Do 12-hour bronchodilators help or harm patients with asthma? They can help reduce asthma symptoms, but do they increase the risk that an episode will become severe? At a two-day public hearing last December, experts on three Food and Drug Administration (FDA) Advisory Panels met to weigh the products’ risks and benefits, something the FDA has been studying since 2005.
At issue are two single-ingredient medications: Serevent® Diskus® (salmeterol xinafoate inhalation powder) and Foradil® (formoterol fumarate inhalation powder); and three medications that combine a 12-hour bronchodilator with an inhaled corticosteroid: Advair Diskus® (fluticasone prioprionate and salmeterol inhalation powder), Advair® HFA (fluticasone propionate and salmeterol) Inhalation Aerosol, and Symbicort® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol.
Manufacturers stated their products are safe when used as prescribed. In previous years they worked with FDA on new labeling and conducted additional research. The December meeting was convened to examine the results.
AANMA Founder and President Nancy Sander testified in support of continued patient access to all forms of 12-hour bronchodilators. “When prescribed and used as part of a comprehensive treatment plan, 12-hour bronchodilators have given back to patients the ability to work, climb stairs, attend school, sleep through the night, and compete in sports – without symptoms – things most others take for granted,” said Sander. “Until policies are in place to ensure that all patients diagnosed with asthma receive care according to the National Asthma Education and Prevention Program (NAEPP) guidelines, we will continue to see avoidable distress and deaths due to asthma.”
Sander also called for clarity: “Labeling and advertising for medications containing 12-hour bronchodilators often refer to them as ‘controllers’ which, for many patients, implies that the medication will control sudden symptoms. They are told to use a ‘rescue’ medication if they have symptoms between doses of the ‘controller.’ However, the term ‘rescue’ implies that these medications should only be used when symptoms are severe enough to be life threatening – a belief than can have deadly consequences if patients let symptoms get out of control before using their medications.
After 2 days of testimony, the advisory panels recommended single-ingredient medications Foradil and Serevent no longer be used on a regular schedule as long-term control medication to treat asthma, but said the benefits of combination medications Advair and Symbicort outweighed their risks and that the medications should continue to be available.
The panel expressed concern about using the combination medications in children under 12 because there are not enough pediatric studies to accurately assess the benefits, but stopped short of recommending against them. Instead, it recommended stronger labeling and better patient education for children and parents.
AANMA Outreach Service Coordinator (OSC) and patient representative panel member Andrea Holka agreed with the recommendation: “I believe that the risk of death or hospitalization due to nontreatment of asthma symptoms exceeds any potential adverse effects of the combination medications. And I am pleased that advisory board members requested more data on bronchodilators and concise, direct labeling that would remove ambiguity about how to use the medications as intended.”
AANMA Board Chairman-Elect Stuart Stoloff, MD, said, “The determination of safety of any medication is based on the risk/benefit ratio that should be discussed between the physician/clinician and the patient. The FDA is now reviewing labeling changes for all 12-hour bronchodilators with respect to their use in asthma.”
We’ll keep you posted as more information becomes available. Be sure to check out Nancy Sander’s blog at www.breatherville.org/ for the latest news.
Do you use a 12-hour bronchodilator? What’s your experience? How do you feel about the FDA review – should the medications stay or should they go? Let us know: editor@aanma.org.
Related posts:
- Talk to your healthcare provider about FDA 12-hour bronchodilator warnings
- AANMA Provides Straight Answers to FDA’s Announcement about Asthma Medications
- FDA Confirms New Label Language for Medications Containing Long-Acting Beta Agonists (LABAs)
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