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February 18th, 2010
07:49 PM ET

FDA announces new asthma medication labeling

By Saundra Young
CNN Medical Senior Producer

If you are an asthmatic who uses long-acting beta agonists–or LABAs– to treat your asthma symptoms, your medication may be doing more harm than good.

The Food and Drug Administration announced new safety warnings Thursday saying the medications should never be used alone by children or adults. The agency says it will require manufacturers to add additional warnings to the product labels, and ask doctors and patients to scale back overall use of the drugs.

"Patients with asthma should try to get on a single-agent steroid inhaler," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "And not try to get on combination medications with LABAs unless they really need them"

According to the FDA, LABAs put asthma patients at increased risk of severe, worsening symptoms; they lead to increased hospitalizations and even death. The LABAs in question contain the single drug Serevent or Foradil and can be in the combination medications Advair and Symbicort, which also contain inhaled corticosteroids. Corticosteroids supress inflammation and help reduce symptoms in inflammatory ailments such as asthma and arthritis. Advair contains Serevent, whose active ingredient is Salmeterol. Symbicort has Foradil; its active ingredient is Formoterol.

"Although these medications play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death." said Badrul Chowdhury, director of the Division of Pulmonary and Allergy Products at the FDA's Center for Drug Evaluation and Research.

Children are of particular concern, said Dr. Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics. "Parents need to know that their child with asthma should not be on a LABA alone."

The new labels will warn that:
*LABA use is contraindicated unless used with asthma controller medication such as an inhaled corticosteroid. Single-agent LABAs should be used only in combination with an asthma controller medication, never alone.

*Long-term use should be only in patients whose asthma can't be controlled by controller medications

*LABAs should be used only for the shortest amount of time possible, and discontinued once asthma has been controlled. Patients should then be maintained on an asthma controller medication.

*Pediatric and adolescent patients who need a LABA in addition to inhaled corticosteroids should use a combination product that contains both a LABA and an inhaled corticosteroid

Novartis, maker of Foradil, released a statement saying, "Novartis and Merck will work closely with the FDA to assess the guidance provided in the Communication and determine appropriate next steps. We are committed to helping ensure that healthcare providers and patients have the most accurate and complete information regarding the safe and appropriate use of FORADIL. We will continue communicating with patients, caregivers and healthcare providers about FORADIL in ways that will help inform their decisions about appropriate treatment choices."

GlaxoSmithKline (GSK), which makes both Serevent and Advair, says it has 30 days to agree with the proposed changes - or say why they aren't necessary.

"We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease," said Dr. Katharine Knobil, vice president for Respiratory Clinical Research at GSK. "It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma."

According to the FDA, in a 2008 trial of more than 13,000 patients who took Salmeterol, there were 13 deaths. But GSK says in 10 years of clinical studies, there were no asthma-releated deaths in the nearly 18,000 patients who took Advair.

Drug makers will now have to do additional safety studies that look at LABAs when used with inhaled corticosteroids. And, the agency says it will continue to scrutinize prescribing patterns to make sure the new safety controls are being followed. LABAs are also approved to treat people with chronic obstructive pulmonary disease or COPD. However, the new recommendations apply only to treating asthma patients.


soundoff (118 Responses)
  1. Gwen

    Everybody – your comments are so welcoming and re-assuring. I felt I was alone in my world of breathing problems – more so because I look healthy and energetic but no-one knows the amount of medicines I have to take to control my asthma since childhood.
    I was overdosing bigtime on Albuterol for years – 4 inhalers per month and needing more. For the past year I have been on Symbicort and Singulair but still use my Albuterol to help – but the panic has gone. It's made a world of difference and I hope that I can eventually cut back too – as some of you have apparently been able to do. Blessings to you all!

    February 23, 2010 at 11:04 | Report abuse | Reply
  2. Alexander

    First, lets not forget that asthma consist of both bronchial constriction and inflammation. The inhaled steroids treat the inflammatory component of asthma while the bronchialdilators treats the bronchial constriction component of asthma. It is paramount to treat both components of the disease to effectively treat asthma.

    Second, and unfortunately, there are political undertones to the guidelines and this very article. For instance, pharmaceutical companies have capitalized on the findings of the SMART (Serevent Multi-center Asthma Research Trial) study referenced above regarding 13 deaths out of 13,000, which raised many concerns about the safety of Advair since it has Salmeterol. As a result, pharmaceutical companies have lobbied aggressively to rewrite the guidelines that would benefit their agenda. For instance, Schering-Plough, the maker of Asmanex, lobbied the FDA to influence the notion that a bronchialdilator is not necessary unless the patient is not controlled. Simply put, a bronchialdilator should only be used as an add on, but should not be used as a first line of treatment. However, by implementing this approach, you fail to treat both components of asthma for superior control. Most studies, suggest that asthma is both inflammatory and bronchial constriction. Even the article above has a misleading tone, which explains the confusion. It is important that you understand the issue and the competitive landscape.

    Without getting too technical, patients that were taking the medication in the SMART study were given Salmeterol (bronchialdilator) and Flovent (inhaled steroid) separately. Unfortunately, the 13 participants that died were taking Salmeterol as a rescue medication and failed to use Flovent during the study. In other words, participants that died were taking Salmeterol alone as a rescue medication and failed to take Flovent inconjunction with Salmeterol as the study intended. The other issue is that Salmeteraol is not a rescue medication and has an onset of 30 minutes compared with a rescue medication which has an onset of approximately minutes. In my opinion, compliance was the culprit in the study and not the medication.

    Essentially, Salmeterol masked the inflammation and patients felt better when in fact they where drowning, which lead to their death. This finding is nothing new. If you treat asthma with a long-acting bronchialdilator alone or a short-acting bronchialdilator alone, you will eventually die. It is simply a matter of time. The SMART study just confirmed what was already known.

    The study was designed to determine the safety of Salmeterol not advair. Just because Advair has Salmeterol, it cannot be extrapolated that Advair is not safe, however, this is exactly what many pharmaceutical companies have lobbied for and want patients to believe that combination therapy is not necessary or safe. There is simply no study that concludes that Advair or Symbicort are not safe when used properly. Advair and Symbicort contain both inhaled steroids and bronchodilator, which are administered together and cannot be separated. This method assures compliance.

    Most deaths with any disease can be rooted to compliance.

    Link to GlaxoSmithKline's press release regarding their study.
    http://www.gsk.com/press_archive/press2003/press_01232003.htm

    February 24, 2010 at 09:19 | Report abuse | Reply
  3. Barbara S

    I have had asthma since I am ten years old and have used many drugs over the years – Marax, Theodur, etc. My life completely changed when I started a regimen of Asmanex and Serevent along with Singulair. My asthma symptoms are almost non-existent and I can live a normal life – exercising, running, etc. I do not think of my asthma most days – but always have my emergeny inhaler with me – rarely use it. I am allergic to many things – dust, ragweed, mold, dog dander.

    My concern is long term use of these drugs – bone loss and increased appetite and weight. It is hard to get information regarding this – I have been using this regimen of Serevent, Asmanex, and Singulair for about ten years or so. I do have hard time with my weight and cannot find concrete information to document this side effect. I have noticed weight creeping up on me and have a hard time controlling this. Also I am concerned about bone loss with the inhaled steroids.
    Does anyone have information regarding these two issues?? I hate to change my regimen as it is so great to just breath without issues but do not like weight issues and bone loss down the line.

    August 17, 2010 at 18:14 | Report abuse | Reply
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