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FDA Confirms New Label Language for Medications Containing Long-Acting Beta Agonists (LABAs)

On June 3, 2010 @ 4:35 pm In All Articles,Medications

“With today’s news, we are able to reassure patients of the safety of these medications when used according to newly clarified label instructions – which are consistent with NIH Asthma Guidelines.” – Carol Jones, RN, AE-C

Today FDA confirmed new safety labeling language for inhaled medications containing long-acting beta agonists, otherwise known as LABAS, and by brand name: Serevent Diskus, Foradil Aerolizer, Foradil Certihaler, Advair Diskus, Advair HFA, Symbicort, Brovana and Perforomist. (See chart [1] below for more details about each medication.)

LABAs relax airway spasms associated with asthma and chronic obstructive pulmonary diseases (COPD) for up to 12 hours. The label changes apply specifically to their use in patients with asthma.

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.

AANMA’s president, Nancy Sander, and director of patient advocacy, Sandra Fusco-Walker, joined in on the conference call today in which FDA released the long-awaited statement.

Sander said: “We are pleased with the labeling recommendations, as they are consistent with NIH Asthma Guidelines [2] findings. They clarify the best way to safely use these medications. We do recommend, however, that FDA change the term ‘adequately controlled’ to ‘well-controlled’ for assessing the patient status when stepping therapy down to quick-relief bronchodilators such as albuterol or levalbuterol. A patient whose symptoms are adequately controlled is not necessarily stable, whereas a patient whose symptoms are well-controlled has been symptom-free for a significant period of time.

“In addition, we asked FDA to replace references to ‘rescue medicatons’ with ‘albuterol or levalabuterol’ or the term ‘quick-relief bronchodilators.’ The term ‘rescue’ implies use only in life-threatening episodes of asthma, when in reality this class of medications should be used at the first sign of symptoms so that an emergency situation does not arise. In addition, these medications are used prior to unavoidable exposures to known allergens or irritants, and in the case of albuterol, prior to exercise. There is no scientific evidence suggesting that albuterol or levalbuterol should be limited to a ‘rescue’ designation. FDA said they would take our comments into consideration.”

Carol Jones, RN, AE-C, was also on today’s call. She said: “We received numerous phone calls and e-mails from patients who were frightened to take their 12-hour bronchodilators while labeling concerns were being debated. With today’s news, we are able to reassure patients of the safety of these medications when used according to newly clarified label instructions – which are consistent with NIH Asthma Guidelines and the way we’ve been advising patients to use the medications. So bottom line: There were no surprises today, and that’s good news!”

Click here [3] to read FDA’s statement.

FDA-Approved Long-Acting Beta Agonists (LABAs):

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. 


Article printed from Allergy and Asthma Network Mothers of Asthmatics: http://www.aanma.org

URL to article: http://www.aanma.org/2010/06/fda-confirms-new-label-language-for-medications-containing-long-acting-beta-agonists-labas/

URLs in this post:

[1] chart: #Chart

[2] NIH Asthma Guidelines: http://www.nhlbi.nih.gov/guidelines/asthma/

[3] Click here: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm

[4] Press Release 20100223: http://www.aanma.org/press-room/press-releases/press-release-20100223/

[5] Medication Effectiveness: http://www.aanma.org/faqs/medications/effectiveness/

[6] Asthma Patients: Talk to Your Healthcare Provider About FDA 12-Hour Bronchodilator Warnings: http://www.aanma.org/press-room/press-releases/press-release-20100302/

[7] Noisy and Quiet Asthma Medications: http://www.aanma.org/2009/02/noisy-and-quiet-asthma-medications/

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