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Medical Forum / Diseases and Disorders / Asthma / April 2006Warning: Advair etc.
See http://hosted.ap.org/dynamic/stories/A/ASTHMA_WARNINGS?SITE=KYLOU&SECTION=HOME&T EMPLATE=DEFAULT Mar 6, 6:04 PM EST Advair, other asthma drug get label alerts By ANDREW BRIDGES Associated Press Writer WASHINGTON (AP) -- The asthma medication Advair and a related drug will bear stronger warnings of an increased risk of death associated with one of their ingredients. The revised warnings apply to Advair and Serevent, Food and Drug Administration spokeswoman Laura Alvey said Monday. Advair is GlaxoSmithKline's best-selling product, and Serevent is another of the British company's drugs. The updated versions of the "black-box" warnings on both drugs caution that salmeterol, one of the active ingredients in Advair and the active ingredient in Serevent, may increase the risk of asthma-related death. Black-box warnings are the most severe warnings the FDA can require of prescription drugs. Advair should be used only by patients when other asthma drugs, such as low- to medium-dose inhaled corticosteroids, don't work or if their asthma is severe enough to merit use of two medications, the revised warning says. As for Serevent, it should only be used as an additional medication when the low- to medium-dose inhaled corticosteroids aren't sufficient or, again, if the asthma is serious enough to merit use of two drugs. The FDA in November asked that the labels be updated for the two drugs, along with a third, Foradil. Foradil's manufacturer, Novartis, remains in talks with the FDA and no final decision has been reached, said Julie Lux, a spokeswoman for Schering-Plough Corp., which markets Foradil in the United States. GlaxoSmithKline said in a statement that it was pleased to reach an agreement with the FDA on the label changes to its two drugs. "The new product labels communicate the benefit-risk profile of Serevent and Advair and help guide physicians in making appropriate prescribing decisions," the company said. In November, however, it maintained that the drugs already came with sufficient warning. The company reported in February that sales of Advair, sold as Seretide in the United Kingdom, rose 22 percent last year to $5.2 billion. The FDA last Friday released new medications guides for patients using the two GlaxoSmithKline drugs. The letters urge asthmatics using the drugs to talk to their doctors about the relative risks and benefits of the medicines. The agency said a large U.S. study found that more people using the asthma drugs died from their asthma compared with those taking dummy medication. The number of asthma deaths in the study was small, however: just 13 out of 13,176 patients. The drugs help with long-term control and prevention of asthma symptoms like wheezing and shortness of breath. They help the muscles around the airways in the lungs stay relaxed. Regards, Richard Friedel That is a great warning, but unfortunately most people on this board refuse to listen to it. There is another warning burried deep in their literature under "cardiovascular",,, it states that "Advair can cause a change in the heart rhythm". They don't come right out and say that asystole and v-fib are a just a few of the "changes in the heart rhythm". Advair is dangerous, and we suspect that it is what killed my father. The FDA agreed with me, but told me that not enough people have died yet, so they can't take it off the market. A month before he died, my father told me that Advair had changed his life. At that point, he didn't realize to what extent. Thank you for posting this warning. I thought that I was the only one that dislikes Advair. What about Symbicort? Is that and Serevent just as dangerous then? I have been on Symbicort for a month now and it is the only thing that is keeping my asthma under control after 3 emerg visits and being on prednisone 2 times in 3 months. The respiratory therapist said my asthma is now under good control on this drug... Meghan > That is a great warning, but unfortunately most people on this board > refuse to listen to it. [quoted text clipped - 12 lines] > Thank you for posting this warning. I thought that I was the only one > that dislikes Advair. > What about Symbicort? Is that and Serevent just as dangerous then? I > have been on Symbicort for a month now and it is the only thing that is [quoted text clipped - 3 lines] > > Meghan I don't think anyone knows. If one assumes that it is the beta receptor stimulation causing problems then one would have to assume there are similar risks with all of the agonists including the formoterol in Symbicort and albuterol. Thsi, of course, leads to al kinds of issues such as whether the long acting meds are worse than taking the short acting ones several times per day. How all that compares to uncontrolled asthma is another issue. Really, with very few exceptions drugs cannot be termed "good" or "bad". They all have their pros and cons and whether it is worthwhile to take depends on the individual case. Also, nearly all the side effects (like lethal heart rhythms) happen in people who never took the drug. Even if it is well established that the drug increases the risk of something happening (not that this is the case here) it is usually hard to tell if it is what caused the problem in any individual case. Basically, asthmatics should virtually never take a long acting beta agonist (Serevent/salmeterol or formoterol) without an inhaled steroid. What to do if moderate doses of inhgaled steroids are not adequate, whether to add a long acting agonist vs increase the steroids to high levels vs add another med, is not clear right now and will probably be different in different situations. I agree that my preference is to maximize the anti-inflammatory therapy.  Signature00doc -- 00doc Thanks. I was on Fovent 250 mcg 2 puffs twice a day and still ending up in emerg. So now I am taking Symbicort 100/6 two puffs twice a day and Singulair (which my doc said is now going to have a warning about it causing liver problems for some people...). Now that I am off the Flovent and on the new drugs it has made a huge difference in my life. Flovent worked well for me for many years and I actually took quite a low dose but after the birth of my second child everything went crazy. I guess we will just have to wait and see what the future holds for asthma treatment! For now I am just happy that I can breathe well once again. Meghan >> What about Symbicort? Is that and Serevent just as dangerous then? I >> have been on Symbicort for a month now and it is the only thing that is [quoted text clipped - 27 lines] > different in different situations. I agree that my preference is to > maximize the anti-inflammatory therapy. I think everyone should heed this new FDA Advair warning. The last 2 warnings I brushed off and did not take seriously. Last Fall after 4 1/2 years on Advair I noticed that I was breathing heavier almost panting with any exertion but dismissed this symptom for awhile. Then in the next 6 months I noticed that I rarely used my inhaler but then I would have a really bad attack a couple times a month. I think the Serevent was covering up my symptoms of an impending attack because I no longer wheezed or had chest tightness. I would just wake up one day having a terrible time breathing and my peak flow reading would be in the red zone. I then started using my peak flow meter everyday and start noticing that my asthma was deteriorating according to my readings and so I knew the Serevent had to be the reason. I had my doctor take me off the Advair and put me on an inhaled corticosteroid called Asmanex. Now if I happen to have an attack it is minor, my body tells me with symptoms like chest tightness that I am having an attack, I do my inhaler and problem solved. Before my attack had silently gone on so long that I had to use a nebulizer for several days to get back on track. With Advair my asthma was totally out of control. ncchinagirl I'm glad that you have found meds that are working for you and that you are happy with them. I'm also glad that you come here and share your experiences. But (you knew that had to be coming)...... 1) Meds that did not work for you or caused you side effects are not defacto "bad" or inferior to other meds. Different people respond differently. 2) You have made your views on Advair clear and are starting to fall into the tiresome droning category. Signature00doc > I'm glad that you have found meds that are working for you and that you > are happy with them. I'm also glad that you come here and share your [quoted text clipped - 3 lines] > defacto "bad" or inferior to other meds. Different people respond > differently. I've been on Advair for 3 years now, I think. Nothing I was on before worked and even though I was using inhalers and swallowing pills I still couldn't breathe, still couldn't walk without reaching for the albuterol inhaler (which did nothing). My doctor then took me off Azmacort and put me on Advair and within two days, I could walk without wheezing. For me, it truly was a miracle drug. Instead of using albuterol every hour every day I think I've used it 1 or 2 times in the past 3 years. My quality of life is 1,000% better since I started Advair. They can put any warning they want on it but I don't want to give it up. -- Liz > "00doc" <00doc@comcast.net> wrote in message > > 1) Meds that did not work for you or caused you side effects are not [quoted text clipped - 13 lines] > -- > Liz Yep, when it works it's a miracle. I had a similar experience with Singulair. Before I took it light yard work or running a few blocks made me wheeze and gasp for air. Very scary. As soon as I started using Singulair that all changed. That was 5 years ago and today I still can run 3 or 4 miles with no symptoms. For me that's a miracle and like you I would not want to give it up. However, I have seen postings here where Singulair did absolutely nothing for some people. To me that's sad, but it just proves that asthma is a complex problem. Generalizing a drug's effectiveness from a small sample is useless. -- Lou Pecora (my views are my own) REMOVE THIS to email me. > Yep, when it works it's a miracle. I had a similar experience with > Singulair. Before I took it light yard work or running a few blocks [quoted text clipped - 7 lines] > > -- Lou Pecora (my views are my own) REMOVE THIS to email me. Lou, I was on Singulair for awhile and it did nothing for me. I think I was put on Singulair by itself, then Azmacort was added and I might as well have been inhaling air and gulping a sugar tablet. My mother and other family members have also been on Singulair and my mother was also on Azmacort, and they didn't work for any of us. But, half my family has been on Advair as well and I know one of my nieces said it didn't help her and my mother's doctor recent;y increased her to the higher dose. Pretty much all of the females in my family have asthma and there's no one treatment or medication that works for all of us. -- Liz > Lou, > [quoted text clipped - 10 lines] > -- > Liz Very sorry to hear that. It's got to be frustrating at the least. This seems to me to be the theme of asthma: it has many variations in many people and there seems to be no way of telling beforehand what will and will not work. That's a lot of trial and error in store for asthma sufferers. I'm not knocking the medical establishment as a whole (I know some of you have axes to grind, but I don't). It just shows that a lot more research is needed. -- Lou Pecora (my views are my own) REMOVE THIS to email me. You write. " I'm not knocking the medical establishment as a whole (I know some of you have axes to grind, but I don't)." I'd definitely side with the ax grinders. Surely the masses of folks with inarticulate misgivings about the current, official presentation of asthma should not be so insulted. It seems much more likely that something with current asthma treatment is basically wrong - like perversion of breathing sensations by use of drugs and turning a blind eye to the role of nasal airflow resistance as a positive factor. Look and the pre-FDA record of the pharmaceutical industry. Who's to say that we and the FDA are not being outwitted by it? Simply a question of sophistication, not a change of heart, (and not a question of conspiracies either). In other words, your basic knowledge, your driver software, needs an update. Despite its abundant scurrilities, I'd recommend a study of yoga and its breathing techniques as basically sound. Regards, Richard Friedel > You write. > [quoted text clipped - 17 lines] > yoga and its breathing techniques as basically sound. Regards, Richard > Friedel Sorry, I really can't follow much of what you say. From my own experiences and those of others that I know and read about I think that we simply do not know a lot about various asthma related maladies. It's not so much that someone is wrong, but that a lot is unknown. IMHO. -- Lou Pecora (my views are my own) REMOVE THIS to email me. > Sorry, I really can't follow much of what you say. Neither can I. I'm not convinced he can either. > From my own experiences and those of others that I know and read about I > think that we simply do not know a lot about various asthma related > maladies. It's not so much that someone is wrong, but that a lot is > unknown. Certainly true. Signature00doc Abandoning my fourth pulminolgist at Columbia Presbyterian and going back to my second at Beth Israel. He seemed to want to do somethig beyond delivering up encouraging bedside manner. In these twelve years I've found out the lung doctors have a lot to learn. Shall try to survive while they're getting at it. Have cardiac problems. My real doc thinks I have pulminary hypertension. Seems to me the heart doctors more knowledgeable in their field than their respective lung doctor collegues. Am I right? >> You write. >> [quoted text clipped - 28 lines] > > -- Lou Pecora (my views are my own) REMOVE THIS to email me. That is very well put. Learning about any disease is a process, and that knowledge is often hard-won. That difficulty is no reason to discard the process in favor of wildly mystical approaches. As an example of normally unchallenged knowledge in the field see http://www.emedicine.com/ENT/topic696.htm, which makes the impression of meticulous scientific quality, to be accepted by any doctor without further proof. However it contains the dogma that a deep breath sort of "just happens" and does not correlate with any increase in nasal airflow resistance. This is contrary to common experience that doing a deep breath involves a distinct feeling of airflow in the nose. If this is feeling is absent and the same muscular inhalation effort is applied, the breath is much shallower. The need for suction during a deep inhale through the nose may be demonstrated by holding some plastic tube, such as flexible infusion tubing, in the mouth and observing how high water is drawn into the tube through the lower end. A small head for water correlates with a shallow breath and a large one with a deep breath. If it is not too belittling and undignified, try pinching the nostrils together during nose breathing. Leaving a greater flow cross section free for airflow is associated with a shallower breath and a smaller one is associated with a deeper one. This seems to be a reasonable proof of causality. What more proof, pro or contra, is needed? To remain on the practical, asthma-related side, doubling nasal airflow resistance by alternate nostril breathing (nadi sodhanna) helps overcome tightness of the chest, if the technique is done with this aim in view, i. e. fairly vigorously. Works like a spray with a little practice and should be safe if taught by a yogi with an MD. Regards, Richard Friedel > You write. > [quoted text clipped - 17 lines] > yoga and its breathing techniques as basically sound. Regards, Richard > Friedel You are the best evidence I have seen yet that articulateness and sophistication are not sufficient. Signature00doc >> You write. >> [quoted text clipped - 20 lines] > You are the best evidence I have seen yet that articulateness and > sophistication are not sufficient. I like that. |
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