FDA Drug Safety Communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)
Safety Announcement
Safety Announcement
[06/02/2010]Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma. The new recommendations do not apply to the use of LABAs for the treatment of COPD.
In February 2010, the agency announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma (see February 2010 LABA Drug Safety Communication1).
The new recommendations in the updated labels state:
Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.
FDA believes that when LABAs are used according to the recommendations outlined above and in the approved drug labels, the benefits of LABAs in improving asthma symptoms outweigh their risks of increasing severe asthma exacerbations and deaths from asthma.
Additional Information for Patients
Long-Acting Beta Agonists (LABAs) do not relieve sudden-onset asthma symptoms. You should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden onset asthma symptoms.
LABAs must never be taken alone for the treatment of asthma.
If you need a LABA plus a long-term asthma control medication that is not available as a combination product, you should work with your healthcare professional to ensure that each medication is taken correctly.
You should read the Medication Guide for LABAs and talk to your healthcare professional about any questions you may have about the use of LABAs.
Additional Information for Healthcare Professionals
Long-Acting Beta Agonists (LABAs) should not be started in patients with acutely deteriorating asthma.
Discuss with patients and families the warning signs of worsening asthma and advise them to seek immediate medical attention should their condition deteriorate.
LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms.
Encourage patients, families, and caregivers to read the Medication Guide that accompanies LABA prescriptions.
In pediatric and adolescent patients who need the addition of a LABA to an inhaled corticosteroid, prescribe a combination inhaled corticosteroid - LABA product. Using a combination product will help ensure adherence with both of these medications.
FDA Approved Long-Acting Beta Agonists
Brand Name LABA active ingredient Corticosteroid active ingredient FDA Approved Uses
Serevent Diskus Salmeterol None Asthma, COPD,
exercise-induced bronchospasm
Foradil Aerolizer Formoterol None Asthma, COPD, exercise-induced bronchospasm
Foradil Certihaler* Formoterol None Asthma
Advair Diskus Salmeterol Fluticasone Asthma, COPD
Advair HFA Salmeterol Fluticasone Asthma
Symbicort Formoterol Budesonide Asthma, COPD
Brovana Arformoterol None COPD
Perforomist Formoterol None COPD
* not currently marketed in the U.S.
-Related Information
Long-Acting Beta Agonist (LABA) Information2
Safety Information for Consumers and Healthcare Professionals
FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)3
2/15/2010
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