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Risks of Advair and other asthma drugs used among children to be reviewed by FDA

Austin Kirk

An FDA advisory panel will meet this week to review the asthma drugs, Advair, Serevent and Foradil, to examine whether the medications are safe for use among children.  Side effects of the drugs could cause serious problems, including death, and the risks may outweigh the benefits for children.

Asthma affects about 6.5 million children in the United States.  The chronic disease causes a narrowing of the airway, which is associated with wheezing and difficulty breathing.  Advair, Serevent and Foradil are long-acting beta agonists, approved for the long-term prevention of asthma among those 12 years and older, whose asthma is not controlled by corticosteriods.

Serevent contains the active ingredient salmeterol, and Advair is a combo drug, containing salmeterol and a steriod.  According to studies, salmeterol causes a four times increase in the risk of asthma-related deaths.  Foradil, containing the active ingredient formoterol, could increase the risk of asthma exacerbations and hospitalizations.  All three drugs currently contain a “black box” warning indicating that they may increase the risk of asthma-related death, but the advisory panel will evaluate whether the drugs are safe for use with children at all.

An FDA pediatric advisory committee is scheduled to meet this week, and will review the safety of Serevent, Advair and Foradil, as well as several other drugs used by children.  An FDA staff memo released in advance of the hearings, indicates that Foradil, Serevent and Advair side effects may carry more risks than benefits when used for treatment of asthma for children, and recommends a more thorough analysis be conducted.

The FDA conducted a review of reported adverse safety events associated with the drugs.  During the 13 month period between March 2006 and April 2007, 9 problems were reported among children using Serevent, including five deaths.  Between 1994 and 2007, 23 pediatric deaths were associated with Serevent.  Between 1999 and 2007, 15 pediatric deaths were associated with use of Advair.

Serevent and Advair are manufactured by GlaxoSmithKline.  They are the best selling drugs made by the pharmaceutical giant, generating $6.13 billion in sales last year.  Glaxo has recently suffered significant financial setbacks after their diabetes drug Avandia was linked to an increased risk of heart attacks, and they face thousands of Avandia lawsuits from users who have suffered injuries.


The lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for Advair, Foradil and Serevent side effects which resulted in death for the user.  If your friend or loved one died as a result of one of these asthma medications, request a free consultation and claim evaluation.

12 Comments Add Your Comments

  1. hi, oh my!
    not goo dmy son has been on the advair 250 flat round inhaler about 8 mnths ahhh shoul di b taking him off of it?

  2. By “pediatric” deaths what age are you talking about? My child is 16 and has been using Advair 250 for 3 years and has not experienced any problems. When you say pediatric are you talking about children under the age of 10 or over 10? Do I need to be concerned?

    The information came to me thru my insurance carrier.

    Thank you.

  3. My son is on Advair. Please keep me informed on the FDA review. This is very disturbing information. Should I be taking him off Advair.

  4. Austin Kirk says:

    Any concerns about whether your child should continue using Advair should be reviewed with your physician. Certainly no medication, especially one used for long-term prevention of asthma, should be discontinued without the supervision of a physician. We will update our site with any new information about the FDA review of these asthma drugs.

  5. My son was diagnosed with asthma about 1 1/2 years ago. He was first on albuterol and pulmicort then was sent to an asthma specialist in Fort Worth , Texas and is now taking Advair 115/21. I noticed even on the first night of treatment he was very nervous, jittery and anxious like he couldnt sit still for one second, he was having very bad night sweats and at first he was having tremors in just his arms, now his whole body tremors at night and his eyes are glassy all the time. He stays irritable all the time now and sometimes I can not get him to sleep at all . Other nights he is so weak and tired I cannot get him out of bed in the mornings for school. I even called the doctor the second day he was on the Advair and the doctor assured me ths medicine was safe and that the studies conducted on Advair were horrible conducted and that the side effects were very little . He also told me the tremors were from the prednizone my son was taking at the time . MY son has been taking the Advair for one month now and the symptoms are still there. It is February 14, 2008 and as my son was sleeping his whole body shook uncontrollably . I almost took him to the emergency roon tonight but bout 4 minutes the tremors quit . A little later he had more shakes in his hands and his his legs but not as bad. My sons pillow was soaked from a fever he has been running every night for five days as I think is due to the medicine. I am including a link to a site where I found others like me who had either suffered symptoms or hda family member who had experienced the very bad side effects of Advair. If there is any way for all of these people including me to come together and sue the makers of Advair please let me know . I had asked my doctor to take my son off of it and he said it was not wise since it was controlling his asthma . How can a medicine be considered safe if it causes the person to succumb to such side effects that may be deadly ? :PLease help me and others who are in need of medication to control our loved ones asthma symptoms. My son is only four and I would hate to lose him cause of the doctors and the FDAa stupidity in approving a drug that has caused so many people so much pain and the symptoms are not just in our imagination as some think . The symptoms are real and in my opinion from observing my son they can be very life threatening and possibly deadly ?http://www.medications.com/se/advair-hfa

  6. Eric Roberts says:

    How nice that you haven’t updated your website with the FDA review. I checked with my Dr. b/c my son is on Advair. I also checked the FDA’s website. Advair still is approved for children.

  7. Austin Kirk says:

    Mr. Roberts,

    Thank you for your comments. A follow up post was placedn the site days after the hearing about the decision to add warnings to the medications. At this time, the FDA is still reviewing these risks, and plans another advisory panel meeting in fall/winter 2008.

    Here is the current information from the FDA Website:

    March 5, 2008 Update: On November 28, 2007, a Pediatric Advisory Committee (PAC) meeting was held. At this meeting, FDA raised concerns about the safety of long-acting beta2 adrenergic agonists (LABAs) in pediatric patients with asthma. The PAC has agreed with an FDA recommendation to continue assessment of the risks of LABAs and seek advice from a future advisory committee (http://www.fda.gov/ohrms/dockets/ac/oc07.htm#pac).

    In January, 2008 FDA requested manufacturers of Advair Diskus, Advair HFA, Brovana Inhalation Solution, Foradil Aerolizer, Perforomist Inhalation Solution, Serevent Diskus, and Symbicort Inhalation Aerosol to provide information regarding controlled clinical studies conducted with these products in order to further evaluate the safety of LABAs when treating asthma.

    The manufacturers have indicated it will take several months to submit the requested information. Following review of this information, FDA plans to bring the issue of the benefit/risk assessment of LABAs in adults and children to an advisory committee in the fall or winter of 2008.

  8. Okay, Fall/Winter of 2008 has come and gone. What is the update on the use of Advair in Children? My son is now 13 and has been on Advair since Jan ’03 (age 7) with a dose of 500/50, it was later lowered to 250/50 and now 100/50. I believe this has effected his growth rate, although his doctors insist this has not. They are only looking at the past 6 years- well he has been on Advair for 6 years. Of course they put the scare in me by saying that if I take him off Advair this could be more harmful and Advair is keeping him healthy. This also means bloody noses and just recently irregular heartbeat and gastrointestinal discomfort/pain (this just recently kept him home from school). Initially another treatment was not offered, so I took the one to ‘keep him healthy and active’.

  9. My son has been on Advair since he was 7. The ped clinic started him out for years on the 500 and then put him on 250 and just last year put him on 100. His growth is not that of a normal 13 year old and his heart races. His mother is now concerned that he may have irrepairable damage from the medication. If pediatricians know of the problems, why do the still push the medication on young children.

  10. I have been on advair for about 4 years. I usually take advair 500 in the winter. And advair 100 in the summer but the doctors tried to take me off it but about two days later I could barely walk to the car from my house so they put me back on it. Now I get itchy out of no where abd get extremely hot like i can go outside with no coat and shorts on in 17 degree weather (i can be outside for like 30 minutes before i get cold)and most doctors I’ve been to they say it from having anxiety attacks and I’m only 14.. So I don’t know if this is all from advair but I would recomened going on any other asthma medicine then advair.

  11. To all concerned re: Adair, Symbicort, Serevent. Please be advised that most of the reported problems with these drugs are linked to use of a Long- Acting Beta- Agonist ( Salmeterol, Formoterol ). The major benefit derived from these type of drugs is control of airway inflamation provided by the cortico-steroid, fluticasone propionate for Advair, budesonide for Symbicort. My advice is to ask your doctor for a trial of inhaled cortico-steroid with-out the LABA ( but have available a SABA such as Albuterol for sudden onset of symptoms). Some other products that only contain cortico-steroids are: Qvar (beclomethasone), Pulmicort (budesonide), Alvesco ( ciclesonide), Aerobid ( flunisolide), Flovent (fluticasone), Asmanex (mometasone) and Asmanex ( triamcinolone). Remember, all medications have side effects. The goal of Asthma Control is to have no or fewer asthma episodes of lesser severity/ duration and with no or minimal side effects. Hope this helps.

  12. my 5 1/2 year old son been taking Advair HFA 45/21 mcg(120puffs) 12gm for about 5 to 6 months and im concerned by reading these commnts about children are not suppose to be taking this medication. He has really bad asthma and allergies and i was also concerned about the strength that the dr. gave him. my son has other problems and i hope its not this medication affecting his health. Concerned mom.

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