New FDA Recommendations for Discontinuation of LABAs

March 2, 2010 (New Orleans, Louisiana) — The recent safety mandates from the US Food and Drug Administration (FDA) on the use of long-acting beta agonists (LABAs) should be viewed with extreme caution, according experts speaking at a press briefing here at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2010 Annual Meeting.

Last week, the FDA announced that manufacturers of LABAs must now state on product labels that asthma patients should not take these drugs on a long-term basis unless their condition cannot be adequately controlled with other medications such as inhaled corticosteroids.

"Some of the recommendations from the FDA are areas where we need to take added consideration, but there are other areas that are going to create confusion among physicians, and maybe even more so among patients," William W. Busse, MD, professor and chair of the Department of Medicine at the University of Wisconsin School of Medicine and Public Health in Madison, told press and meeting attendees.

Dr. Busse was also chair of the third expert panel, which developed the National Asthma Education and Prevention Program (NAEPP)'s Guidelines for the Diagnosis and Management of Asthma, published in 2007.

"When we created the NAEPP report, we considered the issue of [LABAs] very seriously," said Dr. Busse, noting that everyone is in "total agreement" that LABAs should not be the sole therapy for anyone with persistent asthma.

However, he is concerned with the FDA's recommendation that after asthma control has been achieved with a combination of LABAs and inhaled corticosteroids, LABA use should be stopped as soon as possible.

"Although we spent considerable time in our guidelines talking about step-up therapy, as there are data available supporting this, the step-down process is not well worked out," he explained. "Suddenly stopping medication that is providing a protection for individuals — without good literature experience to back it up — is something we're very concerned about. Their recommendations really run counter to our guidelines."

In addition, Dr. Busse said that the combination therapy has been very effective, showing decreased morbidity, hospitalizations, and exacerbations. "The indices of safety that have been raised [by the FDA] really do not appear in the literature, and we really need to see new data before making dramatic changes in our recommendations."

"As a practicing physician, combination therapy has changed how effective I can be in caring for my patients with asthma," he added. "I feel that control is improved and that they have a more stable disease."

Dr. Robert Lemanske

"Asthma isn't a single disease and limiting our choices of interventions takes away the effectiveness of our treatment of both adults and children," agreed Robert F. Lemanske Jr, MD, professor and head of the Division of Pediatric Allergy, Immunology, and Rheumatology at the University of Wisconsin, who was also a member of the third expert panel.

He added that there's a concern about high and medium doses of inhaled corticosteroids on long-term growth in children. "As a clinician, anything I can do to limit that dose is a very important end point."

Stanley J. Szefler, MD, head of pediatric clinical pharmacology at National Jewish Health in Denver, Colorado, and another member of the third expert panel, said that he's concerned that clinicians will think that once they achieve asthma control, they should consider stepping down right away instead of continuing to monitor the condition. "We know that patients who had an exacerbation in the previous year are at risk for an exacerbation in the coming year."

"We think that we can avoid some of the FDA's concerns by continuing our efforts in educating patients to alert physicians when they feel that they are losing control," he explained. "Clinicians should also be prepared to answer questions from patients to keep them from just stopping their medications because of concerns regarding the FDA's statements."

Dr. Lemanske said that the bottom line is that although everyone agrees that LABAs should not be used as monotherapy, "we don't necessarily think that anything else needs to be changed right now. We would also really like to have data for the FDA's recommendations, because our guidelines were based on the best data available, and that hasn't changed since they were published."

Immediate past president of the AAAAI, Paul A. Greenberger, MD, professor of medicine in the Division of Allergy/Immunology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois, said that the Academy has several concerns with the FDA's recommendations, including a disagreement on how much weight should be assigned to the studies cited. "The information from those studies as to how the patients were treated is different from the Expert Panel Report and other documents that are currently recognized."

In addition, the AAAAI "does not want to see insurers or pharmacy benefit managers erecting more barriers because of this recommendation that will result in patients going out of control or becoming unstable before a physician or healthcare provider can continue their medication," concluded Dr. Greenberger.

American Academy of Allergy, Asthma and Immunology (AAAAI) 2010 Annual Meeting. Presented March 1, 2010.

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