Asthma Inhalers Foradil, Serevent, Symbicort and Advair Increase Risk of Death: FDA Officials Warn
Published: December 9th, 2008 • Comments: 23
Several FDA officials have warned that because side effects of Advair, Serevent, Foradil and Symbicort may increase the risk of death, an FDA advisory panel should recommend that approval to use the drugs for treatment of asthma should be withdrawn or severely limited.
These medications are known as long-acting beta agonists (LABAs), and they are commonly prescribed to help avoid the inflammation of airways in the lungs and prevent asthma attacks. While they have been found to keep airways open, use of the medications could potentially increase the severity of future attacks, especially among children.
A panel of independent advisors to the FDA is scheduled to meet this week to review safety data on the four asthma inhalers.
In advance of these meetings, two FDA officials have concluded that asthma patients of all ages should no longer use Advair, Symbicort, Serevent or Foradil due to the increased risk of death. A third FDA official has indicated that Advair and Symbicort could still be used by adults, but that none of the inhalers should be used by children 17-years-old or younger.
Asthma is a chronic disease which affects 20 million Americans, including 6.5 million children, causing symptoms like difficulty breathing, spasms and wheezing.
Unlike rescue inhalers, which contain the beta-agonist albuterol and have a limited duration, these long-acting beta agonists are designed to be taken daily to prevent asthma attacks.
Advair, which is the biggest seller out of the four asthma drugs, is manufactured by GlaxoSmithKline PLC and generates sales of nearly $7 billion annually. The inhaler combines a steroid with Serevent, which is also made by Glaxo and contains salmeterol as its active ingredient. Sales of Serevent alone were $538 million last year.
Foradil, which contains formoterol as its active ingredient, is manufactured by Novartis AG and marketed in the U.S. by Schering-Plough Corp. It is used in combination with an inhaled steroid is Symbicort, which was introduced by AstraZeneca last year. In the first 9 months of 2008, Symbicort generated sales of just over $200 million.
The drugs already contain “black box” warnings about an increased risk of hospitalizations and death from asthma attacks while on the drugs, which is the strongest warning that can be placed on a prescription medication.
The FDA advisory panel is scheduled to meet on December 10 and 11 to consider whether additional regulatory actions involving use of these inhaled drugs to treat asthma should be recommended.
Even if approval for treatment of asthma is withdrawn, a recall of Advair, Serevent, Fordail or Symbicort will not occur, as the drugs are also approved for use in treating individuals suffering from chronic obstructive pulmonary disease, who are usually elderly.
Comment by Lisa on 10 December 2008:
My 14 year old daughter’s dr had her on every asthma medicine out there over a span of 6 years advair and symbacort. When i told her i had quit giving them to her due to them making her breathing much worse she told me to continue giving them to her because that was impossible so i did. Then when the effects were the same she finally had her tested for asthma and she didnt have asthma and now she may have heart problems. Her dr refused to refer her to pulmonologist to have her heart checked. My daughter is still having pains in her chest and her dr has now told us “call another dr”.
Comment by gaetano on 11 December 2008:
now have a fast and irregular heartbeat i belive i got from using foradil aerolizer
Comment by Kristin on 11 December 2008:
Removal of medications that make daily living easier for thousands, even millions of people is irresponsible and dangerous. All medications have side effects. Whether they are synthetic or natural, nothing is “safe”. For those who have finally been able to manage symptoms that have made usual activities difficult, the risks may far outweigh the benefits. I speak from experience. I had childhood asthma that disappeared in my late teens and early 20s. At age 26, it came back. I have been on multiple medications and have found that Symbicort is the best thing for me so far. I can breathe and don’t have episodes of breathlessness that require use of a rescue inhaler. Perhaps the FDA needs to contact some of the users of the medications they want to recall and get their opinions. After all what were human trials for? No one knows long term effects, but we live in a world where anything is a potential killer. I say I’ll take my chances with the inhalers!
Comment by Agnes on 12 December 2008:
I have been on Advair for four years. It has helped keep my asthma under control, but within the last two years, I have been experiencing heart palpitations. I wonder could this be the beginning of a possible heart condition
Comment by Carol on 12 December 2008:
My current doctor help invent Advair. He is also pushing Xolair as well. He was part of the team that had invented and clinical tested it. I am not sure about the Xolair. I take advair now along with several other asthma/allergy medications. The list is ridiculous.
Pingback by FDA Panel Indicates Foradil and Serevent Should Not Be Used for Asthma : AboutLawsuits.com on 12 December 2008:
[...] to the FDA advisory panel meeting, several agency officials suggested that the use of long-acting beta agonists, either with or without the inhaled steroids, should be limited. Two FDA officials concluded that none of the drugs should be given to asthma patients of any age, [...]
Comment by Jackie on 12 December 2008:
I had a call from a neighbor saying the Symbicort was being pulled. I paniced because it has given me back freedom. I use Symbicort twice a day and Zyflo tablets twice a day. A great combination for me. Glad to hear the recall is tied more to individuals under the age of 18. Glad to be 48!!!!
Comment by KATHLEEN on 14 December 2008:
I just called my pharmacist to make sure that my childrens asthma medications are not part of the recall and i was told that nothing was taken off the market at all. Why did the pharmacist not know about the medications listed in the above email? Our pharmacist was not helpful at all and i have two children that are on singular, proair and xopenex and i am assuming that those arent one of the medications on the list, at least i hope so. The pharmacist said he could not help me anymore. I am a concerned parent and i hope that my xopenex and proair inhalers my children use are not affected. my son was on symbicort and was taken off the symbicort awhile ago. since then i do not have an allergist because the allergist i was using just dropped my kids and refuses to treat them and every other allergist i call wants their own set of allergy tests and my children already had allergy tests done several months ago, so it is impossible to even find a new allergist until my insurance will pay for new allergy tests. if something gets recalled unless i have the news on or see it in the paper i would not have a clue what is recalled. if you have any information about singular chewables and the proair and xopenenx i want to verify that they are safe. i had some reservations about singular given at night bevcause of the side effects so i give to my two children in the morning. If i have a concern it is my right to have it addressed but our pharmacist was not able to answer our questions.
Comment by Allison on 14 December 2008:
I was diagnosed with asthma when i was 13. Foradil was the first medication that I was prescribed to help prevent attacks. When the foridil was no longer enough to hold off attacks I was prescribed to take Pulmicort with it.
I took both meds daily for about 4 years. Without it, I never would have been able to be a part of the track team. My first year of college, I switched over to advair. After being on advair for about 2 months, i experienced a few of the minor symptoms, and I was using my rescue inhaler a lot more.
My doctor switched me to Symbicort, and I have been using it throughout my sophomore and junior year at school. I still run track, and I am so happy that Symbicort gives me the freedom i need to do what i want.
Comment by Steve on 21 December 2008:
I wonder how many of these comments are made by employees of the mentioned drug companies. My doc just prescribed Symbicort to me and now I’m hesitant to take it.
Comment by james on 4 January 2009:
im taking advair and symbicort for over two years . my eye sight and breathing has gotting worse. now what do i do?
Comment by Gary on 10 January 2009:
Age 34. I have had Asthma since I was a kid. Done allergy shots along with everything else. Stopped the shots because they made me sick. Only had major problems in the summer time. Also had the problem of dyshydrotic (small blisters that form on the hands and feet that itch and burn) so bad it was difficult to even work. Hands always looked like bloody, skin pealing, oozing yeck. All doctors would do was put me on prednisone (went to several doctors for opinions). Last doctor put me on Symbacort for my asthma for short turm use and guess what? My hands cleared up and I do not have problems with my asthma or hands. I am sure it does harm. Sure beats the stress and the thoughts of suicide because you loose your mind to your illness. Who knows how long we are to live. No one has ever missed there appointment with death. We take a chance with everything we do. I have heard of peaple dying from peanut butter, after eating from a resturant, car wreck, drinking and smoking. You coulld even have complications after the good ole common flu shot! These are common every day things to most peaple. Why not at least be able to enjoy life to begin with, Anything effects everyone differently.
Comment by Joanna on 14 April 2009:
I have a 6 yr old daughter who has had breathing problems and been on a nebulizer since she was 7 weeks old. She has has severe allergeries that trigger her asthma. She has been on Xopenex, Foriadil, and recently was placed on Symbicort by a childrens hospital and respitory specialist. However, everything I read says 12 and under should not be on this medication. Even with 3 daily doses of allergy medications and two doses of Symbicort a day she still has to use her rescue inhaler occasionally. I am worried that I might need to take her off this medicine. Does anyone else have a child my age taking Symbicort?
Comment by Sharia B on 15 April 2009:
I had asthma since 1999. I was placed on different asthma meds, such as Advair, Symbicort and predisone whenever I has an attack. While on Advair, I was placed on 250 and 500 doses, some improvement in asthma attacks. Then, my med was change to Symbicort an year ago. My attack has decrease. Proper asthma manament and staying inform about my asthma and meds which is needed to maintain a great life is require.
I will discuss this new infomation with my Dr in the future.
Comment by Diane on 2 May 2009:
I have been on foradil for years. I recently was diagnosed with glaucoma and small cataracts. In just a few months the cataracts grew at an unusually quick rate. My glaucoma is not under control. I am losing my sight.
Comment by Tom on 15 June 2009:
I have been taking Advair for 5 years. I have just been diagnosed with severe glaucoma and catarats which will require immediate surgery. My eye doctor said it is absolutely caused by the Advair and could have been prevented. He was angry that my previous eye doctor never discovered the probem. I am suing the makers of Advair.
Comment by ALISA on 11 October 2009:
I WAS PUT ON ADVAIR FEW YEARS BACK AND IT GAVE ME CHEST PAINS SO BAD THAT I HAD TO USE A HEATING PAD ON MY CHEST OR GET IN SHOWER LET THE HOTTEST WATER HIT MY BREAST . WAS PUT ON SPIVARA AND IT HAD THE SAME SYMPTOMS WITH ME. AFTER AWHILE I WAS PUT ON SYMBICORT AND AFTER 2 WEEKS USAGE OF IT I STARTED HAVING PANIC ATTACKS AND SLEEPLESS NIGHTS STAYED UP FOR DAYS THAT I HAD TO START TAKING VISTARIL SO I COULD SLEEP AND CALM DOWN FROM THE PANIC ATTACKS, QUIT TAKING IT AND I STOPPED ALL MY SYMPTOMS. PUT ON PULMICORT AND THE SAME THING PANIC ATTACKS AND NO SLEEP, I TOOK PULMICORT FOR AWHILE SO IT HAD TO WEAR OUT OF MY STSTEM, I’M JUST GETTING IT OUT OF MY SYSTEM AND BACK TO MY ALMOST REGULAR SELF , USEING BENADRAL NOW TO CALM DOWN AND CAUSE SLEEP .THANK YOU
Comment by Nielsen on 14 October 2009:
I have adult asthma and allergies which I never experienced in my younger years. I am 43, and this all started when I was about 37.
I have been using Advair to control asthma, but I have chronic sinusitis, which causes freuent infections… big problem for me, I am sa singer! When my sinusitis flares up, I have been using a methylprednisone pack. The pack works better than anything, however, I developed severe cataracts and had surgery in both my eyes this past June. The surgeon believed it was due to the prednisone as opposed to to Advair. Methylprednisone packs are an enormous amount of steroid to be taking. But hell.. it WORKS like you wouldn’t believe, but for me, doesn’t last. I get sinus infections every 3 months, and have t go on it again. Huge amounts of steriod to be taking… now, I have developed the beginnings of vocal nodules, this is a dead end for singers, so, today I was prescribed Sybicourt, to get me off of Advair because it is a powder that contacts the vocal chords, as opposed to a mist like Symbicourt, and might be better for me. I am TERRIFIED to begin taking it, I took my Advair this morning, and he wants me to start Symbicourt tonight.. I’m not going to do it, I am far too afraid… I’ll wait till tomorrow night, and will not take the Advair in the morning. Any suggestions?
Comment by Terry on 23 October 2009:
Symbicort stopped my heart. I was defib’d twice and was in a coma for three days.
Comment by Karen M on 2 November 2009:
I was put on Symbicort a few months ago and WAS thrilled because I was breathing much better with it. However, I almost immediately began having mild panic attacks when I had a trigger event. Wthin 6 weeks I was in full blown major Panic Attacks and had to stop using Symbicort. It took about 5 days to feel normal and I have not had another panic attach since stopping Symbicort. My specialist said he had not heard of such a side effect but put me back on Advair. It doesn’t work as well but at least I’m not waiting to be taken to the looney bin! lol.
Comment by Susan Y on 10 December 2009:
I have been asthmatic since i was 13. A week & a half ago I developed bronchitis. My dr gave me a sample of symbicort. It nearly killed me. Within 10 minutes of using the inhaler I was on my knees gasping, wheezing & calling 911. Very glad to be here. Will NEVER touch that crap again!
Comment by Chris J on 20 February 2010:
I always read the inserts on all drugs, and this one scared me. While I was recovering from a serious infection, my doctor had given me a sample of Symbicort, and gave me a prescription for more. I used all of the sample, but was reluctant to fill the prescription, partly because I didn’t feel much in the way of improvement. He said my fears about the warnings on the insert were unwarranted, so I went ahead and got another inhaler. While some of the inflamatioin went away, I had a nasty taste in my mouth, and no food or drink tasted right. Although I washed my mouth out thoroughly after each use, I felt like something was “growing” down in my throat and airway. I had difficulty breathing. I stopped using the product, and gradually my sense of taste returned. The feeling of something growing and blocking my airway went away. I am wondering if I had thrush in those areas which could not be washed out?
Comment by b on 24 February 2010:
my mother was taking albuteral first..then it was off the market docs prescribe proair which we did’nt like did not work the same??? started taking advair aaround 07 3 times a day for what they THINK was copd… every 2-3 weeks she is in an abulance due to cant breath….why no one put two and two together was beyond me…finally last time she couldn’t breathe EMS couldn’t get into house for over 20min…her braind starved of oxygen . .. she died no brain activity..from what i have read the fda knew about the SMART study between 1996-2004 and shut advair down..too many deaths…if someone would of know about blacked boxed or even if I WAS AWARE OF IT maybe could of prevented my MOTHER’S DEATH in 2009!!!! TOTALLY UNACCEPTABLE