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Physicians Weighing Patient Fallout Over FDA Panel’s Asthma Drug Vote
December 12, 2008 1:09 PM
By DAN CHILDS, ABC News Medical Unit
Some respiratory specialists around the country have reported a flood of calls from concerned asthma patients after yesterday’s news of FDA panel votes on the safety of four widely used asthma drugs -- Advair, Symbicort, Serevent and Foradil.
This has more than a few specialists worried that the news could needlessly scare many patients away from needed medication. The following are some of the comments that the ABC News Medical Unit has received from these physicians:
Dr. David Lang, head of the Allergy/Immunology Section at the Cleveland Clinic’s Respiratory Institute:
"We're seeing an impact already in the sense that patients have heard about this in recent days, have interpreted what they've heard (or read) to imply that the medications they're taking... are potentially harmful, and have called our office asking whether they should stop taking these medications for their asthma. I am confident there are even more patients who aren't calling and may be inclined to stop the medications on their own.
"There is a need to clear the air and get the proper message out: asthma outcomes are superior with combination treatment (Advair or Symbicort) compared with inhaled steroid alone for patients with moderate-severe persistent asthma; don't stop taking your medication; if you're concerned talk to your asthma care provider."
Dr. Clifford Bassett, assistant clinical professor of medicine and otolaryngology at The Long Island College Hospital, SUNY-HSCB, in Brooklyn, NY:
"I have seen a pick up in phone calls regarding patients and their asthma medications over past several days; call volume is up by at least 50 percent and [I] expect it to continue.
"Some [patients] are unfortunately panicky about whether to continue any of asthma medications and are just hearing ‘scary stuff.’ The reality is, virtually all of my asthma patients are on the correct medication for their asthma and are doing just fine as they are adhering to a comprehensive allergy/asthma action plan."
Dr. John Murray, professor of medicine and pharmacology at Vanderbilt Medical School in Nashville, Tenn.:
"The worst thing about this sort of publicity is that some people won’t understand all the intricacies of the analyses and stop their asthma meds... The possible upside will be that more asthmatics may understand the importance and take inhaled steroids."
(Indeed, Murray adds that the votes should not have a drastic effect on clinical practice, at least in the near future -- even when it comes to Serevent and Foradil, which received the least favorable votes among the drugs the panel examined.)
Murray:
"I don’t think that either will be removed, as they are both indicated for COPD as well... And if they ‘removed’ Serevent or Foradil, they would also have to remove Brovana and Performist -- and these weren’t even considered at the advisory meeting as they only have an indication for COPD [chronic obstructive pulmonary disease]."
(And still others believe the votes will have little effect on patients’ feelings about the drugs.)
Dr. Neil Kao, chair of the Rhinitis/Sinusitis Committee of the American College of Allergy, Asthma & Immunology:
"This vote will have a very small effect on my practice... A high percentage of patients in my practice have asthma. Their asthma is controlled without the use of individual inhalers of [drugs like Serevent and Foradil] almost always. As the decision was just announced, there probably has not been enough time for the news to percolate through the medical community and general public. Technically, my office has not fielded a single question so far."
December 12, 2008 | Permalink | User Comments (5)
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As an asthmatic since my late 30's, I used a rescue inhaler composed of albuterol sulfate. Then, as our air quality degenerated badly, I use 3 nebulizer delivered treatments daily of albuterol sulfate/ipratropium bromide, supplemented with one AM and one PM "puff" of an Advair discus. I do well. However, twice, I would have lost the battle without my rescue inhaler. My cousin, age 29, did not find hers in time. It had fallen from her pocket earlier. I hear the pharmacies are not going to file Medicare claims for inhaler use patients in 2009? Is this true? Truthfully, we all think Social security disablity, Medicare, and the Drug Giants who really rule the FDA and the doctors WANT to kill off all the COPD patients they can.
Posted by: Lizbeth | Dec 14, 2008 11:23:13 AM
After being prescribed Advair for a year, and after repeated bouts of pneumonia and bronchitis, I very gradually weaned myself off of it. -- I stopped the yo-yo games with lung infections, and have finally been feeling much better for the past two years. -- A young doctor recently told me that he might want me to start on the Advair again. -- He got angry with me when I said NO. -- I am beginning to wonder if our medical people really have our best interests at heart. -- Perhaps our medical paradigm needs revamping, entirely! -- Retain your MEDICAL RIGHTS, folks. -- Careful, because there are people trying to take them away from you. -- There is real danger here.
Posted by: Grrranny | Dec 14, 2008 12:19:34 PM
We are talking about a couple different types of medication here, folks. Serevent and Foradil are both long-acting bronchodilators (LABAs); they improve lung function for several hours instead of providing immediate or "rescue" relief. This type of drug is the 3rd line of defense in the war against asthma. Your rescue medication (albuterol or levalbuterol) is first line and if you need that more than once a week your doctor SHOULD be going to an inhaled steroid as the second line of defense. Inhaled steroids can be low, medium, or high dose and their job is to keep your upper respiratory system from overreacting to any and every stimulus. *Note-steroids do supress immune response (that's how they help you). If you are suffering from infections, make sure you have tried the lowest dose available before you quit completely. I have been on Advair and I couldn't handle the shakes and needing to eat 6x/day, so I wasn't on it long enough to have any other complications, but that is an example of combination steroid and LABA therapy.* If you are still overusing your rescue inhaler (uncontrolled) with an inhaled steroid, NAEPP guidelines recommend the addition of a long-acting bronchodilator. Many doctors skip the second step and go straight to this third-line combination therapy. That is why so many doctors and drug companies are emphasizing that these drugs are safe and even life-saving "when used appropriately." There is no need to be on a long-acting bronchodilator if your asthma is controlled with an inhaled steroid.
Ipratropium bromide works differently from both the above drug classes. Think of it as a slower bronchodilator that relaxes those muscles that contract when you panic. It should definitely be considered as an alternative for those whose immune systems are too weak for steroids, but does not work better or necessarily as well.
I believe what you're hearing about Medicare not covering rescue inhaler claims has to do with the changeover from CFC propellant inhalers to HFA propellant inhalers. Don't worry. Your rescue inhaler will still be covered. It will just be one of the "branded" HFA ones, like Xopenex HFA or Proventil HFA, instead of your generic albuterol CFC.
Posted by: Hope | Dec 14, 2008 10:11:23 PM
I was diagnosed with activity induced asthma at the age of 13. My meds for that really stopped working by the time I was 16, but since I was otherwise healthy, I never complained. It wasn't until college, when I began having frequent, unprovoked asthma attacks that I sought to rework my medical plan for caring for my asthma. I was put on an inhaled LABA and pill steriods. This combo never worked for me- my rescue inhaler wasnt even working well enough. I finally reached the point where I was spending whole days in a low grade asthma attack. It was impossible for me to draw a deep breath. That was when my doctors chose to try Symbicort. I use one puff, twice daily, and it has given me my life back. I breathe well for the first time in years. I haven't had an attack now in 4 months. I am glad to see the FDA did not recommend the removal of Symbicort for asthma sufferers. It is only one of numerous helth issues I have, and changing one of my meds can have an effect on how they all work.
Posted by: Marie | Dec 15, 2008 11:29:48 AM
nice article
Posted by: online pharmacy | Apr 15, 2009 6:21:43 AM
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