Sunday, February 21, 2010

Update on Long Acting Bronchodilating Agents

On 2/18/10, the FDA changed how it recommended long acting bronchodilating agents (LABAs) are use to treat asthma.  The announcement is here and below is the summary from that page.  
  • The use of LABAs is contraindicated without the use of an asthma controller medication such as an inhaled corticosteroid. Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
  • LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
  • Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.
Based on the available information, FDA concludes there is an increased risk for severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma. The agency is requiring the REMS and class-labeling changes to improve the safe use of these products.

First, will this change my practice?  Note roughly 95% of asthma patients using an LABA receive it in combination with a corticosteroid in a single inhaled product such as Advair Diskus, Advair HFA, or Symbicort, according to the FDA.  Yes, over 90% of my patients with asthma are currently being treated with a combination corticosteroid + LABA product.  I already follow the National Heart, Lung, Blood Institute's 2007 Guidelines where once the patient is at their personal best of spirometry and clinically and has been stable for 6 months, then I try to step down their controller meds slowly.  This is bullet point 3 above, so this only reinforces my current approach.  Overall, I don't see much change occurring.  The FDA calls for additional studies.  I agree with this also.
That's where the Allergy Dude stands with this FDA announcement.

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