Advair scare
- Get the widow on the set, we need dirty laundry.
- Don Henley
Thursday morning on the Today Show, Katie Couric spoke with Forbes managing editor Dennis Kneale (see the clip here). Kneale was discussing this article in Forbes magazine about the GlaxoSmithkline Asthma drug Advair, and concerns about its safety. The overall question is an important one, worth consideration: what do you do when a drug helps millions, yet can be harmful or fatal to a small percentage. I have a real problem with the way this article, and Kneale's comments on the Today Show, frame the issue.
When I first heard about possible dangers of Advair, I consulted with a friend who is both an MD and asthma sufferer. Advair actually contains two drugs. One is a steroid, the same steroid found in the GlaxoSmithkline's Flovent, which eases inflamation of the airways. The second, a bronchodilator that expands constricted airways, is the same drug found in the GlaxoSmithkline product Serevent. It belongs to a class of drug called beta agonists. All bronchodilators I know of are beta agonists, and some people have adverse reactions to them. The problem with Serevent is that it lasts longer (12 hours instead of 4-6), so an adverse reaction will go on longer before symptoms subside.
The article opens with two stories of people suffering reactions to Advair. One person said that, despite complaints of ill effects, his doctor said to keep taking it (sounds like the doctor's fault to me). The second was another story of someone suffering ill effects who continued to take the drug, an includes visual that is gratuitously repeated throughout the article: dying while still clutching the inhaler.
The the article highlights Advair's popularity, noting the advertising dollars spent. I can't argue with that; I am against prescription drug advertising. I didn't like the way the discussed Advair's "nifty delivery system," which they called a "purple plastic puck." Kneale also uses the purple puck term in the interview, telling Katie how "doctors love gadgets." His tone suggests that it's some kind of unecessay gimmick product, the asthma equivalent of the Swiffer.
In fact, the Advair Diskus (as it's called) is a vastly superior delivery method. Aerosol inhalers required the user to inhale at the moment as the push the cannister down. If you're off (as I was from time to time), you end up spraying most of the drug on the back of your throat instead of inhaling it. Further, unless you kept careful count of uses, you didn't know quite when the inhaler was empty. Finally, you needed between 2 and 4 inhalations, 60 second apart, each time you take it. Advair has a little number that decreases with each use. It turns red when you're under ten doses left. When you inhale, the force of your breath draws out the drug, so you always inhale it properly. Finally, you only need to inhale once each time. That's as much of a gimmick as anti-lock brakes.
Another issue they highlight is overprescribing. One of the people in the openning paragraph also had a persistent cough and wheeze, but was not diagnosed with asthma. Kneale talks about how his doctor prescribed it to him for a persistent cough from bronchitis. He doesn't say if it helped or not. The article also notes that Advair is being prescribed to more than just severe asthma sufferers. I thought that was unfair. My asthma was never severe or life threatenning, but it is still very important to my long term health that it be kept well controlled.
The article and Kneale play free an loose with the numbers. The first statistic the present is a single doctor's assertion that Advair and Serevent are killing 4000-5000 people a year. Only later do the note studies that showed numbers like 12 out of 17000, still taking time to suggest that this finding was inappropriately deemed statistically insignificant. When numbers minimize the risk, the article's tone is always questioning. They never cast doubt on the 4000 deaths/year estimate.
They also mix in statistics for other bronchodilators, like in this paragraph:
But Serevent had been under suspicion from the start, and earlier beta agonists had stirred doubts for decades. In 1948 one study of 2,200 asthma patients found a fivefold-higher death rate for patients who inhaled epinephrine, a beta drug, versus those who hadn't."
First off, I checked and found that almost all bronchodilators are beta-agonists. This article doesn't mention that. Non-beta bronchodilators are not inhaled - they're taking orally, so the side effects tend to be worst. Theophylline is non-beta example I've taken, and it sucked. As for epinephrine, the article is correct about its dangers. I've taken it - it's awful stuff. What the article failes to mention is that more modern beta drugs, Serevent included, are a vast improvement. To read the Forbes article, you'd think epinephrine and Serevent are like Motrin and Advil.
The article does everything it can to hype the danger aspect of Advair. They're searching for the next big drug company scandal.The article says as much when it conjures up the spectre of Merck's Vioxx and Wyeth's Redux. I'm all for keeping the drug companies honest, mind you, but Forbes this article is heavy drama and a light cogent fact. There is next to no mention of the drugs success in controlling asthma and similar respitory ailments. In my opinion, that success is the real reason for Advair's popularity.
There are also no anecdotal stories of people who's lives have improved thanks to Advair. So, here's one:
When doctors, insurance companies, etc. try to assess how well you are managing your asthma, they want to know how often you use your rescue inhaler. A rescue inhaler is a fast acting bronchodilater you use when you're having an attack. If you are using it often, you asthma is not well controlled, and you could be doing harm. Since I began taking Advair, I have all but stopped using my rescue inhaler. If I use it three times a month, it's a lot. I used to use it at least that many times a week. My respitory health has improved drastically thanks to this drug.
I'm one of the millions it's helped. I'd prefer a little less media hype about this one.
19 comments:
Andrew, Read your article and you've done good research. However there are a few things I think you'd like to know.
Regarding this comment: "In fact, the Advair Diskus (as it's called) is a vastly superior delivery method. Aerosol inhalers required the user to inhale at the moment as the push the cannister down. If you're off (as I was from time to time), you end up spraying most of the drug on the back of your throat instead of inhaling it." Actually a study done in Europe showed that Advair is the most often misused product at 25%, then Pulmicort at 17%, an MDI(aerosol inhaler) at 13%, and a MDI with a spacer 3%! Suprising?
Another problem with the Advair deliver system is that those who are currently having problems breathing are not able to "suck" in the medication to their lungs.
Regarding the serevent componant, it's absolutly unnessesary, and is what makes the medication dangerous.
The FDA recently stated that even though Advair reduces the frequecy of attacks, when the attacks happen they are more severe, and sometimes deadly.
There is a good reason for this. Servent eliminates symtoms, but does NOTHING for the swelling of lung tissue. Serevent hides the fact that the disease is out of control. If serevent isn't being used the symtoms tell you to increse the seriod dose to reduce the swelling in the lungs. Since serevent is being used it hides the symtoms until the disease is out of control, and it's too late to increase the steroid. That's how it's killing people. People have severe attacks because they don't know to increase their steriod dose.
What is interesting is that in a head to head study between Advair and Flovent, Advair reduces symtoms better than Flovent up to 12 weeks. From 12-52 they are the same. There are two reasons for this: One After 12 weeks of daily use of Serevent it ability to it's job is cut in half. Tolerence. Two, The steriod is actually what prevents the inflamation in the lung tissue which creates attacks. It takes time for the steriod to ramp up. Weeks. Here's the problem, Glaxo only show's in it's marketing material to Doctors the first 12 weeks of that study.
One last point the SMART trial was ended early because the Advair had patients dieing at a 4 times greater rate than those in the Flovent arm. It never reached statistic significance only because the trial was ended early! The FDA has stated recently that their data in confirming the trial data.
I think the main thing to keep in mind is that there is no benifit to using serevent. Just risk. Patients should use a steriod alone. If they fail, add a luektrine modifier, add servent to make them feel better as a last option. Not a first. Only the most severe of severe should be using it because they have no options.
Sean, thanks for the information. I am definitely surprised by the Europe study, particularly that an MDI without a spacer did better than the diskus. Is there a link to that study? I'm interested in how it was misused.
The issue with people unable to suck in the medication makes sense. Does an MDI work that much better there? I've had attacks where I could barely use my rescue inhaler, where only a nebulizer was effective.
The remaining doses indicator was big for me. I could never keep track of how much was left in the cannister. The single inhalation was also big. If they could solve these issues on an MDI, I'd probably be more open to them.
But getting down to the drug itself, that's very valuable information, and it makes a lot of sense. It certainly raises concrete issues I should consider WRT Advair.
This brings me back to my original complaint about the Forbes article. You're comment contains more useful information than the entire Forbes article.
Consider your explanation of the Serevent component hiding the need for a more steroids until it is too late. This is not even in the article. Instead, they devote a paragraph to a 1948 epinephrine study which is much more dramatic, even if almost entirely irrelevant.
Stuff like that really bugged me. I take Advair, and I'm sure as hell want to know the risks. They had the opportunity to be informative, but chose instead to be dramatic.
Anyway, thanks again for the information. If you have any online references to studies, etc., I'd be grateful.
Andrew, regarding the study done in Europe on compliance, I had a copy somewhere. I'll find it online and copy you to the link. Just off the top of my head, there are a couple of ways people misuse Advair. 1) The exhale into the device before they inhale. That messes things up. 2) I think old people (my grandma) have a hard time figuring it out. To your point, the old and young often can not inhale at the right moment with a MDI. That is why a spacer should always be used.
The dose counter is a HUGE problem. I agree completely with you on that. There is also a problem with a lot of the MDI's in that they continue to propell even after they run out of medication. One good reason to use Provental HFA, for your rescue inhaler. If it puffs, it gives you medication.
I read the article as well, and the problem with the way they wrote it is exactly as you explained. They included some dumb dramatic crap in it, that a lot of doctors look at and say "what a load".
Just as an FYI, my nephew josh has had severe asthma all his life. Nothing has ever got the job done for him. He uses advair and loves it! He's never been more symtom free. I think that's great, and if your in the same boat, I think you should continue to follow your doctors orders.
My biggest beef is that doctors are giving this medication to Mild persistant patients, who don't need two medications, but they do because they are lazy. Glaxo has made it so easy for them. I ask doctors all the time. Before Advair did you write Flovent, and serevent for every patient, and they always say no. I ask them why they do now, and they say it's just easy.
All the while Glaxo gets paid for both products every time a script for advair gets written. Anywhow, I'll get back to you later with those studies. Got to run one of my boys to baseball practice.
Thanks again Sean. I wondered if people might be exhaling into it. My doctor made a point of stressing how important it is to use it the right way, so I'm now pretty obsessive with it. My biggest concern is pressing the lever twice and double-dosing.
I didn't know that about Provental HFA. Unfortunately, with my prescription plan that's way more expensive than generic albuterol. Luckily I don't need it that often, so it's full. I also play it safe and buy a new one at least once a year.
Appreciate your blog,i have a victims support page against Eli Lilly for it's defective Zyprexa product causing my diabetes.--Daniel Haszard www.zyprexa-victims.com
Hey, just found your blog on a Google search for Advair side effects.
I was diagnosed with asthma in January (almost 6 months ago) and I'm 25. I assume it's mild asthma, because I never had an attack per se, but was feeling constantly short of breath (the diagnosis was made after a full PFT, so I'm not worried that it is incorrect).
My Dr. perscribed Advair from the start, and the horrible cough I get after taking it is reason enough to get me looking for something else. With your information about serevent, I'll ask my Dr. about something more simple, given how mild my case is.
Thanks for the info!
Doctors use this site for reliable clinical drug information. Try http://online.epocrates.com/u/10a1444/Advair+Diskus
Sean must be a drug rep for Merck or Schering, so not sure his feedback will be that useful and his awareness of studies and physician interactions regarding use of these medicines is hidden in his comments. If he has a biased view, he should state it, and frankly, you should rely on your doctors knowledge of your clinical history, not a drug rep posing as an "interested person".
From Kim...
My 13 year old daughter was prescribed Advair recently to improve her sport-induced asthma. After eight days of taking this drug she was not sleeping, she was delusional, weepy, depressed, and fearful of everything. This drug put her in a desparate state. so much so that I saught psychiatric help for her. Eight days off the Advair and she is a perfectly normal 13 year old. Anyone else out there with such severe reactions to this drug?
I started off on Flovent in August of 06 as of Feb07 I am on Advair 500/50 I thank God everyday for it other wise breathing was almost impossible. I just wish it wasn't so costly $249.00 ouch.
Hi, you should move to the UK where the NHS (national health service) charges about 13 dollars for any prescription, or you can pay 66 dollars for 3 months worth of any amount of prescriptions. In my case, 3 Advair (in the uk, Seretide); 3 ventolin (flovent) 3 cetirizine, antibiotics, a spacer, a peak flow meter. Despite Blair it's still got some advantages...
Advair is a miracle drug! It is worth the risk for me. I struggled with asthma as a kid. I used to wake up every night several times with symptoms, and had to use a rescue inhaler each time. During the day I used it at least twice. I had to take oral steriods during the winters, when my ashthma was get so bad I had to sleep sitting up. Advair came out when I was eighteen and it changed my life. I no longer wake up at night wheezing. I don't have to use a rescue inhaler much, even for exercise! If I had been able to take this drug as a child, my life would have been easier!
Sean is quite correct. To add, Advair like most drugs should be used for a specific patient population, clinical trails showed it worked poorly in copd patients with poor reversibility. Also serevent itself ( one of the components of advair)had "safety issues" when people were using it as a rescue med like ventolin, due to its poor onset of effect, this was after a few deaths.
Advair should ideally be used alone with controlled asthma. Ventolin /Salbutamol can be added as needed for fast effective rescue when more probematic reversable air way disease is present.
Also there should be no mentioning of MDI (metered dose inhalers ie: puffers) useage without the use with a spacer device !!
Using an MDi without an aerochamber is wrong and archiac and proper use has always been a big issue with self administering of MDIs out of hospital.
A good blog and I just thought id would give my two bits
J.E. Canadian RRT
I'm an idiot that smoked for more than half my life, I started at 13... I'm now 31. I quit smoking on and off. To top it off, I started getting asthma symptoms when I was around 17... and it got serious about 23+ to today.
I now have exercize enduced asthma, I can't breathe at all without advair. It truly is a miracle drug, and it has literally saved my life. Sometimes, I feel that it's such a miracle drug because of the fact that I know I'd be dead right now without it.
Inhalers don't do me any good and it just irritates my throat severely; so much so that it feels like my breathing gets worse.
Anyhow, I'm very thankful for Advaire and have never had a side effect with it yet. None. Weight gain I have is from me being lazy ;) Not from Advaire. Thank you Advaire!!!
I am a 21 year old male and I don't have asthma. However I have had very bad allergies to pollen and pretty much everything green. I used to blow my nose at least 2-3 times a minute and I had been coughing all the time. Im kind of lucky becasuse, I get all brand name drugs for 9 dollars and generic drugs for 3 dollars with my health insurance (Tricare Reserve Select). I love Advair. It's awesome. I've been able to breathe much better ever since I started taking it.
I also am taking Allegra D, Singular, and Flonase. When I use Advair with these three drugs my allergies are almost nonexistant. I might blow my nose 3-4 times in a whole day maximum. My chest and my breathing feels much better when I'm running. Before I was on the medicine my chest would get very cramped up cause its summer and breathing in all that pollen was killing me.
But Advair isn't just for people with severe or mild asthma. I don't even have a mild case of asthma. Once again I just have bad allergies, but not anymore thanks to ADVAIR, Flonase, Allegra D, and Singular. I hope this story helps anyone out.
P. S
Oh and as far as the puffer and the diskus go. I like the puffer a lot better because i feel that i get more of the medicine in my lungs when i take it. However the pharmacy i go to only had the diskus Advair. So i just got that. If you know how to use a puffer inhaler type and your going to get Advair, I would definitely go for the puffer instead of the diskus
I've had asthma most of my life and have been on just about every one of the common medications: ventolin/albuterol (via puffer & nebulizer), Atrovent, Pulimcort, Bricanyl, Flovent & it's nasal inhaled cousin Flonase, also in bad times I've taken oral corticosteroids or IV administered in hospital (cortisone, prednisone, solumedrol) and also the 2 new "stars" on the block: Symbcort & now Advair.
LONG STORY SHORT: about a month ago I had the worst asthma attack of my life. NOTHING HELPED: I took back to back Albuterol masks (nebulizer) as had been administered to me as a kid at hospitals (I have a home neb kit) plus because of the panic I also took several puffs of Albuterol ont he way to the hospital.
By the time I got to the hospital my blood pressure was so high that they could not give me any more albuterol, so they gave me inhaled Atrovent. I was in the hospital for a week on IV steroids (IV of Solumedrol ("liquid Prednisone") bag changed every 4 hours... BIG DOSE)
When I got out of the hospital I made a resolution to not let this happen again. It seemed every doctor (LITERALLY: every single one!) was trying to push Advair. I had tried Advair in the past but on my first puff I got severly nautious, lethargic, shaky (far worse than Albuterol shakes) and severly dizzy. Needless to say: I WAS RELUCTANT to try it again.
I have been on Advair for just over a month. It's easily the best Asthma Med I've tried (I almost forgot I had asthma!) but I ABSOLUTELY HATE IT. It gives me a headache like my head is stuck in a vice. The blurry vision and nausea are usually bearable, but it seems some days, depending on if and what I eat for breakfast they can get REALLY BAD (it's ALWAYS the morning puff that does it). I've had to miss 4 days of work in one month because of this.
Yesterday I was on my way to work after eating just an apple for breakfast. I took my morning puff and felt the effects within 10 minutes. The headache, nausea and dizzyness. BUT THIS TIME THEY WERE FAR WORSE. I could barely walk I was so dizzy.
For 24 hours I could not eat or drink anything. Taking an anti-nasau drug (Gravol) with the equiv of 2 Tablespoons of water made me puke. I was even puking when there was nothing left in my stomach, a painful, scary, condition.
My only comfort (barely that) was lying in bed, face down, in a cold room. But every time I got up the symptoms started up again.
In the middle of the night I woke up extremely weak (much weaker than I should be after just 24 hours fast, I'm 29 years old!) with this numby tingling in my whole body, especially my arms and hands.
It's now close to 40 hours and I still feel weak and eating or drinking anything is still a struggle (not sure if thats drug induced or just a response to a full day of puking every time anything entered my mouth).
I've missed another 2 days of work because of this...
I'm going to change my regiment to Flovent + Atrovent (a long acting dialator that I've responded positively to) or see about this Singulair pill asap. NO MORE ADVAIR for me...
BTW: I'm 99.9% sure that Serevent is the culprit. It's the one drug that I'm new too (haven't taken it before), the Steroid (Flovent) ingredient is one I've taken for years with little to no side effects.
PS: Doctors and Pharmacists have been USELESS (and I'm one that has tremendous respect for these professions, I don't say this lightly) - I WAS NEVER WARNED OF *ANY* SIDE EFFECTS! WHEN I TOLD THEM I WAS SHAKING, HAD HEADACHES AND NASEA THEY BLAMED IT ON THE ALBUTEROL (which I have been taking for 20 years without incident, and that I barely take since being on Advair). I was told REPEATEDLY: Advair doesn't cause shakiness and advair can't cause naseau...
I'm not sure what is worse, that I have to go off this drug that has been great for my asthma but disasterous on my life, OR that I've absolutely lost faith in much of the medical community!
Good luck...
March 27, 2009 My 12 year old son had a severe adverse reaction to Advair (wheezing and severe difficulty breathing) after his pediatrician gave him 3 puffs of it. Three because he thought the second puff came out of my sons mouth. The doctor was in a big hurry so he rushed out of the room afterward. He left us with the Advair inhaler (in it's box),prescibed an antibiotic and told us to call him Monday.
My son began complaining almost immediately that he felt it was harder to breathe. We left the doctors office and not even 5minutes into the drive home he began complaining and I could hear him wheezing. He was not wheezing at all before we went to the docotor. He said he was scared and felt like he might stop breathing. I turned the car around and headed back toward the doctor office and the hospital which was right next door to the doctor.
I spoke to the pediatrician's nurse on my cell phone who told us we could come back there. The doctor saw him right away and said he wanted to give him a breathing treatment. My son was getting really upset and held back his tears trying not to scare his 1 year old sister on my hip. I asked the doctor if I should just take him to the ER and after he gave him the breathing treatment he agreed he should go there. He thought my son might need oxygen.
I informed the ER nurse and doctor that my son was given Advair. They checked his blood oxygen and it was good so they gave him a chest X-Ray. The whole time my son was not feeling any better. They said the chest x-ray was fine. The nurse explained how he himself has asthma and Advair makes him feel anxious, so that is probably what he was feeling. The ER doctor diagnosed him with bronchitis and released him. Prescribing my son Flovent instead and telling him not to use the Advair.
My son slept on the car ride home and felt much better 3 hours after he was given the Advair. My son does not have a history of asthma. He does have seasonal allergies.
I took him to the doctor 2 weeks prior to this incident because he had a terrible croup cough, stridor, and was having trouble breathing, wanting to sleep all day long. We were told he had swelling in his trachea and was put on an oral steroid for 5 days.
His breathing was better but his cold and cough didn't go away. So, two weeks after the first doctor visit I had taken him back because of severe sleepiness and a persistent daytime cough.
After looking up facts about Advair and it's side effects I am just thankful my son is ok.
Just found your blog and am surprised at this. I don't know where i was in 2006 when this news came out. I wasn't diagnosed with asthma till July of '06, and then it was mild. I was prescribed Singulair and a rescue inhaler. This winter that combo didn't work any longer. I finally sucked it up and called the Doc. My spouse has been on Advair successfully for years. So Doc said, 'go ahead and add it, don't subtract any other meds." Now I'm on advair, singulair and zyrtec (constant allergies). The combo is working the only side effect I'm noticing is mild heartburn.
Weird though. My second day on the advair we discovered the discus was malfunctioning. Both spouse and I had the jitters, some breathing issues, sort of felt an out-of-body experience in that the body was all jacked up, but the mind was calm. It was very bizarre. I told spouse, and he said, "Wow, that's how I feel. Must be a bad diskus. We called the pharmacy and they told us to stop immediately of course, take a couple days off. They shipped us new diskus'. I restarted after about 4 days off, and never had that feeling again. I've had many friends who suffer from asthma claim great relief and no or few side effects from advair. For me it's a life saver as I'm able to run 1/2 marathons again.
Last week my sister visited me fom California (I live in NY), she had these really weird facial grimaces going on. I haven't seen her in a long time so I was quite takern aback by her quirky facial expressions. It was easier to talk to her if I didn't look at her. I found out that she had asthma and that she was taking advair. I had told her about human grade fossil shell flour which had helped a friend of mine who had asthma all of her life and very strong allergies. After 2 days of taking the fossil shell flour her allergies and asthma went away. We were surpirsed because she was taking the fossil shell flour for an entirely different reason. I told my sister this story and she wanted to try it. Well amazaingly she was able to stop her advair the next day. She has being taking the fossil shell flour for almost 2 weeks now and she can not believe that she can now run. The grimacing she was doing with her mouth stopped a day after she stopped the advair. I am not a drug person (except in emergencies). My sister is now planning on weaning herself off of all of the other meds that she is currently on, instead using holistic approaches. Please look up fossil shell flour (food grade), it is amazing, perhaps even a life saver!! For those with asthma it rebuilds your lung tissue!
God Bless!
Post a Comment