New Flu And Migraine Drugs Approved By FDA On Scant Scientific Data, Raising Concerns: Report

According to a new report that looked at emerging safety risks linked to the flu drug Xofluza and three migraine medications, Aimovig, Ajovy and Emgality, federal regulators may not have required robust enough clinical trials before approving the medications for use on the public.

The Institute for Safe Medication Practices (ISMP) issued a QuarterWatch report last week, which indicates that the U.S. Food and Drug Administration (FDA) should have required more in-depth clinical trials on a number of new medications, instead of leaving their safety profiles up to post-marketing surveillance, which some critics say uses the public as guinea pigs.

One of those drugs was Xofluxa (baloxavir marboxil), approved by the FDA in October 2018. It is the first new antiviral treatment for influenza in almost 20 years, and is marketed by Genentech. However, the report notes that the FDA approved Xofluxa after it had been tested on only 710 patients.

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The third, and most crucial phase of testing only involved 113 patients in North America, of which only 18 were African Americans and only 32 were Hispanics. The racial differences may be important, because there is evidence that the benefits differed between Japanese and North American test subjects.

Since the drug was approved, there have been at least 50 cases of potentially life-threatening allergic reactions reported to the FDA’s adverse event reporting system (FAERS), including three deaths. There have also been reports of central nervous system problems, and gastrointestinal complications. Most of the reports came from Japan, where use was more widespread.

“Given that potentially millions of people might be exposed to a new flu treatment, the limited clinical testing for FDA approval left questions unanswered about both benefits and risks,” ISMP researchers warned.

ISMP researchers reached out to Genentech, which confirmed it has seen a safety signal for hypersensitivity, including anaphylactic shock, and is currently monitoring the reports.

Benefits of New Migraine Drug Class Highly Variable

The ISMP also looked at an entirely new class of migraine biological medications, including Aimovig (erenumab-aooe), by Amgen, approved in May 2018; Ajovy (fremanezumab-vfrm), by Teva Pharmaceuticals, approved in September 2018, and Emgality (galcanezumab-gnlm), by Eli Lilly, which was also approved in September 2018. All of the drugs block the effects of a signaling molecule believed to play a role in migraines.

“One striking feature of these new products was large variability in their effects. The results ranged from no effect in some patients in reducing migraine days, to others who reported treatment eliminated–or nearly eliminated–migraine headaches,” the researchers wrote. “The early adverse event data showed that erenumab-aooe also had adverse effects, some apparently underestimated in its clinical studies.”

On the benefits side of things, the ISMP report notes that even the clinical trials showed a substantial placebo effect, meaning patients who received a fake pill reported fewer migraines, even though they were not actually given any medications.

However, adverse event reports included constipation, sometimes up to the point of hospitalization, as well as hair loss, injection site reactions and rare cases of anaphylactic shock.

“The most striking feature of the (Aimovig) adverse event data was the sheer number of case reports in our totals for the 12 months ending with 2019 Q1. We identified 10,508 case reports, including 1,458 with a serious outcome,” the report warns. The drug ranked first in number of reports for 33 new drugs approved in 2018 and accounted for more than twice as many cases as the other 32 new drugs combined.”

36 Comments

  • KathyMay 7, 2022 at 3:33 pm

    I took the loading dose in Nov of 2019. I was so excited, as I had no migraines for 3 weeks. They came back with a vengeance in the fourth. The second shot I did at home. Within a day or so, I began a headache that started, bit seemed, in my upper neck, spread up the back of my head, and then turned into a full-blown migraine. This was accompanied by muscle and joint pain, SEVERE tinnitus (ongoing[Show More]I took the loading dose in Nov of 2019. I was so excited, as I had no migraines for 3 weeks. They came back with a vengeance in the fourth. The second shot I did at home. Within a day or so, I began a headache that started, bit seemed, in my upper neck, spread up the back of my head, and then turned into a full-blown migraine. This was accompanied by muscle and joint pain, SEVERE tinnitus (ongoing) and the worst fatigue I've ever felt. I became bedridden for EIGHT and a half MONTHS. CONSTANT headache... Different than migraine, but still so painful I prayed to just die. I lost my sense of smell and taste, as well as the ability to feel when I needed to urinate until it was urgent. My heart felt like it was pounding out of my chest at times. My brain feels like it has SHRUNK, as when I move too quickly, I can FEEL it bounce from one side of my skull to another. Not to mention COGNITIVE issues. Searching for words, losing thoughts completely in the middle of conversation, loss of short-term memory, and sudden and vivid remembrance of memories from decades ago. I am exhausted ALL the time. I now require at least a three or four hour nap just to get thru the evening until 6:30-7:00 p.m., when I'm so exhausted I have no choice and must go to bed. My life was utterly RUINED by Emgality. My doctor told me there were no side effects. He believed the FDA, I guess. I told him all my symptoms, but as far as I know, he only reported joint pain to the gov agency that collects info. (vaars?) After I began to slowly recover (one puff of indica helps tremendously, believe it or not, as well as sumatriptan - of which I'm only allowed 7 a month, idk why) I began to research. On the site drugs dot com, there are SO MANY ppl who have reported horrible side effects like mine and the folks here! These drugs need to be removed IMMEDIATELY from the market! WE ARE NOT YOUR GUINEA PIGS!! The company or companies who make and sell them need to be held ACCOUNTABLE!

  • LaApril 22, 2022 at 2:39 am

    Emgality Loading Dose only and no more after. 3 weeks complete bowel blockage no medication worked to relieve. Weight gain while losing (31 kg Total) at 1 kg/week interval, extreme fatigue and exhaustion for 2 weeks required being in bed 90% of 24 hours. Fatigue requiring bed rest within 1 hour of injection. Medwatch was not contacted because Emgality “has no adverse effects” [Show More]Emgality Loading Dose only and no more after. 3 weeks complete bowel blockage no medication worked to relieve. Weight gain while losing (31 kg Total) at 1 kg/week interval, extreme fatigue and exhaustion for 2 weeks required being in bed 90% of 24 hours. Fatigue requiring bed rest within 1 hour of injection. Medwatch was not contacted because Emgality “has no adverse effects” Pharmacy, LPN at neurology, poison center pharmacist and director all said it was me because Emgality has no adverse effects and refused to report to Medwatch. Tried state health department but they could not do this. Multiple phone calls, but not reported because Emgality is adverse effect free.. Thousands of patients and I was the only one. Tried to contact manufacturer but could not get through.

  • KaneathaDecember 13, 2021 at 1:11 am

    One of Aimovig nearly killed me. I’m a young healthy mother, left BEDRIDDEN from one shot of that poison with issues I NEVER had in my life before. The drug label is misleading and what’s most disturbing is they don’t disclose the long half-life of the drug, meaning one dose, one injection is not eliminated from the body for almost six months! Infuriating! They could at least be more informative! [Show More]One of Aimovig nearly killed me. I’m a young healthy mother, left BEDRIDDEN from one shot of that poison with issues I NEVER had in my life before. The drug label is misleading and what’s most disturbing is they don’t disclose the long half-life of the drug, meaning one dose, one injection is not eliminated from the body for almost six months! Infuriating! They could at least be more informative! But oh no! There’s actually very few side effects listed and it’s pushed as a “clean drug”! POISON!

  • CassieDecember 4, 2021 at 11:16 am

    Emgality is horrible and I firmly believe a class-action lawsuit is inevitable. Many patients are reporting the same adverse effects negatively impacting their health, and I do not believe that the FDA should have approved this drug without further clinical studies. After only one shot, I had very rapid weight gain, bloating, constipation, symptoms of high liver enzymes (very dark urine, itching, [Show More]Emgality is horrible and I firmly believe a class-action lawsuit is inevitable. Many patients are reporting the same adverse effects negatively impacting their health, and I do not believe that the FDA should have approved this drug without further clinical studies. After only one shot, I had very rapid weight gain, bloating, constipation, symptoms of high liver enzymes (very dark urine, itching, fatigue, nausea, abdominal pain), and weird nerve symptoms such as feeling like things were burning or boiling hot when they were only lukewarm. This shot should NOT have been approved for use on the public as guinea pigs.

  • ClaraJuly 4, 2021 at 5:33 am

    Ofcourse migraine medication effectiveness will be highly variable. All migraine treatments have variable efficacy, because there are different types and underlying neurological causes. Thats not an argument, it just demonstrates that it was written by a lawyer, not a medical professional.

  • DawnMarch 15, 2021 at 8:11 pm

    I just took my two loading doses of Emgality 5 days ago, 3/11/21. I have had such severe joint pain, and tingling in my legs, almost like electricity, ever since. Itching, insomnia, my migraine pain has almost doubled. My doctors office says this is NOT normal, but my local pharmacy says that it is. I can barely walk it hurts so bad. My wrists hurt, and lower back is horrible, and hips are sore to[Show More]I just took my two loading doses of Emgality 5 days ago, 3/11/21. I have had such severe joint pain, and tingling in my legs, almost like electricity, ever since. Itching, insomnia, my migraine pain has almost doubled. My doctors office says this is NOT normal, but my local pharmacy says that it is. I can barely walk it hurts so bad. My wrists hurt, and lower back is horrible, and hips are sore to the touch. I will not be taking another dose! I feel so misled.

  • SusanMarch 1, 2021 at 1:23 am

    I noticed the severe constipation immediately after starting Aimovig. i thought that it was a price that I was willing to pay for a drug that not only dramatically reduced the number of migraines per month, but also took the severity from 8/10 pain scale to a 2 or 3. I have been on it for about 2 years and about a year into it, the stomach pains started. The first time it happened shortly after in[Show More]I noticed the severe constipation immediately after starting Aimovig. i thought that it was a price that I was willing to pay for a drug that not only dramatically reduced the number of migraines per month, but also took the severity from 8/10 pain scale to a 2 or 3. I have been on it for about 2 years and about a year into it, the stomach pains started. The first time it happened shortly after injecting so I put the two together. The other times have been at the end of my month before the next injection. It has now progressed to me passing out and loosing consciousness after vomiting. I also experienced heart palpitations for 2-3 months but those seemed to have passed. I'm done with this medication!

  • BillJanuary 5, 2021 at 3:18 pm

    Emgality changed my life for the good. I went from 17 migraines a month to about 5 a month. The only possible side effect I’ve seen that started at around the same time is a benign lump in my breast.

  • JeanDecember 15, 2020 at 11:26 pm

    I took several doses of Aimovig and had many of the noted side effects. One not noted until AFTER I had a retinal stroke due to a sudden onset of high blood pressure attack. Finding out after the fact that Aimovig now can cause that doesn't help my damaged vision!

  • BrendaJuly 20, 2020 at 12:13 am

    I took Aimovig for 7 months, that was the only new medicine that I had been on, I woke one morning and couldn’t move my left leg, has the day went on I still couldn’t, long story short, I was almost five months before the doctors find out what had happened to my leg, I had infection in my hip which caused me to have two hip replacements, I also suffer from ringing in my ears!!

  • NatalieJune 23, 2020 at 8:26 pm

    Aimovig has done horrible things to my body. Sharp zapping, burning pain on scalp with severe hair loss. GI issues, extremely tired to the point where I had a sleep study conducted. I took only a couple of doses, last one being in Jan, when I googled Aimovig and hair loss. If anyone is building a case I'd like to participate. Please contact me.

  • LiseJune 22, 2020 at 11:34 pm

    I took Aimovig for 5 months - got every bad side effect I later learned was listed at bottom of 200 pages in trials, including UTI, high blood pressure, multiple infections, worse headaches/fatigue, confusion, anger; dermatitis, hair loss, compromised immune system: landed in ICU 5 weeks, almost died. Worst medical experience of my life.

  • JulianneMay 9, 2020 at 2:15 pm

    I took one dose of Aimovig in late November of 2018. The worst thing I ever did. I have had severe constipation, pain, stomach bloat and now full on IBS. I never had any GI problems in my life. I wish I could go back in time and stop myself from taking this.

  • ROSApril 21, 2020 at 4:29 pm

    My Wife who was otherwise very healthy and fit at 46 years old began Aimovig in October of 2018. By the spring of 2019 she was being treated for Melanoma, on one mole, then two, then in the fall of 2019 three, then another suspected mole in early winter, all for melanoma. Then in January of 2020 she felt a lump on her breast and had it biopsied, it was found as cancerous and she's stage 2 breast[Show More]My Wife who was otherwise very healthy and fit at 46 years old began Aimovig in October of 2018. By the spring of 2019 she was being treated for Melanoma, on one mole, then two, then in the fall of 2019 three, then another suspected mole in early winter, all for melanoma. Then in January of 2020 she felt a lump on her breast and had it biopsied, it was found as cancerous and she's stage 2 breast cancer, now undergoing treatment after surgery, radiation then soon Chemotherapy is necessary. We researched a trial of Aimovig after discovering the breast cancer and found 2% of women in a study developed some form of cancer but it was dismissed as not enough to determine a causal relationship. Aimovig prescription info states it has not been analyzed as a carcinogenic in the small print of the drug info. My wife was genetically tested and found to not be predisposed to cancer nor does it run in her family. Aimovig was the only drug she was taking that was new to her system over the fourteen months she was injecting, and obviously we now learned had molecular implications that it seems have resulted in her ongoing battle with skin and now Breast Cancer. Just sharing to make everyone aware that all things have not been disclosed about this drug and it may have life threatening implications.

  • JenniferMarch 25, 2020 at 3:11 am

    Have any of these complaints started a class action lawsuit for the migraine medicine Ajovy? I would like to start one as I still have not recovered and I stopped the drug in Aug 2019. Please contact me if you have any guidance for me to get this started. Thank you

  • MarcelMarch 22, 2020 at 4:21 am

    I took 2 doses of Emgality starting in April 2019 and despite immediately discontinuing, I've had severe whole body pain since where I've had to go on disability. These side effects were not disclosed on the insert nor by the doctor. No doctor can figure out what is wrong with me. This has ruined my life.

  • KatalinMarch 11, 2020 at 9:59 pm

    Horrible injection site reactions, severe constipation and hair loss, no reduction in migraines- were safety studies even done on these meds or did the pharmaceutical companies just want money?

  • MichelleMarch 11, 2020 at 8:38 pm

    Emgality triggered me to have a five week migraine. Other symptoms started around the same time that I suspect may have been caused from an interaction of Emgality with Remicade; I have had chronic diarrhea and lost over 35 pounds and have horrible itching ever since. No other explanation has been found. I had my Remicade infusion one week after my loading doses of Emgality when these symptoms sta[Show More]Emgality triggered me to have a five week migraine. Other symptoms started around the same time that I suspect may have been caused from an interaction of Emgality with Remicade; I have had chronic diarrhea and lost over 35 pounds and have horrible itching ever since. No other explanation has been found. I had my Remicade infusion one week after my loading doses of Emgality when these symptoms started.

  • ErinMarch 11, 2020 at 7:21 pm

    Hi. I was on Aimovig for 7 months. I experienced horrible rash, flushed red face abd severe itchiness to the point I'd itch and make myself bleed. It was horrible. By about the 5th month in I had weight gain and started to loose my hair. I was sad and depressed and went off the medication at the 7th month. It was a horrible experience, made me sad and depressed and It didnt help with my migraines [Show More]Hi. I was on Aimovig for 7 months. I experienced horrible rash, flushed red face abd severe itchiness to the point I'd itch and make myself bleed. It was horrible. By about the 5th month in I had weight gain and started to loose my hair. I was sad and depressed and went off the medication at the 7th month. It was a horrible experience, made me sad and depressed and It didnt help with my migraines at all.

  • BethFebruary 23, 2020 at 1:33 am

    I’ve been on Aimvoig for a year and thankfully no side effects and it has reduced my migraines a lot! I still have them but I get some relief.

  • JuliaFebruary 23, 2020 at 1:14 am

    I had flu like symptoms on Aimovig I was so sick it felt like I was dying, it did nothing for me and actually made my migraines worst with migraine symptoms I never had before, like the band around your head, pulling of muscles in my head. I’m still coming off the side effects from over a month now

  • JohnFebruary 22, 2020 at 10:24 pm

    I took Aimovig for 12 months and i just switched to Ajovy due to cost. It has helped me so much. I can say the only side effects might be a little weight gain and slower skin healing. 20 migraines a month down to 2 or 3. Fantastic.

  • TraceyFebruary 22, 2020 at 9:32 pm

    I love emagility shot it has changed my life

  • DanielleFebruary 22, 2020 at 9:07 pm

    Aimovig has been life changing, in a great way! I’ve suffered from migraines for 31 years and Aimovig has helped me immensely.

  • CarolynFebruary 22, 2020 at 8:49 pm

    I have had hair loss, eye sight is blurry, weight gain, extreme exhaustion, and itching. I have tried both Aimovig and Emgality.

  • KierstyFebruary 22, 2020 at 8:27 pm

    Emgality has helped reduce my migraines a lot. However, I’ve gained at least 15lbs in 4 k months, started to have spasms just below the breast area near upper stomach on left side and now have thoracic neuritis. I’m not sure if I’ll stay on this. Also have worse constipation and fatigued to the point of being bedridden.

  • JenniferFebruary 21, 2020 at 4:30 am

    I started the Ajovy injection in April and by Aug I had lost ALL my hair on my entire body including my eyelashes. I have seen several specialists and am in perfect health and they are telling me it is from this drug. Its February now and I still have no hair growth. Help!

  • NicoleFebruary 14, 2020 at 4:24 am

    I started Aimovig around August and I've had muscles cramps and a muscle rupture in my left arm. Aimovig is the only medicine I was taking.

  • NancyFebruary 11, 2020 at 9:53 pm

    My daughter who is 28 years old had several side effects. She was on Aimovig for 9 months, the last 2 months she doubled her dose to 140mg. She experienced hair loss (she has lost over half of her hair and continues to lose hair, starting to slow down a little), Tachycardia with benign PVC's, GI issues- (severe abdominal pain, did Pill Cam study and her small intestine was full of lesions, biopsie[Show More]My daughter who is 28 years old had several side effects. She was on Aimovig for 9 months, the last 2 months she doubled her dose to 140mg. She experienced hair loss (she has lost over half of her hair and continues to lose hair, starting to slow down a little), Tachycardia with benign PVC's, GI issues- (severe abdominal pain, did Pill Cam study and her small intestine was full of lesions, biopsies for Crohn's disease were negative, stomach ulcers), Facial rash with acne, night sweats, Brain fog, severe fatigue, can't find her words, poor concentration. She had an exploratory lap and again lesions and biopsies negative for endometriosis. Some of the symptoms have started improving, but some are not. The dates she took it July 2018 - April 2019. We would have never connected the dots but she happened to see the Facebook group for Negative CGRP. She has been unable to work for almost 2 years. And no it did not help her migraines.

  • MikeJanuary 22, 2020 at 8:51 pm

    I have a friend who got a double does of Emgality in Feb of 2019 and still suffering the side effects: tinnitus, neuropathy, tingling and numbness and revolving pain through out her body, fatigue, internal tremors, issues with memory. Does anyone know if these effects will ever go away? Is anyone aware of a doctor who is able to treat this? Are their any lawyers working on a lawsuit for this? Than[Show More]I have a friend who got a double does of Emgality in Feb of 2019 and still suffering the side effects: tinnitus, neuropathy, tingling and numbness and revolving pain through out her body, fatigue, internal tremors, issues with memory. Does anyone know if these effects will ever go away? Is anyone aware of a doctor who is able to treat this? Are their any lawyers working on a lawsuit for this? Thank you

  • LauraDecember 11, 2019 at 8:18 pm

    I took one dose of Aimovig and one dose of Emgality. I took Aimovig in July 2019 and it gave me severe constipation that nothing could cure, so I switched to Emgality in August. I have not taken either since because I developed so many scary health concerns: Full body neuropathy (electric shocks, tingling, stabbing, burning, slicing pain), what feels like several types of trapped nerve neuropath[Show More]I took one dose of Aimovig and one dose of Emgality. I took Aimovig in July 2019 and it gave me severe constipation that nothing could cure, so I switched to Emgality in August. I have not taken either since because I developed so many scary health concerns: Full body neuropathy (electric shocks, tingling, stabbing, burning, slicing pain), what feels like several types of trapped nerve neuropathies (cubital/carpal/tarsal tunnel, thoracic outlet, and meralgia paresthetica), my right leg will go numb for days at a time, my hands go numb, facial and tongue numbing, tongue/hand/leg tremors, muscle fasiculations all over body, severe body aches like the flu, constipation, bloating, acid reflux, extreme fatigue, memory problems, making strange mistakes, searching for words, trouble breathing that led me to being prescribed a daily inhaler, tinnitus, heart palpitations and blood pressure spikes (both high and low), severe musculoskeletal pain (especially in the back, legs, and feet). Since taking these drugs, I’ve had MRIs, Xrays, an EMG, tons of blood work, and seen many different types of specialists just to try to find a cause for these issues, and no diseases have been found yet. I have kept track of how my symptoms have progressed, and everything started after I began Aimovig.

  • KristiNovember 10, 2019 at 7:31 pm

    I gave myself my Emgality injection on 10/18/19. Within 5 minutes after my leg swelled up with a huge rash and I wasn’t able to put any weight on my leg. The rash stayed there for 2 weeks. Exactly one week after giving the injection on 10/24/19, I suddenly started feeling very dizzy, had severe vertigo and the room started spinning. My blood pressure sky rocketed and I was having trouble breathi[Show More]I gave myself my Emgality injection on 10/18/19. Within 5 minutes after my leg swelled up with a huge rash and I wasn’t able to put any weight on my leg. The rash stayed there for 2 weeks. Exactly one week after giving the injection on 10/24/19, I suddenly started feeling very dizzy, had severe vertigo and the room started spinning. My blood pressure sky rocketed and I was having trouble breathing. Since 10/24/19, I have severe muscle pain, extreme exhaustion, palpitation, joint swelling and pain, diarrhea, numbness and tingling, double vision and blurry eye sight, pain through out my body, and daily headaches. I haven’t been able to work since 10/24 due to all of these symptoms. The rash is still on my leg as of today 11/10/19.

  • AmberNovember 8, 2019 at 4:30 pm

    I was given the Emgality shot on October 23,2019. Since November 3,2019 I have had severe adverse reactions including anaphylactic. I've had to have 3 epinephrine shots among high doses of steroids. And have been in and out of the hospital since November 3, 2019 and counting. I am now sent home with 2 epipens, high doses of prednisone and needed to take benedryl which doesnt work anyways so I wil[Show More]I was given the Emgality shot on October 23,2019. Since November 3,2019 I have had severe adverse reactions including anaphylactic. I've had to have 3 epinephrine shots among high doses of steroids. And have been in and out of the hospital since November 3, 2019 and counting. I am now sent home with 2 epipens, high doses of prednisone and needed to take benedryl which doesnt work anyways so I will need to continue to go back to the hospital until this is out of my system. Everyday I swell up and break out in hives and I have alot of tightness in my throat to the point it's hard to swallow. This has taken time away from my children. I am unable to do daily outdoor activities due to worsening with sun exposure. I cant believe they would approve something that can cause these symptoms with no reversal to the side effects. This drug should be taken off the shelf. EMGALITY does not help with migraines either it only makes them worse.p

  • KathleenOctober 11, 2019 at 7:57 pm

    Aimovig almost ruined my life. Muscle pain, tremors, shock like jerking movements, fatigue, anxiety, could not walk normally, bedridden practically for six months! Ended up with hospitalization and lumbar puncture, MRIs, EMGs, thought I was dying. No migraine replaced with this? Oh, and rash! Thanks Aimovig!

  • JerriOctober 5, 2019 at 6:48 pm

    I have a list of side effects from Aimovig that are seriously impairing my life. I have found many forums with others also having some of the same side effects. Here is my list migraines, severe vertigo and room spinning, can’t breath, muscle jerks, extreme exhaustion, tremors, palpitation, joint swelling and pain, severe constipation, numbness and tingling, blood sugar issues, insomnia, double vi[Show More]I have a list of side effects from Aimovig that are seriously impairing my life. I have found many forums with others also having some of the same side effects. Here is my list migraines, severe vertigo and room spinning, can’t breath, muscle jerks, extreme exhaustion, tremors, palpitation, joint swelling and pain, severe constipation, numbness and tingling, blood sugar issues, insomnia, double vision and blurry eye sight, kidney and liver pain, severe nausea and vomiting.

  • LoriSeptember 22, 2019 at 10:55 pm

    Aimovig caused heart pain, squeezing, and I have had a hard time, migraines have increased, even months after this horrific migraine medication

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