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  • Originally posted by Brady Barrows View Post
    33% would be close to the percentage in the results of the Blondeau/Rousseau paper that showed 25% had an allergic reaction. Flushing could be a side effect to an allergic reaction to brimonidine or you could call it a flushing trigger.

    In item #6 of the drug handout on Mirvaso, it states, "Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice." So I think this covers them. Galderma is simply saying that what happens in a clinical trial may not be what happens in actual treatment of this drug. Galderma also clearly warns those who may use this treatment the following:

    "A total of 276 subjects applied MIRVASO topical gel for at least one year. The most common adverse events (•> _ 4% of subjects) for the entire study were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%)." So here is number is 10% of the subjects who experienced the adverse event of flushing. But notice that the others percentages of some who had adverse events of erythema, rosacea (what is the difference between erythema and rosacea anyway), nasophyaryngitis, skin burning sensation, increased intraocular pressure and headache. Now how do you interpret the percentages of those who received these adverse events? Do you add all the percentages together? The main point being is that the product insert that comes with Mirvaso explains clearly that some subjects experienced adverse events. What makes anyone feel that these adverse events would not happen to them based upon these findings? It is very clear if one reads the product insert that comes with Mirvaso that one could have any of these adverse events. Galderma has covered themselves by giving warnings over and over in the product insert. What about these warnings here:

    Patients using MIRVASO topical gel should receive the following information and instructions:
    • This medication is to be used as directed by the physician.
    • It is for external use only.
    • MIRVASO topical gel should not be applied to irritated skin or open wounds.
    • Avoid contact with the eyes and lips.
    • Patients should wash their hands immediately after applying the medication.
    • Some patients using MIRVASO topical gel may experience erythema or flushing.
    • Patients should report any adverse reactions to their physician.
    • Keep out of reach of children.


    I particularly like the third bullet point, 'should not be applied to irritated skin.' So if you have irritated skin you should not not use Mirvaso. What part of this warning do you not understand? So if you decide to use Mirvaso for your rosacea and it gets worse or you experience flushing (see the bullet point #6) whose fault is this? Galderma? I don't think so. You have decided to accept the risks of the treatment. This is called the benefit/risk ratio which is what doctors learn in medical school. A patient ultimately must decide what the benefits and the risks of taking any treatment after being clearly explained these benefits and risks are. Ultimately the patient is responsible.

    If you didn't read the drug insert is this Galderma's fault? You opened the package and the insert comes with it. If you would like to read the insert yourself click here.

    Good post Brady. Without going into details, the main thing that strucks me personally is still that reading this information gives the average reader the impression that less than 10% of test persons experienced flushing, erythema, rosacea, redness, burning and so on. Whether or not they meant to add all these individually named side effect percentages up (making it a whopping 40%) is not clear. But usually they mean 10-4-8 etc % of the total 100%, so independently. From a topical, which is hyped as The big upcoming breakthrough for vascular rosacea, you might expect that they actually aimed it at people with irritated skin. I think the third bullet point was not so much referring to the sensitive, frail skin that many rosacea patients have, but more to open wounds, sores and visible structural damage of the epidermis?
    Sure, big pharmaceutical companies always cover themselves in all ways possible. Just reading the side effect and warning leaflet for simple paracetamol already scares the hell out of you. Do people get all thse side effects? No. Do they risk taking paracetamol? Most do, without devastating effects. But at the end of the day, this product seemed to be marketed and promoted as a relief for those with redness, burning and flushing, and to warn this same patient group for using it, kind of defies the purpose right? The fact they covered themselves in the side effect info, doesn´t mean people can´t be upset about this bad rebound flushing issue. They simply haven´t worked on that one and I am suspecting rebound flushing to be a intrinsic part of the brimonidine, and not an allergy related symptom(although allergies do occur of course and might set in motion the same response, but surely not after 8 hours of paleness, but a lot sooner? All the bad reviewers mentioned this same cycle, of initial great pale hours, then later, 6 to 8 hours often, followed by a tsunami of flaring). Just see how people using brimonidine in an eye gel, or for other purposes reported the rebound issue. It´s the essence it seems of such a chemical vasoconstrictor: it works and then it sets a natural rebound widening in motion for some time. I doubt Galderma has tried to even counteract any of that and that´s very disappointing, if you think about the actual effects that has on people with highly reactive vascular rosacea.
    My rosacea related blog: http://scarletnat.blogspot.com/2012/...edication.html

    Comment


    • Originally posted by nat007 View Post
      Good post Brady. Without going into details, the main thing that strucks me personally is still that reading this information gives the average reader the impression that less than 10% of test persons experienced flushing, erythema, rosacea, redness, burning and so on. Whether or not they meant to add all these individually named side effect percentages up (making it a whopping 40%) is not clear. But usually they mean 10-4-8 etc % of the total 100%, so independently. From a topical, which is hyped as The big upcoming breakthrough for vascular rosacea, you might expect that they actually aimed it at people with irritated skin. I think the third bullet point was not so much referring to the sensitive, frail skin that many rosacea patients have, but more to open wounds, sores and visible structural damage of the epidermis?
      Sure, big pharmaceutical companies always cover themselves in all ways possible. Just reading the side effect and warning leaflet for simple paracetamol already scares the hell out of you. Do people get all thse side effects? No. Do they risk taking paracetamol? Most do, without devastating effects. But at the end of the day, this product seemed to be marketed and promoted as a relief for those with redness, burning and flushing, and to warn this same patient group for using it, kind of defies the purpose right? The fact they covered themselves in the side effect info, doesn´t mean people can´t be upset about this bad rebound flushing issue. They simply haven´t worked on that one and I am suspecting rebound flushing to be a intrinsic part of the brimonidine, and not an allergy related symptom(although allergies do occur of course and might set in motion the same response, but surely not after 8 hours of paleness, but a lot sooner? All the bad reviewers mentioned this same cycle, of initial great pale hours, then later, 6 to 8 hours often, followed by a tsunami of flaring). Just see how people using brimonidine in an eye gel, or for other purposes reported the rebound issue. It´s the essence it seems of such a chemical vasoconstrictor: it works and then it sets a natural rebound widening in motion for some time. I doubt Galderma has tried to even counteract any of that and that´s very disappointing, if you think about the actual effects that has on people with highly reactive vascular rosacea.
      Thanks again Brady for organizing data and bringing more level headed thinking to the use of this
      Product. I have not used any quotes here re: the stats you have compiled but they are significant.
      Also, thanks to Nat above and all who also challenge the statistics and "legalese" which is clearly
      Finessed by Galderma and really ALL products/ companies that come with user pamphlets/warnings/risks and
      Directions ( you know, " Do NOT plug this toaster in next to your running bath water.")
      And for me, that's the bottom line truth: products in any category of life, not just pharmaceutical, protect themselves with the legalese semantics and then allow " lemons" ( automobiles-- notorious recalls
      And lawsuits) toys/ childcare products ( notorious deaths).... Pharmaceuticals.... Deaths, bodily damage,
      Are these products too easily released into the marketplace? I believe yes. And the reasons are varied
      But that's not for this thread. I agree with Nat above: See the last 4 lines of her response. Last,
      The only thing we can do is wait. Time will tell if this sucks like a lemon or flies like an eagle.

      Comment


      • It was suggested to me by one of the RRDi MAC Members to check the Cochran Organization for information on a drug:



        I did a search and Mirvaso showed no results.

        Comment


        • I have read a few posts now of users applying Benadryl lotion 5-6 hours after Mirvaso. This apparently assists with rebound. I am unsure if these posts are by trolls or actual users. Has anyone else tried this?

          Comment


          • Also I have been reading through some of the stuff on Cafepharma message boards regarding Mirvaso and some people are suggesting that the rebound can be avoided if you dilute the Mirvaso by mixing it with moisturisers etc.

            Comment


            • Originally posted by roasceaclearwannabe View Post
              Also I have been reading through some of the stuff on Cafepharma message boards regarding Mirvaso and some people are suggesting that the rebound can be avoided if you dilute the Mirvaso by mixing it with moisturisers etc.
              I don't know about Mirvaso but I mixed brimonidine with moisturisers and other relevant creams.
              It didn't stop rebound. Since brimonidine is the main ingredient in Mirvaso, it's very likely rebound flushing is inevitable unless they
              included something that neutralizes this side effect.
              I can't wait to get my hands on Mirvaso. Good thing is that it only requires one application to know
              whether it's going to suit you.
              But remember that not all people have bad reaction to brimonidine alone.

              Comment


              • "33% would be close to the percentage in the results of the Blondeau/Rousseau paper that showed 25% had an allergic reaction. Flushing could be a side effect to an allergic reaction to brimonidine or you could call it a flushing trigger."

                - Brady barrows


                This is not true. None of the tests subjects in the Mirvaso trials dropped out due to allergy because those who had allergys to any compound found in Mirvaso where not elegable for the tests.


                Exclusion Criteria:

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

                Comment


                • Originally posted by Makron View Post
                  "33% would be close to the percentage in the results of the Blondeau/Rousseau paper that showed 25% had an allergic reaction. Flushing could be a side effect to an allergic reaction to brimonidine or you could call it a flushing trigger."

                  - Brady barrows


                  This is not true. None of the tests subjects in the Mirvaso trials dropped out due to allergy because those who had allergys to any compound found in Mirvaso where not elegable for the tests.


                  Exclusion Criteria:

                  Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure),
                  Thanks for the clarification. Nevertheless, how does one know whether one is allergic to brimonidine unless one tries it? When a physician hands out a sample of Mirvaso to a patient, or hands the patient a prescription, which is what the results of everyone one of the anecdotal reports we have collected so far, allergies are not being ruled out, are they? Only in the study you are referring to above does any mention of ruling out allergies or sensitivities to brimonidine come into consideration. The anecdotal reports we are reading about could still be an allergy or sensitivity to brimonidine. How can one know the difference between an allergic reaction to brimonidine and a flushing or rosacea trigger caused by brimonidine? I supposed a trained dermatologist could make such a call but I think it would be a difficult one.

                  Comment


                  • I wholeheartdely agree with you on that. I made the same claim a month ago on this forum. I just wanted to Point out that the claim of allergy is not applicable to the trials but I do believe that the large number of people reporting problems is due to allergic reactions.


                    Below is my old post its on page 76 number 753 on this thread. I got alot of criticsim for it but it makes me happy now that you claim the same thing. Some people on this forum will do anything to discredit Mirvaso even without any personal interaction with it.


                    __________________________________________________ __________________________________________________ __________

                    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
                    Last edited by Makron; 18 November 2013, 05:47 AM.

                    Comment


                    • Some people on this forum will do anything to discredit Mirvaso even without any personal interaction with it.
                      That is a ridiculous statement.

                      As for allergy testing.
                      I had SEVERE rebound to brimonidine as I have reported in several posts.
                      It just so happened that during the rebound, I was waiting to start a new combined antibiotic regime and as a precaution, my physician sent me to an immunologist for a full immune assay, just to make sure there was nothing lurking in the background.
                      My flushing was regarded as impressive to say the least and attracted the attention of the 'suite' of specialists in the same department. They offered their own input regarding additional tests.

                      No allergy detected.

                      I don't believe the rebound in anyone has anything to do with allergy.

                      Also during the time of my rebound, as many old timers here may recall, I had daily discussions with Prof Art Ayers, who is a retired Harvard professor of biochemistry and genetics. I begged him to help me get through the rebound without more vascular damage. He felt there was nothing to be done and using brimonidine as I had done, in topical fashion for vascular constriction was one of the dumbest experiments I had ever undertaken. He said the drug was acting exactly as expected and I had to ride it out.

                      In addition, as for studies, ..... you can't always rely on them.

                      As many people know, brimonidine is used for treatment of glaucoma. My mother has this and treats with brimonidine. Her eyelids are always red, which makes her look as if she has been crying. Her optometrist said this is a common side effect.

                      I have retained the vascular damage from the brimonidine hell. No matter how much the rest of my face improves, my upper right cheek in particular, remains a vascular mess. The flushing was SO extreme, it was unbelievable.

                      I think by now, the evidence for rebound is blatantly obvious and anyone who continues to hold hope for this drug, wishing they might fall into the tiny minority that won't suffer rebound, or go from static redness, into a flushing syndrome, is .... dare I say it...being foolish.
                      As for allergy, even if allergy played a role in some people, no one can convince me that all those people just happen to be members of this forum.
                      Previous Numerous IPL.
                      Supplements: High dose Niacinamide, Vit K2, low dose Vit A. Moderate Dose Vit C, Iodine, Taurine, Magnesium. Mod- dose B's. Low dose zinc. Testing Quercetin.

                      Skin Care: No Cleanser, ZZ cream mixed with Niacinamide gel 4% and LMW HA 2%, ethyl ascorbate 2%.

                      Treating for gut dysbiosis.(This is helping).
                      Previous GAPS diet. Have now introduced lots of fibre.
                      Fermented Foods. Intermittent fasting -16-18 hours.
                      Oral Colostrum. Helps reduce food reactions.

                      Comment


                      • By last count, we have 1 positive report, 1 neutral, and about 20 negative reports. If you believe Galderma, we should have about 18 positive reports and 2 negative reports.

                        I realize there may be differences when it comes to reporting positive and negative reviews, but this is very far apart (basically the exact opposite of what we would expect).

                        If there was ANY other product/treatment out there with these results (that did not have reports backed by a drug company), we would all be saying to stay away from it. So if the users on this forum are so "atypical" that their results do not matter, what is the point of the forum? I believe the forum more closely represents a typical distribution of people and therefore our results coincide with that.

                        A lot of people on this forum do improve their symptoms. A lot of people share what has helped them and report the positive reviews just as we report the negative ones.

                        Comment


                        • Originally posted by Mistica View Post
                          That is a ridiculous statement.

                          As for allergy testing.
                          I had SEVERE rebound to brimonidine as I have reported in several posts.
                          It just so happened that during the rebound, I was waiting to start a new combined antibiotic regime and as a precaution, my physician sent me to an immunologist for a full immune assay, just to make sure there was nothing lurking in the background.
                          My flushing was regarded as impressive to say the least and attracted the attention of the 'suite' of specialists in the same department. They offered their own input regarding additional tests.

                          No allergy detected.

                          I don't believe the rebound in anyone has anything to do with allergy.

                          Also during the time of my rebound, as many old timers here may recall, I had daily discussions with Prof Art Ayers, who is a retired Harvard professor of biochemistry and genetics. I begged him to help me get through the rebound without more vascular damage. He felt there was nothing to be done and using brimonidine as I had done, in topical fashion for vascular constriction was one of the dumbest experiments I had ever undertaken. He said the drug was acting exactly as expected and I had to ride it out.

                          In addition, as for studies, ..... you can't always rely on them.

                          As many people know, brimonidine is used for treatment of glaucoma. My mother has this and treats with brimonidine. Her eyelids are always red, which makes her look as if she has been crying. Her optometrist said this is a common side effect.

                          I have retained the vascular damage from the brimonidine hell. No matter how much the rest of my face improves, my upper right cheek in particular, remains a vascular mess. The flushing was SO extreme, it was unbelievable.

                          I think by now, the evidence for rebound is blatantly obvious and anyone who continues to hold hope for this drug, wishing they might fall into the tiny minority that won't suffer rebound, or go from static redness, into a flushing syndrome, is .... dare I say it...being foolish.
                          As for allergy, even if allergy played a role in some people, no one can convince me that all those people just happen to be members of this forum.
                          Mistica,

                          Correct me if I am wrong. 'Rebound' is a fancy way of saying one is experiencing a rosacea flareup or flushing episode that is caused by a trigger, in this case, brimonidine. My dictionary:

                          rebound (verb) [ no obj. ] (rebound on/upon) (of an event or situation) have an unexpected adverse consequence for (someone, esp. the person responsible for it): Nicholas's tricks are rebounding on him.
                          rebound (noun) [ usu. as modifier ] the recurrence of a medical condition, esp. after withdrawal of medication: rebound hypertension.

                          (obviously there are more definitions for rebound but I picked the pertinent ones)

                          Found this medical dictionary that said:

                          rebound : a spontaneous reaction; especially: a return to a previous state or condition following removal of a stimulus or cessation of treatment <withdrawal of antihypertensive medication may lead to a rebound hypertensive crisis—Emergency Medicine>

                          So one of my questions is how does one differentiate an allergic reaction from rebound? Why can't what everyone is calling a rebound be an allergic reaction to a medicine? It seems logical to me it that what everyone is calling a rebound could be an allergic reaction to brimonidine since the reaction happens rather quickly. Most of the reports indicate this happens after the first or within the first few days. All the examples of rebound I found involve using the drug for a long period and then stopping the drug and a rebound happens, for example, rebound headaches.

                          Take for example those who have an allergy to penicillin. If given penicillin they react quickly with rashes, hives, itchy eyes, swollen tongue, and in severe cases anaphylactic reaction. Usually one finds out rather quickly if one has an allergy to penicillin. It seems logical to me that since most of the 20 or so reports that I have collected from the various anecdotal reports show that what everyone is calling 'rebound' may be an allergic reaction. I am no doctor, but when using medical terms we should try to use the correct ones.

                          I appreciate your comments on this.
                          Last edited by Brady Barrows; 18 November 2013, 05:44 PM.

                          Comment


                          • Originally posted by hozer2k View Post
                            By last count, we have 1 positive report, 1 neutral, and about 20 negative reports. If you believe Galderma, we should have about 18 positive reports and 2 negative reports.

                            I realize there may be differences when it comes to reporting positive and negative reviews, but this is very far apart (basically the exact opposite of what we would expect).

                            If there was ANY other product/treatment out there with these results (that did not have reports backed by a drug company), we would all be saying to stay away from it. So if the users on this forum are so "atypical" that their results do not matter, what is the point of the forum? I believe the forum more closely represents a typical distribution of people and therefore our results coincide with that.

                            A lot of people on this forum do improve their symptoms. A lot of people share what has helped them and report the positive reviews just as we report the negative ones.
                            Let's take Accutane, Doxcycycline and Oracea. If you did the same research on the positive and negative reports of using these three drugs you would probably find similar results. I have collected anecdotal reports in much the same manner as I have done for brimonidine. Read the list for Accutane. Read the list for Doxycycline. Read the list for Oracea. There are always negative reports for any prescription drug for rosacea. No exceptions. While brimonidine hasn't had many positive reports in this forum (and others) this may be because those who have positive reports simply don't join these groups. They don't care that others have had negative reactions to this drug, because it works for them. In a year or so, after long term use, we may be hearing from them and the damage that long term use with brimonidine produces. The longest this drug has been studied is on a few hundred who took it for a year. So, if a few hundred can take this drug for a year, without any 'rebound' or 'allergic reaction' I doubt if this drug will be taken out of market. Galderma may simply re-write the warning message in the insert so that those who decide to accept the risks of using brimonidine are warned clearly. I suspect in a year or so from now we will be hearing a number of these reports which to me is of more concern than these initial reports of those who quickly report it doesn't work for them. This is the story for every treatment for rosacea. It works for some but not for others.
                            Last edited by Brady Barrows; 18 November 2013, 05:59 PM.

                            Comment


                            • I would like to add my information to the list of users who have experienced worsened flushing in reaction to Mirvaso:

                              11/14/03 - Went to dermatologist for rosacea after not being on treatment for over a year; the redness showed up as triangles on each cheek and some minor bumps; received sample of Mirvaso and prescription to have filled; dermatologist told me to use each morning and to apply all over face, not just the triangles on each cheek, so my coloring would be even

                              11/14, 11/15, and 11/16/03 - Used the Mirvaso sample all over my face each morning (avoiding eyes and lips)

                              11/16/03 - After about 10 hours from last application (around 8pm) of Mirvaso, the right side of my face felt like severe sunburn; the redness was on the cheek all the way to the hairline and down to my chin, hot to the touch, and painful; after washing my face with Cereve and applying cold compress the redness subsided

                              11/17/03 - Did not use Mirvaso but around 7-8pm the right side of my face again felt like severe sunburn; the redness was again on the cheek all the way to the hairline and down to my chin, hot to the touch, and painful; I again washed my face with Cereve and applied cold compress

                              11/18/03 - Did not use Mirvaso; at 10am the right side of my face again feels like severe sunburn; the redness is on the cheek all the way to the hairline and down to my chin, hot to the touch, and painful; I am at work so I'm having to suffer through it for now

                              Comment


                              • Brady,

                                I don't know about the other drugs you mention, but I will speak to the use of accutane. There are many reports of people having very positive experiences with it and it can be a life saver. There are many very negative experiences as well (usually related to high doses). But positives are way better than 5% on the acne forums. And accutane induced rosacea can be very real, but that is a side effect for the intended treatment of cystic acne. Otherwise, you should be reporting of low dose accutane which can help rosacea (not high dose accutane for cystic acne that leads to rosacea - two very different animals).

                                The other distinction is that accutane has (and always had) very severe warnings. Prescriptions are taken very seriously and it should only be done in extreme cases (not handed out like candy as in the case of Mirvaso). So with regard to what linked about accutane, I don't see any relevance. Either compare high dose accutane pos/neg or low dose accutane pos/neg. A side effect of rosacea with high dose accutane does not fit at all.
                                Last edited by hozer2k; 18 November 2013, 06:38 PM.

                                Comment

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