AANMA Clarifies FDA Asthma Medication Warnings

Allergy & Asthma Network Mothers of Asthmatics (AANMA) recently offered guidance to help patients understand recent Food and Drug Administration (FDA) warnings about Advair® (fluticasone and salmeterol), Foradil ® (formoterol), Serevent® (salmeterol) and Symbicort® (budesonide and formoterol), daily inhaled medications containing a long-acting beta agonist (LABA, a 12-hour bronchodilator).

FDA had two basic messages on Feb. 18:

  1. Asthma patients should not use inhaled 12-hour bronchodilators containing long-acting beta agonist alone; they should be used with an inhaled corticosteroid (ICS) to treat underlying inflammation.
  2. Patients should only use these medications under frequent medical supervision for symptoms that cannot be controlled with an ICS alone.

Bronchodilators relax the smooth muscles of the airways. They treat the noisy part of asthma: coughing, wheezing, and shortness of breath.

Foradil (formoterol) labeling says "significant bronchodilation" begins within 15 minutes whereas Serevent (salmeterol) starts quieting symptoms after about 30 minutes. All four reach their peak effectiveness at about 3 hours and provide up to 12 hours of symptom relief.

However, under no circumstances should any of these medications be used more frequently than every 12 hours. If symptoms develop, patients should use a quick-relief bronchodilator such as ProAir ®, Proventil ®, Ventolin ® or Xopenex ®, and notify their medical care provider.

Advair and Symbicort contain two medications: a long-acting beta agonist and an inhaled corticosteroid, a medication that treats the underlying part of asthma called airway inflammation. Serevent and Foradil contain only the long-acting beta agonist.

Daily use of any quick-relief or long-acting bronchodilator without medical supervision and monitoring can cause the patient to miss critical signs of progressively worsening airway inflammation. And therein lies the risk. FDA is concerned that by the time the patient realizes that the situation is serious, it could be too late.

"The key for asthma care is gaining and maintaining control of the asthma," said Stuart Stoloff, MD, a member of the NIH Expert Panel 3 that updated the NIH Guidelines for the Diagnosis and Management of Asthma in 2007 and chairman of AANMA's Board of Directors. "This requires open and ongoing communication between patients and healthcare providers, including regularly scheduled well visits to monitor levels of control and follow-up visits when medications are changed."

He added, "Patients who need to use their quick-relief inhaler more than twice a week on a regular basis unrelated to preventing exercise-induced bronchospasm need to speak with their healthcare provider, since their asthma is not well controlled."

"No one with asthma should need to use a long- or short-acting bronchodilator every day for the rest of their lives if they have addressed the underlying cause of symptoms," said Nancy Sander, founder and president of AANMA. "Getting and keeping asthma under control requires a strategic plan and a clear understanding of the role of allergies, reflux disease, sinusitis or other contributing factors."

Asthma is a serious, potentially life-threatening condition that claims the lives of more than 10 people each day. Medications are only one part of the course of treatment. Proper diagnosis, testing, a written asthma action plan, identification and avoidance of relevant allergens, eating healthy foods, daily exercise, and consultation with an allergist or other relevant specialists is the fastest way to resolve respiratory symptoms for the long-term future.

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