experience so far here to warn others. Definitely had rebound flushing. I've been using mirvaso daily for the past three days, and today is my fourth day. Didn't apply it yet, and as it's been about 24 hours now, my cheeks and nose area have gone bright red. Much, much worse than the original redness. I'm a blusher and over the past several months noticed a slight persistent redness over my cheeks. Went to the derm and he could not confirm rosacea, but agreed that I was at risk due to my frequent blushing problems. I wish I could've used this product longer, but I'm nervous that the rebound flushing will be much worse the longer I use it. Face is slightly warm and at least twice as red as it was when I started. I did notice the ghostly, pale look the first two days of use as well. Seems my reaction has been fairly common.

I don't want to say that the product isn't going to work for anybody, but for what it's worth - it was a disappointment for me. Hoping this doesn't last too long. Looks like my cheeks all the way up my jawline are inflamed.

Hi MB1024, sorry for these troubles. This is a disaster drug for many on the forum. Could you please
Keep us posted as to how you are doing in your recovery? I'm going to start a new thread directly
For this issue. Best regards, birdie.

[pghrosacea]

Pretty bad experience from me too...

I have used mirvaso ONE TIME. 3 days later i am still experiencing terrible rebound flushing. I'm a real person. Moderate Rosacea (no bumps just redness and scaly skin) sufferer for ten years. Here's a log i've been keeping if you're interested:

10/24 - 2pm - Visit with new dermatologist. Derm prescribed Permethrin and I asked for Mirvaso. Derm believes i may have high demodex amounts because of rough skin on forehead. He believes this may also contribute to facial redness. I am to use permethrin twice daily for a month and mirvaso once daily and then follow up.
5pm- wash face with cerave. dried face. Applied Mirvaso. Took special care to apply evenly.
5:30pm - Face looks terrible. I looked like a leopard some areas are way whiter than usual some areas are way redder than usual.
6:30pm - Face actually looks incredible. It was nice to see how i could look after dealing with facial redness for so long. To be honest i was amazed at the results.
10:30pm - Bedtime. Face is even whiter than at 6:30. At this point i'm so hopeful that i've been cured.
10/25/13 3:30am - Woke up because i was paranoid about going to work using mirvaso. Face looks good. Whew!
4:30am - Cerave shower. Went back to bed.
6:30am - Wake up again. Cheeks are more flushed than i've ever seen in my entire life.
8am - Redness down to half dollar size on left cheek. I sat out on porch in cold (40 degrees) to help calm down redness and then drove 15 minutes ina cold car to work. Redness reduced from being in cold for a bit.
12pm - Don't feel very flushed. Right side is redder than baseline and so is forehead.
4pm - Was outside in cold (40 degrees) for half hour. Face looks good. Slightly red on right side.
5pm - took nap. woke up Left side of face is EXTREMELY flushed.
6pm - took shower with cerave. Applied to permethrin to entire face. Not using mirvaso ever again.
7pm - face looks not flushed. Better than baseline.
7:30pm - terrible flush. Worse than before. Worst of entire life.
10/26/13 10am - Flushed on both cheeks. slightly less flushed but still more than baseline.

I applied permethrin again to entire face was flushed for the rest of the day. took shower with cerave at 6pm and continued to have really bad flushing. Didn;t apply permethrin again didn't apply mirvaso again.

Woke up this morning (10/27/13) and face is still more flushed than baseline.

So i understand that i'm using to creams here but i believe mirvaso is the cause of my recurrent flushing. I'm going to stop using both and check back in with results.

My thoughts are that when mirvaso kicks in ( about 90 - 120 minutes after application, it's phenomenal. After about 12 hours i as more flushed than ever. The prescription says to only use once a day. It;s just not practical. i would have to wake up 2 hours before work and then not leave my place after the 12 hour span...

I hope this rebound flushing stops soon. maybe as this product gets developed more they'll think of better dosing or something?

[alyfpet]

fda report and update

Thanks for letting us know you filed with the FDA. Would you mind telling us exactly how that went? You called a specific number and then...?

I filed with the FDA on their MedWatch website at: https://www.accessdata.fda.gov/scripts/medwatch/

I received an e-mail confirming their receipt of my report: "Thank you for submitting your report to MedWatch, The FDA Safety Information and Adverse Event Reporting Program. This acknowledgement confirms that your report was received. Reports are added to a post marketing safety database with similar reports and reviewed by the FDA's post marketing safety staff. Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day. You will only be contacted for follow-up by FDA if additional information on this report is needed in our evaluation process."

I am curious to know whether anyone else has reported their experiences to the FDA. I think it will take several reports before they look into the drug a bit more carefully. I must say that I am starting to feel less depressed about this and a bit more angry. I was actually not totally surprised that I suffered a rebound. Being pretty knowledgeable about my condition, I asked my doctor about it before taking the drug. He said that there were reports of rebound, but they were rare and mild. So, I figured, OK, chances are I won't have a rebound because it is rare (this now appears to be untrue), and if I do, it will be mild and resolve (also appears that many people have had rebound that is more than mild; and certainly mine has not resolved). While the product information that came with the drug said that flushing and redness were side effects, it also said that it resolved with discontinuation (not the case for me, at least so far).

Had the product information said there is a 50% chance of rebound, even, I would not have tried it. And had it said, rebound may last for several days (let alone weeks), I would not have taken the chance. And I just can't imagine that nobody in the trial had the experience that so many are reporting on the forum. How can that be? Perhaps it does pose more of a risk to flushers. But shouldn't that population have been studied in the trials? I mean, that is their job: to make sure that the drug is safe for the population to which they are marketing it---rosaceans. And since flushers make up a big proportion of rosaceans, shouldn't they have studied that population before marketing a drug to them. They are supposed to be the experts, keeping us safe.

On a positive note, I think my face is a bit calmer today. I'm not sure if it is the antihistamine, Aleve, or the mild compresses, but it seems less red and does not feel as hot. The swelling, however, is still there and seems more noticeable today. The worst of the swelling is just above the creases from my nose to my mouth, which are very puffy. I didn't have this before, and it is weird to look at my face and see a different version of it in the mirror. It is much puffier. I am avoiding mirrors at all costs, even turning the lights down before I go into the bathroom, to stop reminding myself that this is happening. It would be easier to not focus on it if my skin didn't feel so taught on my face. But one step at a time. I am happy that it does not feel as hot as it did just a few days ago.