FDA's recommendations over LABAs: AANMA advises patients to make informed decisions

Mar 3 2010

Allergy & Asthma Network Mothers of Asthmatics (AANMA) encourages patients to make informed decisions about recent U.S. Food and Drug Administration (FDA) recommendations affecting patients using asthma medications known as long-acting beta agonists (LABAs) or 12-hour bronchodilators: Advair, Foradil, Serevent and Symbicort.

This was also the message presented by allergists speaking this week at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting in New Orleans. Allergists are concerned that FDA's recommendations are not consistent with Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR3) or with significant clinical practice in real-world settings. Furthermore, experts stated that FDA may have given more credence to some research that EPR3 authors considered unsupported by evidence.

"FDA's recommendations and public statements have serious implications for patients, particularly if patients using these medications suddenly decide to stop taking them because they don't know whose advice to follow," said Nancy Sander, AANMA president and founder. "Patients and families are advised to continue taking medication as prescribed and to avoid known allergens and irritants. Never use these medications more frequently than every 12 hours. Anyone using these medications on a daily basis should be in the care of an asthma specialist."

"The key for asthma care is gaining and maintaining control of the asthma," said Stuart Stoloff, MD, a member of the EPR3 panel 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."

Allergists at the AAAAI meeting said that safety data concerning 12-hour bronchodilators had been carefully reviewed when the EPR3 Guidelines update was developed in 2007 and that no new data published since warrants any change to the Guidelines recommendations.

The recommendations issued by FDA on February 18 covered two basic issues:

1.Asthma patients should not use inhaled 12-hour bronchodilators containing long-acting beta agonist (LABA) 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; and use of the medications should be discontinued once asthma symptoms are under control.

The physicians speaking at the AAAAI meeting said they agree that it's best to combine a LABA and an ICS, rather than using a LABA alone, and they said that these medications offer an important treatment option. "As a practicing physician, my experience is that combination medications [containing a 12-hour bronchodilator along with an inhaled corticosteroid in one dose] have changed how effective I've been able to be as a physician," said William Busse, MD, chairman of the NIH Expert Panel 3. "We don't see asthma patients being admitted into the hospital like before."

But this is where agreement with FDA's recommendation ends. Stanley Szefler, MD, also a member of Expert Panel 3, emphasized the importance of continuing to use a 12-hour bronchodilator if it's helping a patient manage symptoms. "It doesn't make sense to bring a patient to [a level of] good control and then stop what got them there," he said. "It's a lot like achieving good blood pressure, then stopping the medication. We are concerned that patients will achieve control and then stop the medication," which he said could lead to dangerous consequences which could include death.

Source Allergy & Asthma Network Mothers of Asthmatics