Skip to comments.FDA to Change Labeling for Long-Acting Beta-Agonists (for asthma)
Posted on 04/05/2010 11:31:31 PM PDT by neverdem
The Food and Drug Administration is requiring major changes to the prescribing information of inhaled long-acting beta-agonists as part of a risk management plan to address the ongoing safety issues associated with the products' use in children and adults with asthma, the agency announced at a press briefing.
Safety concerns regarding long-acting beta-agonist (LABA) therapy date back to a major study reported more than 7 years ago and include a 2008 FDA meta-analysis, which indicated that treatment with LABAseither alone or when combined with an inhaled corticosteroid (ICS)is associated with an increased risk of severe asthma symptoms and hospitalizations as well as deaths in children and adults with asthma, when compared to people not on a LABA.
The LABA products approved in the United States are Serevent (salmeterol) and Foradil Aformoterol), which contain the LABA alone, and Advair HFA(salmeterol plus fluticasone) and Symbicort (formoterol plus budesonide), which contain the LABA and an inhaled corticosteroid.
Previous efforts aimed at managing these risks, including the addition of a boxed warning in 2003, have not adequately addressed this safety issue, so the FDA is now requiring changes to the drug's label as part of a risk evaluation and mitigation strategy (REMS) for these products. The label changes are intended to better inform health care providers and patients asthma about the risk of LABAs and the way they can decrease these risks while maintaining the benefits of these drugs, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER) said during the briefing. The required label changes are as follows:
▸ LABAs are not asthma controller medications and are contraindicated without the use of an asthma controller medication, such as an inhaled corticosteroid. Single-agent LABAs should be used only with a controller medication, never alone.
▸ A LABA should be used only as long-term treatment in patients whose asthma cannot be adequately controlled on asthma controller medications.
▸ Children and adolescents who need a LABA with an ICS should be prescribed one of the combination products, to ensure that a LABA is not used alone.
▸ LABAs should be used for the shortest period of time possible to achieve symptom control. As soon as a patient's asthma is under control, the LABA should be discontinued if possible, and the patient should be maintained on an asthma controller medication, such as an ICS. This is a change from current asthma treatment guidelines.
The REMS for these products includes a revised medication guide for patients that explains the product risks with each filled prescription, a plan to educate health care providers about the appropriate use of LABAs, and a requirement that the manufacturers conduct more studies of the safety of the LABA-ICS combination products; currently there are insufficient data to conclude whether LABAs combined with an ICS reduces or eliminates the risk of asthma-related death and hospitalizations, the FDA statement said.
In addition, under a new drug safety initiative the FDA will be monitoring use of the medication to determine whether LABAs are still being used without a controller medication.
The new requirements do not apply to the use of LABAs for chronic obstructive pulmonary disease or intermittent exercise-induced broncospasm.
The full statement is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm.
As a result of a bout of bronchitis, I got a temporary case of asthma and was prescribed a salbutamol (more short acting than the related medications listed above) inhaler to open up my lungs.
It raised my eyebrows a bit to see on the medication package insert that studies show more fatal asthma events occur with salbutamol inhalers than without them. Whether this is because the worse off patients get inhalers more often than those with mild cases, I wouldn’t know.
Also maybe you or some other doctor in the house can answer a question about salbutamol inhalers. For many days after taking a puff of one of these inhalers, when I would cough up phlegm I would get a markedly putrid odor in my nose. Kind of like battery acid, kind of like dead insects or honey but powerful enough to make me gag. The odor would die down after about a week. The puff from the inhaler itself was quite odorless and flavorless to me. It’s like some kind of junk was getting formed from the medication and/or its vehicle in my lung, and it was not getting readily cleared back out. I wonder what the odorous substance was.
I had asthma— pretty severe— as a kid, and as most do, grew out of it. It seems to be coming back now; I’m in my early 50’s.
The meds I took as a kid are no longer prescribed— they involved some amphetamine combined, I think with phenobarbital, supposedly to counter the effects of the former. One of the drugs was called Tedral and it kept me in a constant semi-dazed state.
I guess it was 12 or so years ago that I was taking anatomy and physiology. The Doc teaching the course remarked that asthma was associated with the sympathetic/parasympathetic nervous system; that stimulating the sympathetic system caused the airways to open. That was why speed was used to medicate it, and why kids with asthma should be encouraged to participate in sports. That squared with my own experience. (By the way, I think I’m getting this right, the sympathetic pathways are the ones that get you “up,’ parasympathetic responses get you ‘down.’ Physically, I mean. I think. The sympathetic response, paradoxically, doesn’t make you very sympathetic.)
Some years later I’m talking to my cousin’s wife. Both are real doctors, and we’re talking about asthma. Her kids had it. I recounted the foregoing theory and she told me that the new drugs did none of those things, that the new approach is to treat the condition as an inflammation. “It’s much better now, besides, that other stuff had speed in it, it’d make you crazy.” She’s very frank.
And maybe so. Crazy enough to venture a reply on something I know just enough about to make a fool of myself.
Let me know me know how well I’ve succeeded. I am curious and would like to compare notes.
Do you eat Chinese food? And I’m completely serious. I once ate some egg-drop soup that was “not right” and I had a rotten smell in my nasal passages that lasted for months.
I’m currently using an albuterol inhaler (an emergency medication) and Advair(for maintenance of symptoms). After a recent dust storm, my symptoms quickly got out of control. Without the Advair, I would have been in the hospital for a long term stay due to bronchial inflammation.
Haven’t touched Chinese in months.
Sorry, but I don't know.
I wonder how much would now be diagnosed as exercised induced bronchospasm or exercised induced asthma?
I guess it was 12 or so years ago that I was taking anatomy and physiology. The Doc teaching the course remarked that asthma was associated with the sympathetic/parasympathetic nervous system; that stimulating the sympathetic system caused the airways to open. That was why speed was used to medicate it, and why kids with asthma should be encouraged to participate in sports. That squared with my own experience. (By the way, I think Im getting this right, the sympathetic pathways are the ones that get you up, parasympathetic responses get you down. Physically, I mean. I think. The sympathetic response, paradoxically, doesnt make you very sympathetic.)
I can live with that description of the autonomic nervous system.
Some years later Im talking to my cousins wife. Both are real doctors, and were talking about asthma. Her kids had it. I recounted the foregoing theory and she told me that the new drugs did none of those things, that the new approach is to treat the condition as an inflammation. Its much better now, besides, that other stuff had speed in it, itd make you crazy. Shes very frank.
Inhaled steroids for chronic inflammation in the lungs is the latest standard of care, IIRC.
And maybe so. Crazy enough to venture a reply on something I know just enough about to make a fool of myself.
Let me know me know how well Ive succeeded.
Overall, fairly well. They have been backing off drugs like salmeterol, long acting drugs that inhibit bronchoconstriction in the lung's smooth muscles for a while now.
I could be wrong.
I use Advair for COPD. It works but the side effects include muscle and bone pain which can be really unpleasant. That is why I’m awake right now, hurts too bad to sleep.
FReepmail me if you want on or off my health and science ping list.
In any case, I take the whole 9 yards. Advair (2x daily) and Spiriva (1x daily) for the longer term and Combivent every 4 waking hours. Of course, I have Albuterol and a nebulizer for very bad times. Too much sometimes, I think.
anyway, seems like I'm getting worse, but suspect I just need to push myself and exercise/maybe workout. Too sedentary, I'm afreaid.
Why not start walking for exercise?
I read this yesterday. I'm not implying you're depressed or have anxiety, although a chronic diagnosis is no cause for joy. I just thought the excerpt might help.
"Rather than emphasize the long-term health benefits of an exercise program which can be difficult to sustain we urge providers to focus with their patients on the immediate benefits," he says. "After just 25 minutes, your mood improves, you are less stressed, you have more energy and you'll be motivated to exercise again tomorrow. A bad mood is no longer a barrier to exercise; it is the very reason to exercise."
Is there any chance that you have an osteoporotic compression fracture from the steroid in Advair? Maybe you should see a doc.
I have had asthma forever. Treated as a child/teen...then thought I had ‘outgrown it.’ Every chest cold though, for me, hung on for months with coughing and wheezing (but I was young and could get over it). After having a few babies my symptoms worsened in my 30s (pneumonia, pleurisy) and was just given a rescue inhaler. I am now in my 40s and have ‘leveled’ off. I take Allegra (daily of allergies); Singulair (nightly for the asthma); and Nasacort (rx nasal spray); still also have a rescue inhaler (Proventil). This mix works...except...
When I go for my check up, more time is spent discussing the possible side effects of the Singulair (dark thoughts? depression? thoughts of suicide?) than talking about my actual asthma issues. The Singulair bottle comes with four ‘stickers’ worth of warnings. Fortunately, I have had no problems, but then I wonder...’what happens if I have to stop taking this?’
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