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FDA Panel Urges Ban on Two Asthma Drugs; Two Others Spared
December 11, 2008 4:39 PM
ABC News' Brian Hartman Reports: A panel of outside advisers has told the FDA that two long-acting asthma drugs -- Serevent and Foradil -- should be banned for use in asthma treatment because they are alleged to be more dangerous than they are helpful, particularly in children and adolescents. If the FDA takes this advice, it would remove the indication for asthma from the label for these drugs but they could still be prescribed for chronic obstructive pulmonary disease.
But the advisers unanimously supported the continued use of the far more popular drugs Advair and Symbicort. Advisers overwhelmingly agreed these drugs provided great benefits to patients, though they expressed some concern about lack of information about how safe they are for adolescents and children.
Here's the panel's vote on GlaxoSmithKline's Advair, the top-selling drug of the four:
Do benefits of Advair outweigh risks in adults? (age 18 and older)
-- 27 Yes (including Dr. Sidney Wolfe, of the consumer group Public Citizen, noting that he voted in the affirmative "with enormous hesitation")
-- 0 No
In adolescents? (age 12-17)
-- 23 Yes
-- 3 No (Wolfe; Julie Zito of the University of Maryland, Baltimore School of Pharmacy; and Dr. Geoffrey Rosenthal, a pediatric cardiologist at the Cleveland Clinic)
-- 1 Abstain (Deborah Shatin, director of Research Programs at the Center for Health Care Policy and Evaluation)
In children? (4-11)
-- 13 Yes
-- 11 No
-- 3 Abstain
December 11, 2008 | Permalink | User Comments (32)
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is albuterol inhaler ok to use my son uses it i am not sure what other ingrediants are in that particular drug.
Posted by: debbie gonzalez | Dec 11, 2008 6:46:28 PM
I was on Advair 100/50 for many years and in 2006 I had a major heart attack. Could Advair be part of the cause?
Posted by: Ronni Herrick | Dec 11, 2008 6:49:47 PM
Our youngest has mild asthma, and was fine using a nebulizer twice a day (when young) and an inhaler once a day and as needed as he got older. His doctor recommended Singular, which I vehemently opposed but my wife wanted since it was supposedly easier. Within two months he was hospitalized with pneumonia for a week. The doctor scoffed at me and essentially laughed when I suggested a link, yet pneumonia is a listed possible side-effect of Singular. I have found many more people online who have reported the same thing. Do not believe what you are told, and get a second, third and fourth opinion, and then do your own research.
Posted by: CSD | Dec 11, 2008 7:05:16 PM
Forgot to add that he had no problems before, and we have had NO respiratory infections since we stopped the Singulair.
Posted by: CSD | Dec 11, 2008 7:06:39 PM
I have been using Advair 100/50 for about three years. I can honestly say it has completely changed my life. I have had asthma long enough to remember the days when there was almost NOTHING to treat symptoms, other than to completely avoid possible triggers. Up until I went on the Advair, I would burn thru a rescue inhaler in two weeks - I tried Singulair and it did absolutely nothing. Up until I started taking Advair, I would have at least one, usually two pretty severe bouts with bronchitis each year and I can honestly say I've barely had a chest cold since taking it. I was extremely concerned about the outcome of this inquiry and am greatly relieved to hear they aren't recommending the ban on this vital (for me) medication.
Posted by: Lori | Dec 11, 2008 7:53:09 PM
Debbie -
If the albuterol was prescribed by a doctor, and it isn't being used outside the parameters of recommendation (I believe most are no more than 2 puffs, 4 times a day), it is fine. From my experience, if he is using it more, it may be losing it's effectiveness. (I used ventolin for about 10 years, and eventually built up a tolerance - I had to switch to a different inhaler, and have since been able to go back to the Ventolin/ProAir style inhaler.) It's been on the market for at least 27 years, as that's how long I've been toting one around.
Posted by: Lori | Dec 11, 2008 7:58:26 PM
I have severe asthma and two of the medicine the FDA wants to ban is on the list. I am asking that anyone that has or has known someone with a lung disorder please contact the FDA and let them know that all Americans with any disorder or disease be allowed to continue living life best they can with the current medicines available and not to ban them. Banning even one of the medicines I take can reduce my daily life by as much as 50%
Posted by: Sierra Night Tide | Dec 11, 2008 8:01:33 PM
I have severe asthma and two of the medicine the FDA wants to ban is on the list. I am asking that anyone that has or has known someone with a lung disorder please contact the FDA and let them know that all Americans with any disorder or disease be allowed to continue living life best they can with the current medicines available and not to ban them. Banning even one of the medicines I take can reduce my daily life by as much as 50%
Posted by: Sierra Night Tide | Dec 11, 2008 8:01:34 PM
for every1 who is wondering albuterol is fine and yes advair puts u at an insanely high risk for heart attack
Posted by: ashma_sucks | Dec 11, 2008 8:18:07 PM
btw for all the ppl using albuterol if u od its usually ok BUT check the subjects reactivity to light, if there pupils become smaller when a light is shown in there face, if they dont or dont get bigger when u take the light away call 991 immediately because thats usually the beginning of a serious side affect of oding
Posted by: ashma_sucks | Dec 11, 2008 8:25:27 PM
I was diagnosed w/asthma in 1985. I've used so many different medicines along the way, and have had a lot of adverse reactions to them. It is common that most of the medicine and/or inhalers cause upper respiratory infections. Singular and Advair are the worst. I've been through it all. You need to have a great rapport w/your doctor so that when you complain about your symptoms they will listen to you and change your medicine. The best inhaler I have used is Proventil HFA. The regular Proventil and especiallly generic brands burn my throat and cause me to cough even more. Coincidence, I don't think so. Generics are not exactly the same - don't believe it!
Posted by: 1w/asthma | Dec 11, 2008 8:52:35 PM
My husband is now on heart medicine for an abnormal rhythm that put him in the hospital for a week after an asthma attack and use of his prescribed albuterol inhaler caused the problem. It is considered a permanent problem now, and it has really degraded his health. He takes xopenex now.
Posted by: Maple Fan | Dec 11, 2008 9:01:25 PM
Forgot to post in my original message...
Using a "spacer" is an excellent way for people to get the maximum benefit of their inhalers. I've been using the "Aero Chamber" for over 15 years. That way your medicine just doesn't hit the back of your throat - it gets deeper into your lungs.
Posted by: 1w/asthma | Dec 11, 2008 9:03:04 PM
Advair nearly killed me!!! After I started using it I got a horrid upper respritory infection. My asthma was fine but I coughed until I thought my lungs were gonna come out! When I went to the Dr. he had the nerve, because I sounded so bad,to ask me if I was a smoker!!!! NOT! NEVER!!! He was no help so did research myself and found on the Advair web site that one of the complications is upper respritory problems. Quit immediately and started feeling better too and after three days was me again after weeks of suffering! I had asked my Dr. if he thought it was the Advair before I went on the Advair site and he said NO!!! WOW and SOS!!!!
Posted by: Asthmatic | Dec 11, 2008 9:04:46 PM
I have been trying to get off Serevent for years...finally succeeded by ***slowly*** weaning myself off. It took FIVE years to discontinue this drug. Many times when I tried, it felt like an elephant was on my chest. I've been totally off the drug for about 5 months and doing much better *without* it! It's a scary drug, however, please DO NOT abruptly stop taking it as that may kill you. Sad that the FDA is getting rid of in the inhalers & replacing with the more potent, heavy duty powder which is all the worse. And thank you to all those working for asthma cures, relief, etc. Naturally, it's trial and error.
Posted by: Rosemary | Dec 11, 2008 9:27:02 PM
My 8 yr old was on Advair and had severe side effects, Doctors didnt want to believe me that it was the Advair. Luckily, I was able to politely prove them wrong. She is now on Symbicort and its not working as well but I am concerned with not knowing how it REALLY may affect her long term
Posted by: Therese Botell | Dec 11, 2008 10:11:24 PM
I'm 40yrs old,have had asthma since the age of 6. Almost died from a bad attack when I was 18. Started Serevent in 1996 then eventually switched to Advair. This medicine gave me a life. Otherwise, if not on this medication, I'm doing nebulizer treatments 4x daily,lugging around this machine everywhere I go. Not to mention the fast heart beat side effect from it. Since 1996, I have had to use my recue meds only a few times a year! Not 4x daily like I did. I think people need to understand that (My doctor says it) You will still need your emergency meds (xopenex inhaler etc.)if you have an attack. It is also important to be on some form of inhaled cortisone while taking Serevent to treat any inflamation. People need to remember that Serevent/Advair is not for instant relief of an attack,it is more of a preventative. Sadly there have been deaths, but I think it's because they lacked the appropriate rescue medication at the time of attack, not because they were taking serevent/advair. People have died from asthma long before this medication even came out. These meds might not work for everyone but for me, I owe my life to it.
Posted by: kristen | Dec 11, 2008 11:19:14 PM
I hope all of you read this. Go to www.asthmastory.com and read about treating asthma with Zithromax .... 600 mg. taken three days in a row and then once weekly for 12 weeks and then possibly do another round of treatment. This works! Dr. David Hahn of Wisconsin is conducting studies all over the country now with this treatment. Go to the website and read the story and go to the links telling about this research. My son has had moderate asthma for 10 years and has been on this Zithromax therapy, two round now, and is so much better - he is off all asthma medication. No more Pulmicort, and Serevent is very dangerous, and so is Singular - my son was sick from being on Singular just liek the story above. This medicine is terrible and it all just masks the symptoms of asthma. Please go to this website and share this with everyone you know. We are hoping our son is cured of asthma - asthma is an infection not a disease!
Posted by: Sherri | Dec 11, 2008 11:45:45 PM
Do not use albuterol ...use hot water with salt and you will see how your children will get better ...
Posted by: Luis | Dec 12, 2008 12:05:59 AM
Reading through all of the comments on this issue plus the FDA study leaves one to wonder if any asthma drug is safe. On the other hand, what choice do you have? You either take the drug prescribed with its attendant risks, or you don't take anything and in short order repair to or are taken to the nearest hospital. Some choice!
Posted by: John Locke | Dec 12, 2008 1:02:15 AM
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