This is a new letter to the editor that I wrote, in the journal Headache; these newer CGRP meds are marvelous for many patients, but the true side effect profile is just evolving:
(LETTER FROM THE JOURNAL HEADACHE, JULY, 2019: LAWRENCE ROBBINS,M.D.)
Erenumab, the first of the calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) for preventing migraine, is usually referred to as “safe.” 1 Panels of physician experts often minimize the side effects. Our literature is replete with descriptions of the mAb studies, which resulted in almost no adverse events. 2-4 The other CGRP monoclonal antibodies (fremanezumab, galcanezumab, and eptinezumab [awaiting Food and Drug Administration (FDA) approval]) are also widely regarded as having minimal side effects. However, the “real world” experience with erenumab is quite different. As of March 31, 2019, the FDA Adverse Events Reporting System Public Dashboard listed 10,531 total adverse events for erenumab. Of these, 1460 were considered serious – some life threatening. This was after only 10 months of use. These high numbers eclipse those listed for onabotulinumtoxinA. For all uses, adverse events reported for onabotulinumtoxinA totaled 33,372 between 2002 and 2018, an average of 2086 events per year. We are only discussing short-term problems due to erenumab. Long-term side effects remain largely unknown.
This author has personally communicated with many “high prescribing” headache providers regarding their experience with erenumab. Most feel that constipation is a common occurrence. For some erenumab patients, the constipation greatly diminishes quality of life. Very few of these high prescribers officially report the “mild or annoying” adverse events. Many have encountered at least one serious side effect. To be fair, there are headache providers who state that they rarely hear of any side effects.
My patients have reported a plethora of side effects. 5 Constipation has occurred in 20% of these patients. Other side effects encountered have been nausea (7%), worsening headache (5%), fatigue (5%), depression (3%), and joint pain (3%).
Four of our patients have experienced a serious side effect that was likely related to erenumab. These 4 include: A 31?year?old woman with severe neurologic symptoms, including hemiparesis. She also suffered from severe fatigue and joint pain. Her work-up was negative, and she slowly recovered; a 21 year old woman, with a history of hemiplegic migraine (no events since 2015), who suffered a probable migraine?related stroke. She reported dysgraphia, which has improved by 80% over 6 months; a 65 year old woman with a history of rheumatoid arthritis, who reported suffering from severe fatigue and joint pains, which eventually resolved on Prednisone; and a 60 year old woman with reversible cerebral vasoconstriction syndrome, which resolved without a cerebral infarction.
I have monitored various online patient migraine chat boards. Many of the patients have experienced an excellent response to erenumab. However, a significant percentage of patients describe mild or moderate side effects with erenumab. Severe adverse events are also commonly reported. It is generally accepted that online patient reports are not always reliable. Even still, when I compare the online patient comments regarding erenumab to those of onabotulinumtoxinA, there is significantly less reporting of side effects from the onabotulinumtoxinA. This matches my clinical experience.
There are many theoretical risks from blocking CGRP. 6-10 Evolution has deemed CGRP to be an important substance in virtually every organ system. In the limited number of patients studied, the use of erenumab over a number of years has not resulted in long-term adverse effects. However, we will only know about long?term effects in 10-20 years.
The CGRP mAbs have not been studied in patients who are under significant stress. During stress, CGRP plays vital roles. CGRP also is located in the pituitary and hypothalamus. The blood brain barrier does not protect these areas from mAb penetration. Before testing these antibodies in adolescents, hormonal studies should be accomplished.
Using the available information, I would “guesstimate” that the risk for a serious adverse event is approximately 0.5% of patients. It appears as if most of these serious events resolve over time. The “non-serious” side effects, such as constipation or worsening headache, are often disturbing to a patient’s quality of life. This letter focuses on erenumab, which was the first mAb on the market. It is too early to assess risk from the other mAbs.
When we discuss risks vs benefits, patients deserve more than to hear “it is very safe.” We should include the possibility, although remote, of incurring a serious side effect. Erenumab has been life changing for tens of thousands of migraineurs. I am grateful to the companies for bringing these to market. With that, we must be open with our patients about the possibility of side effects.
Well said.
Thank you. Now to communicate this with practitioners.
As always thank you Dr. Robbins. Your article brought to light the under-reported side effects that in a particular patient may be unacceptable; the trade off not beneficial enough. For me my stress level is one variable that directly correlates to my migraine frequency & every day pain level. The risk of this being thrown off — even just for a few days / weeks — would take me months to correct. In addition I admire your non-alarmist perspective & your positive support for the many migraineurs who have benefited!
thanks Ross…..LR
Thank you, Dr. Robbins for this article and for being proactive. I was prescribed Aimovig 140mg for my chronic intractable migraines with aura. I was told there were two side effects, both minor- constipation and injection site irritation. Because migraine with aura does involve some degree of increased risk of stroke and because my migraines were 30 days per month and because side effects were so minor, I agreed to try Aimovig. Eleven days after dose 1, I vomited for nearly 5 hours from a migraine. I hadn’t vomited as a result of migraine since I began Verapamil as preventive several years prior. In fact, Verapamil decreased the severity of the migraine headaches and fully stopped my migraine vomiting. I took one more 140mg Aimovig dose in January 2019. I have been suffering every single day since and am wondering if I developed an immune response. Injection site stinging pain (the pain experienced not when the needle went into the skin but, instead when Aimovig was distributed into my thighs) remains 24/7/365 since then. My legs buckle at times when I walk or stand. Shortness of breath is extreme including when I brush my teeth. I have seen a cardiologist and a pulmonary specialist and have many tests run. Both doctors believe Aimovig is the reason for the shortness of breath. This is based on examination and test results combined with understanding of CGRP and its role within the affected systems. My Raynaud’s has worsened, I developed ance (acne took a couple of months to resolve with the use of Retin-a), I developed GERD and sharp pains in the stomach organ after 2 doses of Advil. Given ibuprofen and its impact as a Cox 1and 2 inhibitor and the role of CGRP within the stomach, my GP told me to take Nexium and to try to avoid Advil. He acknowledged that some of my migraines were so severe that I had to take Advil to reestablish my peripheral vision due to migraine. My GP was frustrated that there is nothing listed about risk of combining Aimovig and ibuprofen. I have joint pain and stiffness which makes bending and then straightening difficult and painful. Nausea is very, very frequent and I was prescribed Zofran to be taken at onset of that severe nausea that now occurs every time a migraine is triggered by barometric pressure changes and/or rain. I have had 9 migraine episodes in which vomiting couldn’t be prevented with each episode lasting at least 3.5 hours. Nonstop. I have had to relearn migraine symptoms. Whereas in the past, for the 40+ years I’ve had migraines, eye twitching and face and fingertip numbness meant I’d have an aura, those now precede every migraine that causes violent nausea. Zofran is always with me both in my nightstand and in my purse. I have very loud tinnitus in my right ear. I saw an ENT about it. He noticed that my balance was also off. I told him that Aimovig was in my system. He asked if the balance problem and tinnitus both began after the doses of Aimovg and I answered that they had. I developed constipation that lasts up to 3 days, non-migraine headaches, non-cardiac chest pain, EXTREMELY painful muscle spasms in my upper abdomen, mid back, upper trapezius muscles and my thighs. In case it’s relevant, Aimovig was only injected into my thighs, not into my abdomen or upper arms. The muscle spasms in my abdomen produce so much pain, put pressure on my stomach provoking non-migraine nausea. I have noticed that wounds take longer to heal and they don’t heal the same (I have a picture of a minor wound on my finger – no scab formed on most of it, the skin didn’t come back together of the top layers for more than a week and a half). I have had significant hair loss with chunks of my hair coming out into my hands in the shower. Chunks. There are several very thin areas on my head. My quality of life is worse than it was prior to Aimovig. I didn’t think anything could get worse than chronic intractable migraines but this is awful. I can’t walk my dog more than one block, I hold onto the counter while brushing my teeth and loading the dishwasher because I become winded, the muscle spasms hurt so bad, the tinnitus is so loud that I always have background noise or I can’t sleep. The nausea has made me fearful to go anywhere because onset is so fast. Worst of all, I don’t know if or when this will stop or if any of this is permanent and that’s causing fear, anxiety and depression. I am having bloodwork soon to look for a specific immune response. I would gladly have back my old nonstop migraines. The following is unrelated to my side effects but, it might be relevant: I had multiple rounds of Botox years before I was prescribed Aimovig. I did well at 200 units Botox in that it fully stopped all migraine headaches for 2 months after each dose. However, it didn’t prevent my other migraine symptoms. My insurance changed and would only cover 30% of Botox making it unaffordable. The insurance company did add Aimovig to its formulary with out of pocket of $100. For some reason that the insurance company will not share with me, it now refuses to cover Aimovig but does cover the competing CGRP antagonists.
Thank you for sharing…these drugs can be great, but have serious possible side effects…..
Thank you for your thorough explanation. I too have daily migraines. After reading this, it made me realize that I know what I have now and it is tempting to try something else, but now I am afraid. And rightfully so. I also have tinnitus. And joint and muscle pain. I gave up wine drinking and now Im walking much better. Hils were so painful I could barely walk some days. I take Maxalt 10 mg everyday and some days 2 pills.
Did your back pain get better over time?
It’s about 4:30A and I’m up thanks to core spasms. They are incredibly painful. Beyond the pain, I’m afraid because I’m now more than 2 years since my final dose. My injection sites in my thighs also continue to sting on a daily basis. Additionally, the nausea that began to occur with most of my migraines while on Aimovig also remains. I had to take two doses of Zofran yesterday. This is one of the most upsetting aspects. Prior to Aimovig, I hadn’t had nausea due to my migraines for more than ten years. Verapamil controlled that as well as reduced the frequency of excruciating migraine headaches. My doctor increased my Verapamil since Aimovig with the hope that the higher dose would again bring the nausea under control. But it hasn’t. I am angry that the migraines are worse. If Aimovig didn’t do anything I’d consider it a pricey lesson. But the fact that it made my migraines worse and continues to cause core spasms and stinging injection site pain is unbearable. I don’t set foot outside if it’s raining, snowing or a storm is on the way because I know that almost immediately I’ll become nauseated from an instant onset migraine. I’ve become anxious and fearful of the nausea and the muscle spasms. The pain in my upper abdomen and around to my back during the spasms feels like my ribs are being crushed. I’m very afraid that I’m more than two years out since my last dose because what if this is permanent? The newer Aimovig commercials mention muscle pain. That doesn’t begin to describe what I experience. You can actually see my upper abdominal muscles twitching and my mom and doctor have both felt the spasms by putting their hands on my stomach. I sat in the exam room, writhing in pain and they agreed that it felt like the muscle contractions a woman experiences lower on her abdomen during labor. I can’t possibly do more than beg people to please look at the company study report – not the prescribing info. It is unbelievably unethical not to list in the prescribing information all the side effects experienced by people in the study. They note that they chose not to include side effects if the difference between placebo and the 70mg and 140mg doses were less than a certain percentage point. But, they have no qualms calling the doses successful with so little difference between both 70mg and 140mg against placebo. That aspect is also frustrating. Every time Aimovig and the other meds in the category were discussed on news reports, they were referred to as ‘game changers’ for the millions of Americans who suffer migraines that aren’t well controlled by other classes of medications. But the data itself doesn’t bear that out. Patients and insurance companies are paying a lot for meds that, at the higher dose, only beat placebo by about 2 days. So, for example, a test patient might experience 4 fewer migraine days per month on placebo and 6 fewer migraine days per month of 140mg. The overall benefit is 2 days compared to placebo. Is that worth the financial cost and the risk of long term debilitating side effects? I belong to an online private migraine support group. One woman has now injected herself 8 times with 140mg Aimovig and is experiencing side effects, has no migraine control during her period, no migraine control when she’s under stress and no migraine control when the weather is bad. But she’s invested a lot of money in copays and a lot of hope so she’s not ready to say the medication has failed her. I no longer ask her to please rethink what she’s doing. But the others in the group have had similar experiences that I have and all discontinued as well. Some opted to try the competitor meds hoping they might work better with fewer side effects. A few have reported back that those meds work a little better for them. The rest stopped the competitor meds as well. Migraines are complex. I get why blocking CGRP was thought to possibly short circuit the process involved with migraines and I’m sure an enormous amount of money was spent by all the pharmaceutical companies who produce this class of meds. But post-market data across the board most definitely shows that they are not the game-changing wonder meds that they were expected to be; at least not for the vast majority of migraine patients who have been prescribed them. Beyond that, I worry how many people decided to try these meds because they’ve been told that there are only a few side effects. That should defy reason when you think about it. When was the last time you saw a commercial for any prescription medication with only two or three side effects listed? Rant over. It’s past 5 am here and typing while twisted half on my side, half on my back as I try to find a decent position, least painful during these core spasms isn’t working well. I wish you well.
Thank you sincerely for your comments. It disgusts me how devalued patients are and how the almighty dollar reigns supreme. I’ve watched, and pleaded, as not just my own life has been stolen from me, I’ve been subjected to torture over and over, but also the masses who are misfortune enough to trust in the medical system, the government and society as they are sacrificed merely so that others can profit and never admit any folley. Even the atrocious war on drugs has been obfuscated in such a way so that the public wouldn’t ever figure out that the government, medical system and society are responsible for the “epidemic”, for the death toll ballooning to ten times what it was before war against people. Drugs are inanimate; they don’t fight. And in fact the deaths being attributed to drugs are largely due to the stress of the war. Without the war, there wouldn’t have been the deaths and overdoses, accidental or intentional. That’s not to say that truthful education isn’t necessary. But everything is slanted and spun to create a villain and feed an agenda rather than tell the truth.
I believe that one of the ways to help straighten out these injustices is to create a patient lobby group to represent patients rights and voices in government. I rarely have the capability to even write or communicate, but somehow, some way, eventually, I need to find a way to make this happen if we are going to make some headway. There are more people affected by chronic illness and/or chronic pain in the community than not. Literally, more than 50% of the population, so we have the numbers. Food for thought.
At the very least, know that I feel for you and recognize that what happened to you happens much more than even you realize. I don’t want to say too much however.
Melissa, Thank you for your honesty in your post. I know it’s been a year and I hope you are feeling a bit better, I truly hope. I took the Amovig 70mg shot in April and within a few short days my life has changed as has many others with the same symptoms. I am tired of trying to explain to my family or neurologist, I just went back to botox. I’m sorry I decided to try this drug. I am still not the same and everyday hoping today will be the day I will feel normal again. I feel robbed!
Load note an top-level stakes seeking your team. chicagoheadacheclinic.com
http://bit.ly/2NLzKM8
I can appreciate your pain, Melissa. This medicine has destroyed my life. I was willing to switch to it based on the limited side effects listed. Worked for what seemed like a month or so….then the slide downhill. But not one Dr. acknowledged this medicine as the problem and put me on other meds, claiming other potential health issues, since no side effects were listed for it. After close to 2.5 years, my own reaearch and a bad health episode that landed me in the hospital….my Drs. finally listened to me and acknowledged it was this medicine. I stopped it March 8th. I am still suffering and fear permanent damage. Absolutely awful.
Just awful to hear that. I turned it down. Magnesium helped mine and so happy it did. Hope you move toward better health. Word needs to get to docs fast.
I think these CGRP injections should be on the market BUT people should be made aware of some of the common side effects; patients deserve to be able to make an informed decision….
Last fall, my doctor told me about Emgality. I decided, because I was told there were very FEW and mild side effects, to try the shots.
My 1st month was great. For the first time in years I had only two to three migraines that month! I was ECSTATIC. Though the medicine wore off by the 3rd week, I agreed with the NP whom I saw at my next appointment to continue with the med, with the hope that building it up in my system would be the most beneficial, since I had such positive results.
I cannot tell you how much I’ve regretted this decision after 4 shots! I began experiencing a variety of symptoms that I did not connect to the medicine until later, after reading patient reviews online. That was my ah-ha moment.
This medicine has destroyed my life.
OVERWHELMING fatigue, sleeping up to 20 hours a day.
My chest feels funny; not pain exactly, but not normal, either. Rather a heaviness of sorts. Constant sore throat.
I have hot and cold flashes. (The hot flashes are not just flushing; they are me dripping sweat).
My neck and head hurt so badly I pray to just die and get it over with. It’s the worse pressure I’ve ever felt, 24/7. I’ll take migraines any day over this.
Extreme pain in my left shoulder (to where I can barely lift my arm), as well as my left knee, (I have difficulty lifting my foot, thus difficulty walking). I’ve NEVER had joint pain before. I’m also very off balance at times. My thoughts became increasingly confused and DEPRESSIVE, though the confusion is resolving, slowly. (I’m normally very optimistic. I am still depressed, but I logically attribute this to the cgrp effect on my brain.
I’ve lost my appetite, and despite forcing myself to eat, usually under 1k calories most days, I’ve gained over 20lbs.
These are my major symptoms, though i have had some uti’s and developed persistent, loud ringing in my ears.
I do know my doctor reported only TWO symptoms to FDA, though I’ve described them all to him.
I only pray this medicine’s effects wear off soon. I literally feel like I am slowly dying. I understand from my research there is a 5 -6 month half-life with these meds. After a 3 month trial, ending this past Jan, I am still suffering severe side effects in May. I am back on triptans, which help to ease the now constant headache.
At the very LEAST the FDA needs to update their pamphlet info on these drugs, including ALL the detrimental reported side effects.
I am sorry to hear, these are very serious side effects; the initial studies did not identify these, and now we are discovering…..
I am just 2 weeks past my first injection and I’m too exhausted to get out of bed. I have fibromyalgia but in all the years I’ve had it I have always been able to get up. Now that I look back, I realize that the muscle cramps I started to experience when walking within days of the injection were a side effect of this drug. I thought I had just gotten too little exercise. My muscle and joint pain are increasing daily. The muscles in my chest are tight making me feel short of breath. I’ve had no constipation. I’ve started having bizarre dreams and angry outbursts. I have tremendous regret for taking this medication. Suffering from fibromyalgia I should have been more wary that I would be more likely to have my symptoms worsened. All I can hope is that the side effects start reducing as the weeks go by. I wish the half-life was much, much shorter.
I get severe Cluster headaches, was looking forward to these injections but a little wary,Injections worth a months Meds sound scary to me if you have a reaction then you are stuck with an overload of it in your system, for that reason I was gonna try the oral CGRP first to test it out and would hope any smart Doc would start it slow that way, for me ambien works wonders since my clusters are nighttime occurence,however my Doc acts like Ambien is the bigger evil compared to CGRP blockers, I am trying to follow my gut instinct and wait out for more research.
yes these mAbs could help clusters BUT they do carry the risk of side effects, much much more than were revealed in the official studies; and Ambien is ok, its just that we try other, non-habit forming meds first; and of course the “Sleep Rules” outside of the meds….
I was so ecstatic that Aimovig took my chronic migraines from 20 per mo to -0-. But noticed during the 8 mo since I began injecting that I still have the visual aura, just no pain a couple times a month. However, I paid this no mind since I had no pain. Then the 27th of Jan after my 8th injection I had 4 auras in just 5 days. On the 6th day I was rushed to the hospital with (my first ever) seizure. It was serious and they kept me overnight. They were sure I’d had a stroke. I did not. Thankfully it was only the seizure but it was serious enough that I’m now on Keppra and can’t drive for 6 months! I’m 66, I’ve had these migraines for 52 years. The only thing that changed is Aimovig. I can’t help but think, with the auras, and the addition of the Aimovig that it had something to do with the new onset focal seizures. Anyone else?
yes there are many many side effects that are occurring, and patients need to be aware….
Thank you to all for your input. I’m a 62 yr old woman who has suffered with migraines most of my life. Have tried everything without much relief. Neurologist suggested Aimovig 3 months ago. First 2 months felt like I had my life back. Noticed the last week before next injection would start getting migraine, not as severe. After 3rd injection, started aching next day, severe fatigue, sore throat, extreme heaviness in my chest, joint pain, pain in shoulder. I’m an asthmatic. Got to where my inhalers had no effect. Began to think I had COVID-19. Ended up in ER. Thank goodness no Covid-19. But left with no real answers why, other than asthma. Had to use nebulizer several times a day. Finally, feeling better. Have really been perplexed as to what caused this. After reading this, I don’t think I will be using Aimovig in the future. Dread the migraines, but think I can deal with that better than not being able to breathe. Migraine sufferers need to know what the potential side effects are before deciding to take this. I’d be interested in knowing if any asthmatics have experienced similar symptoms.
yes, the side effects are many(as of Dec31, 2020, 41,000 side effects reported to the FDA, 5,500 serious ones); patients should know, but the problem is doctors are not aware; the PI needs to be updated…..Larry Robbins
I took this “no side effects at all” for 8 months. Twice I became so constipated I thought I had to go to the ER. I had no idea this was drug induced. I have had GERD for years and some loose stools with dairy and salads or food poisoning. But never constipation My loose bowels stopped immediately after taking this drug by injection and I wondered what was up with that. But no side effects both my Neuro and intern said. After the second episode I started to read. Colons taken out, esophagus not working, that was enough. I stopped. I also had whispering bowels or whistling which is a sign of blockage. I thought it was a new pillow as I could not localize the noise. After stopping I had another episode shortly after and ended up at the ER. This is a dangerous drug and unnecessary, At 9600 a year for life it is obviously a big money maker. Try triptans and narcotics. They work for about 65 a year. Take them and nap and 90 percent will be fine.
these monoclonals have alot of adverse effects; as of 12/20, there were 41000 side effects reported to the FDA, 5,500 serious ones; this is not unique to these monoclonals; many drugs come out with a relatively clean PI, only to have thousands of adverse events reported a year or two later; we have to change, mostly thru the FDA, how side effects are aquired in clinial trials….
Please see your internist. Aimovig can have an impact on the cardiovascular system. Between the fatigue, which could be that not enough oxygenated blood is getting where it needs to be, and that the change in position could be blood pooling in your legs, you at the least need to see your GP. I am, at the moment, wearing a cardiac event monitor. I developed tachycardia and the cardiac electrophysiologist is trying to determine the kind. My initial report of being breathless while brushing my teeth has worsened. The cardiac electrophysiologist increased my calcium channel blocker which was prescribed to me for migraine prevention. Even at the 360mg prescribed to control my migraines, my resting heart rate hit 80. As I mentioned, I’m wearing the cardiac event monitor. It will be on for 10 days. The doctor told me to increase my fluid intake to 1.5 – 2 liters of water per day and to add electrolyte tabs to not wash out sodium. And, because this is regarding those of us with migraines, I’ll add that the doctor will be conducting an echocardiogram with Definity. For approximately 20 years, it has been thought that there could be a link between migraines with aura and PFO. The FO, or foramen ovale, is the hole in the wall between the left and right atria which is normal in a fetus. It should close a few months after birth. When it doesn’t fully close, it is called a patent foramen ovale. The specialist will be looking to see if there is a hole in my heart. He said that cardiac specialists now believe that this is a valid theory. Patients experiencing aura should speak to their doctor though evaluation will be done via cardiology groups. A paper available on the NIH site entitled “The Correlation Between Migraine and Patent Foramen Ovale (PFO)” explains not only how it is believed a hole in the heart is linked to migraine with aura, the statistics are stunning. What I find frustrating is that no migraine specialist even broached this topic with me. While I understand that it only recently appears to be a conclusive link, I believe this goes back to making sure your patients are as informed as possible when treating them. Given that this has been a topic since 1998, if I had the choice between having an echocardiogram versus trying a medication only tested on a couple of hundred people who fit my situation (140mg for chronic migraine), I would have chosen the echocardiogram (even if only to rule in or out a possible underlying reason for my migraines with aura). And, if there is a hole in my heart, did a CGRP antagonist put me at increased risk of cardiovascular problems? The following is from the paper found on the NIH site. While there is quite a bit of medical terminology, I think it can be understood by laypeople. Again, if you are displaying cardiovascular symptoms, you must speak to your doctor and please never ignore the symptoms. Here is the snippet. I hope this helps inform someone with aura of what should be discussed with your doctors: “Through the PFO channel, venous blood can enter arterial blood by shunting without circulating in the lungs. Some chemicals and hormones such as serotonin can bypass the pulmonary circulation and pass directly through the blood-brain barrier to cause migraine. Moreover, a tiny embolus in the systemic circulation can pass through the PFO and directly into the arterial system. These ‘paradoxical embolisms,’ which lead to tiny brain infarctions, triggering low perfusion or cortical spreading depression, may cause a migraine attack, and could be the most probable pathophysiological mechanism on how PFO could lead to a migraine attack. This hypothesis can also explain the use of antiplatelets or anticoagulants and atrial fibrillation ablation for relieving migraine attacks… Among migraine patients, the incidence of PFO is 46.3-88% in migraine patients with aura…”
Lauren – I am so terribly sorry for how you’ve suffered. I think the most difficult part of this is that we were told this could help us. Instead, it left us in much worse shape. It boggles the mind that a drug that interferes with CGRP throughout the body does not contain substantial warnings on the box. I suppose that really only happens with drugs like Accutane. But, CGRP is critical to normal function of things like protecting stomach lining, wound healing, etc. So, consequences would seem obvious. The most concerning would be risk to the cardiovascular system. When the pharmaceutical company’s own employees state their concern for that system, one would think doctors would be informed of risk. For me, the need for Zofran on a daily basis in order to prevent vomiting from migraines since Aimovig entered my system is particularly hard to deal with. I lost physical strength because I became winded easily. Even moderate exercise left me gasping for air. It boggles my mind that something meant to reduce the frequency and/or severity of my migraines made both worse and took more from me. Of course chronic migraine patients are desperate for help and better quality of life. But, that leaves us exposed to risk when the newest class of meds was spun as game changing with few, minor side effects. Unless a patient has a very well informed doctor, a provider who does his or her own digging into what has been revealed post-FDA approval, that patient will sign up for something that can remain in the body for a long time with effects that can’t be reversed during the course of time that it remains in the patient.
Lauren, I hope you will go back to how you were before the medication. I have tried not to focus on the fact that I still have side effects, long after Aimovig left my body. But, I’m now 2 years, 4 months since my last dose and I continue to have stinging sensation at each injection site, the aforementioned nausea will all my migraines, core spasms, thigh spasms, shortness of breath, etc. At one point is this list considered to be permanent? I want to be able to go beyond my doorway to let my dog out (on his retractable leash). I want to stand outside with him regardless of the weather and not become instantly nauseated and lose my peripheral vision from an instant onset migraine. I want to walk him around the block without stinging in the injection sites and my thigh muscles going into spasm, let alone becoming winded. My life was difficult prior to Aimovig. Now I have to take Advil more often and Zofran frequently. Never ever would I have signed up to try a drug that can create awful side effects and that remains in the body for a long time. This class of drugs is bringing a lot of money to the manufacturers via private insurance, Medicare and Medicaid. They raced to the finish line. I didn’t sign up to be a test patient. But, for all intents and purposes, that’s exactly what I have become.
yes these CGRP monoclonals have significant potential side effects; but to be fair for alot of migraineurs they ahve been excellent, it is a mixed picture; problem is, doctors dont know about the adverse effects, and neither do patients
I have been on Emgality for 2 months. My migraines are much fewer and less severe but I have developed constant and intense acid reflux. Besides briefly during pregnancy, I have never had acid reflux before taking Emgality.
It may or may not be the Emgality; I would definitely suggest consulting a GI doctor….Emgality does, as with the other mAbs, result in a plethora of side effects…..
I had my first 2 doses of emgality 3 weeks ago. immediately got a rash on the ankles and elbows ,burning ,itching all day. Took antihistamines for 5 days. I now feel pressure at the back of my head, anxiety and shortness of breath. I won’t be taking this anymore !!
So I just took my third Aimovig injection last month. Two 70s and now a 140.
Several thoughts: first, for me, it seems to work. My chronic, 24-7 migraine is now much more sporadic. Meaning I’ll now have 3, 4, 5 days in a row where the headache is now only a 1 or a 2. Big improvement, at the moment.
Having said that, there’s every chance that was my last injection. Why? For me, the side effects are substantial.
Constipation? Nah, fortunately. I’m active, and magnesium/fiber/water takes care of the rest.
So, next is dizziness. It happens when I change position fast, esp getting up at night. But – I take it slow, wait till the room stops moving, and in a few seconds I’m good. Unsettling, but not a deal breaker.
And then – fatigue. Now we’re getting serious. I’m used to bounding up stairs. Now, I pull myself up by the bannister because my legs feel wobbly most of the time. For a fitness freak, it’s disturbing. And there’s a mental lethargy that makes it hard to get up and get started on things. It feels like Topiramate lite. Though lately, not so lite.
Last and most recent – muscle spasms. Hands, and from the knees on down. And this isn’t just a matter of stretching out my calves. Flexors and extensors are equally affected, so I’ll stretch out a calf and the shin locks up. And vice versa. Try to sleep with that going on. This has been near constant, the past week.
I’m seriously debating whether to take that next injection. And I can’t believe I’m saying this, because for me it works. And I’ve tried ’em all, almost. But now I’m wondering what else might be going on behind the CGRP blocking. The somatic symptoms are the obvious ones. Now that I’ve started reading, the thought that dozens more non-somatic physiologic mechanisms may be impacted is sobering. Hell – it’s terrifying.
If the side effects don’t fade, I’m done with this. I’ll keep looking for the best abortive. I didn’t sign up for this.
those are all possible side effects…..it is risk vs. reward, whether the benefit justifies all of these adverse effects……
Risk v reward is indeed the question, Doctor. Unfortunately we seem to be largely dealing with anecdote, at present. So we who experience these ancillary symptoms have no idea if they’re temporary, or permanently linked to ongoing CGRP inhibition. All we can do is trade notes on these forums. Not very scientific. But thank you for providing the venue.
Gene Schiappa – I meant to direct my response last night to you. But, I think it didn’t go under your comment. If you haven’t spoken to your GP about possible cardio symptoms, please do so. I’m continuing to have tachycardia episodes and my severe core muscle cramping/spasms still occur from time to time more than 2 years after my final 140mg dose. I haven’t been able to take my dog on a proper walk (longer than half a block) since my symptoms began. If you already read my response from last night, please disregard this one. I am concerned about your fatigue.
Hey, Melissa. I’ve been here a week and you’re already famous in my mind for the fantastic ordeal you’ve undergone. My heartfelt sympathies.
I do get the occasional tachycardia. But I’ve been a little cardiac-irritable for years, and this doesn’t feel any different. I’ve had a few A-fib episodes over the years, so I know exactly what cardiac inadequacy can feel like. This isn’t that, thankfully. It’s a spent feeling that resides mainly in my legs and makes me want to fall asleep all the damn time.
The horror show you endure makes me feel embarrassed for opening my mouth.
My GF is a PT, and she suggested moist heat might help those spasms. It felt ridiculous in the middle of 90 degree days, but by God it did help. A lot. Not sure how you might apply a heating pad to your midsection, but it could be worth an experiment. We have nothing to lose but our triple-damned side effects.
Dr. Robbins,
I will say that I have a complicated medical history, and this year has been one for the books. In 2020, my neurologist and I attempted Emgality for a total of 5 shots starting 12/31/2019-04/19/2020. I have CVID and am on SubQ IgG, and had hesitated to take another antibody that runs along the IgG pathway. Unfortunately, I had the flu the first week of Feb (no, it wasn’t COVID) and then developed an acute sinus infection for 8wk with migraine. My neurologist ended my time on emgality due to many of the side effects you outlined in your PPM article in 2019 about the missed opportunity in the phase 3 trials. I understand that it takes 6 months for Emgality (galcanezumab)to work out of someone’s system, and that place me at the the end of October 2020, possibly later due to my myriad of issues. At the end of December I developed a Fever 100.0-104.0 with cough and congestion, not COVID X3, or bacterial infection, or viral. All were tested for and nothing significant came out, and I am still having fevers nearly daily over 100.0 -101.5. To complicate matters, I have been in a constant migraine since 07/07/2020, but it started in May with severe muscle spasms in my L back, shoulder and neck. I still have those spasms even on muscle relaxers. They I feel are my primary trigger for this continued migraine, but a 1000 other issues do not help. 4/10 with my abortives has become my new normal, I am aware of every thing I am doing, and my providers support what we are doing doesn’t fit most EBM guidelines.
I know this is the longest Hail Mary in the face of everything, but I am going to take every chance… with what you said “ The CGRP mAbs have not been studied in patients who are under significant stress. During stress, CGRP plays vital roles. CGRP also is located in the pituitary and hypothalamus. The blood brain barrier does not protect these areas from mAb penetration,” and my apparent sensitivity to the maBs. Could this FUO be an adverse reaction to those medications? We have tested everything. My MRI wmhs are stable, and there are no physical changes visible to the hypothalamus or pituitary. I am resigned to not knowing a cause, but this article made me think.
Any thoughts are welcomed, I understand if you cannot make any comment. I will likely be discussing this with my immunologist, neurologist, and likely the providers at the MUSC Headache Clinic when I see them in the fall for a second opinion/consult at the request of my neurologist if the idea holds any merit. Thank you for your time and attention.
So, a followup to my post on July 5. I don’t know if people are even on this thread anymore, but I like a little closure.
I had 3 injections – which worked, my chronic 24-7 migraine was dissolving before my eyes. But the side effects were seriously debilitating, to where I was debating whether to take that 4th injection, or scrap one of the few meds that really helped.
Long story short, I’m out. It’s been 6 weeks since that last 140. Headaches are returning, but that miserable fatigue seems to be slowly lifting. Muscle spasms are still bugging me – I had a day behind the wheel where both arms and legs were twitching and knotting up on me. Not recommended for a long life. But lately, that’s also better. Dizziness is actually somewhat worse. And now, 6 weeks out, it’s accompanied by nausea.
One quick aside: I’m not suggestible. I didn’t read up on these forums and then mysteriously acquire these symptoms. I got them first, then started reading. And I now believe there’s something bad going on here.
My doc suggested a switch to Ajovy. I’m holding off. For now, I’m back on abortives, and that’s another thing – triptans don’t work for me like they used to. But CGRP inhibition has started to feel intuitively dangerous, at least for this susceptible minority. I can’t shake this awful feeling that significant, lasting damage is possible. There’s no data available yet that IDs mechanisms. But this stuff now feels very wrong to me.
That’s my Aimovig experience. For whatever it’s worth.