The Medical Letter on Drugs and Therapeutics
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1334
In Brief: Stopping Long-Acting Beta-2 Agonists
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Med Lett Drugs Ther. 2010 Mar 22;52(1334):21
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 Select a term to see related articles  2010   Advair   Advair Diskus   Advair HFA   Advair Inhalation Aerosol   Asthma   beta-2 agonists   Beta-2 agonists for asthma   beta2 agonists   Budesonide   Budesonide/formoterol   corticosteroids   Corticosteroids inhaled   Death with long-acting beta-2 agonists   Death with long-acting beta2 agonists   Drugs for Asthma   Flovent diskus   flovent HFA   Fluticasone propionate   Fluticasone/salmeterol   Foradil   Formoterol   In brief   In Brief: Stopping Long-Acting Beta-2 Agonists   inhaled   inhaled corticosteroids   Inhaled corticosteroids for asthma   inhaler   inhalers   Issue 1334   LABA   Long-acting beta-2 agonist   Long-acting beta2 agonists   March 22   Oxeze   page 21   Pulmicort   Pulmicort Flexhaler   Pulmicort Turbuhaler   Risk of death with long-acting beta-2 agonists   Risk of death with long-acting beta2 agonists   Salmeterol   Serevent   Stopping Long-Acting Beta-2 Agonists   Symbicort   Symbicort HFA   Symbicort Turbuhaler   volume 52 

A little more than a year ago, The Medical Letter reported the results of an FDA meta-analysis which found that use of a long-acting beta-2 agonist (LABA) such as salmeterol (Severent) or formoterol (Foradil) in patients with asthma was associated with an increased risk of a composite endpoint of asthma-related death, intubation or hospitalization; the highest risk was in children 4-11 years old.There was no significant increase in risk when a long-acting beta-2 agonist was used with an inhaled corticosteroid.The Medical Letter recommended that long-acting beta-2 agonists should not be used as monotherapy for asthma, especially in children, and that long-acting beta-2 agonists should be used for asthma only in combination with an inhaled corticosteroid, preferably in a fixed-dose combination in the same inhaler.1

Now the FDA has issued new Safe Use Requirements2 and labeling requirements for long-acting beta-2 agonists that include the following: “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

It has not been determined that patients taking a long-acting beta-2 agonist in a fixed-dose combination with an inhaled corticosteroid have an increased risk of death or that stopping long-acting beta-2 agonists in such patients will improve long-term outcomes. A controlled clinical trial of these new requirements would be welcome.

1. Long-acting beta-2 agonists in asthma. Med Lett Drugs Ther 2009; 51:1.

2. www.fda.gov/safety/medwatch/default.htm

3. BA Chowdhury and G Dal Pan. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. N Engl J Med 2010; Feb 24 (epub).

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