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

  • Written by: Irvin Jackson

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.

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.”

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  1. Lori Reply

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

  2. Jerri Reply

    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.

  3. Kathleen Reply

    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!

  4. Amber Reply

    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

  5. Kristi Reply

    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.

  6. Laura Reply

    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.

  7. Mike Reply

    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

  8. Nancy Reply

    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.

  9. Nicole Reply

    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.

  10. Jennifer Reply

    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!

  11. Kiersty Reply

    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.

  12. Carolyn Reply

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

  13. Danielle Reply

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

  14. Tracey Reply

    I love emagility shot it has changed my life

  15. John Reply

    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.

  16. Julia Reply

    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

  17. Beth Reply

    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.

  18. Erin Reply

    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.

  19. Michelle Reply

    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.

  20. Katalin Reply

    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?

  21. Marcel Reply

    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.

  22. Jennifer Reply

    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

  23. ROS Reply

    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.

  24. Julianne Reply

    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.

  25. Lise Reply

    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.

  26. Natalie Reply

    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.

  27. Brenda Reply

    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!!

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