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FDA and Safe Use of Long-Acting Beta-Agonists The FDA and Safe Use of Long-Acting Beta-Agonists
in the Treatment of Asthma
Badrul A. Chowdhury, M.D., Ph.D., and Gerald Dal Pan, M.D., M.H.S.
For over a decade, the Food concern about the risk among use of LABAs should be limited and Drug Administration children. Public discussions at to patients who require pro- (FDA) and the medical commu- FDA advisory committee meet- longed use of these drugs.
nity have discussed how to safely ings in 2005, 2007, and 2008 use long-acting beta-agonists (summarized at www.fda.gov), ing new authority under the FDA (LABAs) — drugs designed to as well as discussions in the Amendments Act (FDAAA) of provide bronchodilation for 12 Journal,2-4 reflect the varied in- 2007, the FDA implemented these hours or longer through stimu- terpretations of these data and updated recommendations by re- lation of the β2-adrenergic re- their implications for the safe quiring professional drug-label ceptor.1 Even before U.S. approv- use of LABAs.
The FDA has now conducted LABAs (see table).
concern about a paradoxical in- a comprehensive review of the crease in serious asthma exacer- benefits and risks of using LABAs these label changes. First, al- bations in some patients treated to treat asthma. The agency has though it is already common with these drugs. The Serevent concluded that the benefits of practice that a LABA not be used nationwide surveillance (SNS) LABAs continue to outweigh the without concurrent use of an study suggested an increased risks when the drugs are used asthma-controller medication, risk of asthma-related death in appropriately and that the agents the new contraindication em- patients treated with salmeterol should remain available for the phasizes the seriousness of the as compared with albuterol, a treatment of asthma. However, risk associated with LABA short-acting beta-agonist (SABA). because of their serious risks, the monotherapy. Second, the FDA Shortly after approving salmet- FDA recommends that LABAs be believes that the risks of LABAs erol in 1994, the FDA began to reserved for patients whose can be minimized if the agents receive reports of serious asth- asthma cannot be adequately are used judiciously and that pa- ma exacerbations and deaths in managed with asthma-controller tients who do not require long- patients treated with the drug. medication such as an inhaled term LABA therapy should not To further evaluate these re- corticosteroid. Furthermore, un- be exposed to the risk. Data ports, the manufacturer con- til additional data are available suggest that many patients are ducted the Salmeterol Multi- from large, randomized, con- administered the combination center Asthma Research Trial trolled trials evaluating the safe- products containing an inhaled (SMART), in which, over the ty of LABAs when administered cortico ste roid and a LABA with- course of 28 weeks, there were with an inhaled corticosteroid, out first undergoing stepwise eight more asthma-related deaths the FDA believes that long-term increases in treatment with an Specific Label Changes for Long-Acting Beta-Agonists (LABAs).
1. Contraindicate the use of LABAs for asthma in patients of all ages without con- comitant use of an asthma-controller medication such as an inhaled cortico- 2. Stop use of the LABA, if possible, once asthma control is achieved and maintain the use of an asthma-controller medication, such as an inhaled corticosteroid.
3. Recommend against LABA use in patients whose asthma is adequately con- trolled with a low- or medium-dose inhaled corticosteroid.
4. Recommend that a fixed-dose combination product containing a LABA and an inhaled corticosteroid be used to ensure compliance with concomitant therapy in pediatric and adolescent patients who require the addition of a LABA to an n engl j med 362;13 nejm.org april 1, 2010 Downloaded from www.nejm.org at UNIVERSITY OF KANSAS MEDICAL CENTER on April 8, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. FDA and Safe Use of Long-Acting Beta-Agonists inhaled corticosteroid alone. verse outcomes, the FDA believes other SABAs be used only as Third, long-term use of LABAs it is prudent to emphasize their needed for short-term symptom in patients with asthma should use and limit the long-term use relief and that asthma-controller be limited to those whose asth- of LABAs.
An important unanswered mize SABA use.5 Other than the asthma-controller medications. question about LABA use is duration of bronchodilatation, Finally, the FDA recommends whether concomitant use of an the basic pharmacologic activity the use of combination products inhaled corticosteroid mitigates and clinical effect of LABAs and containing an inhaled corticos- the risk of asthma-related death. SABAs are the same. The FDA teroid and a LABA in children The SNS study and SMART did therefore believes it is inconsis- and adolescents because of the not systematically test the effect tent to recommend long-term use difficulty of ensuring compli- of concomitant use and cannot of LABAs, particularly since LABAs ance with both medications answer this question. At the have also been shown to increase when they are administered sep- 2008 advisory committee meet- the risk of asthma-related death.
The FDA’s recommendation ses of controlled clinical trials eral actions to ensure that pre- that LABA use be discontinued if of LABAs used to treat asthma scribers and patients are aware possible after asthma control has were presented by the FDA and of the new recommendations for been achieved may cause conster- the LABA manufacturers. Some the safe use of LABAs. Under its nation among prescribers, since of the analyses suggested a de- Safe Use Initiative, the agency asthma treatment guidelines and creased risk of serious asthma- will work with public and pri- current practice focus on step- related adverse events in associ- vate health care groups to widely ping down the dose of inhaled ation with combination therapy disseminate information about corticosteroids in patients who as compared with a LABA alone, the new labeling. The FDA will require combination cortico ste- but other analyses did not. Giv- also work with these partners to roid and LABA therapy.5 The en the seriousness of the risks assess whether prescribing pat- guidelines recommending long- associated with LABA use and terns change, leading to the pre- term use of LABAs were partly the uncertainty about the role of scribing of LABAs only with influenced by studies showing a inhaled corticosteroids in miti- concomitant use of a controller benefit from adding a LABA to gating this risk, the FDA believes drug, compliance with the rec- an inhaled corticosteroid for the that long-term use of LABAs ommendation of dual LABA and long-term treatment of persis- should be limited to patients who inhaled-corticosteroid therapy, and tent asthma. These studies have truly need them.
instance, the benefits shown acerbations and asthma-related definitively determine whether the were largely a measure of the death is not unique to LABAs. It addition of LABAs to inhaled cor- beta-agonist effect, such as im- has been known for over 50 ticosteroids increases the risk of proved airflow and reduced res- years that SABAs can worsen serious asthma outcomes. Using cue use of SABAs. There are no asthma and cause asthma-relat- new authorities under FDAAA, studies showing that LABAs ed death. Although the mecha- the FDA will require manufactur- (alone or in conjunction with in- nisms by which beta-agonist ers of LABAs to conduct large haled corticosteroids) increase bronchodilators cause asthma- clinical trials that evaluate this survival or positively affect se- related death remain uncertain, risk by comparing inhaled corti- vere asthma exacerbations (those it is hypothesized that they may costeroids plus LABAs with in- necessitating intubation or hos- increase sensitivity to broncho- haled corticosteroids alone. The pital-based care). Given the clear constrictive stimuli or mask the agency will seek input into the benefits of inhaled corticoster- symptoms of worsening asthma. design of these studies at an open oids in patients with asthma To minimize this risk, current advisory committee meeting in and the fact that they have not asthma-treatment guidelines March 2010. Until such data are been associated with serious ad- recommend that albuterol and available, the FDA believes that n engl j med 362;13 nejm.org april 1, 2010 Downloaded from www.nejm.org at UNIVERSITY OF KANSAS MEDICAL CENTER on April 8, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved. FDA and Safe Use of Long-Acting Beta-Agonists the existing evidence supports This article (10.1056/NEJMp1002074) was the influence of values. N Engl J Med 2009; published on February 24, 2010, at NEJM.org.
360:1592-5.
4. Drazen JM, O’Byrne PM. Risks of long-
1. DailyMed. Professional drug-label infor-
acting beta-agonists in achieving asthma thors are found with the full text of this mation. Rockville, MD: National Library of control. N Engl J Med 2009;360:1671-2.
5. National
Prevention Program. Expert panel report 3: From the Division of Pulmonary and Allergy 2. Martinez FD. Safety of long-acting beta-
and the Office of Surveillance and Epidemi- agonists — an urgent need to clear the air. Heart, Lung, and Blood Institute, August ology (G.D.P.), Center for Drug Evaluation 3. Kramer JM. Balancing the benefits and
Copyright 2010 Massachusetts Medical Society. risks of inhaled long-acting beta-agonists — n engl j med 362;13 nejm.org april 1, 2010 Downloaded from www.nejm.org at UNIVERSITY OF KANSAS MEDICAL CENTER on April 8, 2010 . Copyright 2010 Massachusetts Medical Society. All rights reserved.

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