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Ask the Expert - Asthma, Advair and the FDA Black Box Warning (March 2011)

Question

A 26 year old African American female with a history of asthma since childhood came into our office for evaluation of her asthma.  She denies a smoking history and has not been hospitalized or visited the emergency room during the past 12 months. She is currently taking Advair 250/50 bid and uses albuterol as needed.  She stated that since she was prescribed the Advair she has not needed to use her albuterol inhaler daily, but does take 2 puffs prior to working out or participating in a physical activity.  She is aware of the FDA black box warning and is concerned for her safety using the medication, but is very reluctant to change.  

Should the patient be stepped down from her medication since she has been stable?  What recommendations do you suggest for approaching the issue of the FDA “black box” warning since she is reluctant to change her medication and dosage?  

Answer

The clinician may choose to discuss the very small risk of asthma-related deaths in patients taking long acting beta agonists.  In a large surveillance study (known as the SMART study), many of these unfortunate events seemed to have occurred in patients using only long acting beta agonists without inhaled steroids and more frequently in African American patients.  For this reason, asthmatic patients should never be treated with long-term LABA agents without an ICS. It is generally believed the risk of severe exacerbations and death may not apply to patients taking an inhaled steroid- long acting beta agonist combination drugs.  This is not proven, however, and further studies are being conducted to determine if the same risks exists for patients receiving ICS-LABA combination agents.  This patient has been well controlled on a medium dose ICS-LABA agent. According to the FDA issued black box warning, it is appropriate to recommend to the patient a trial of discontinuation of the LABA to see if she can be controlled adequately an ICS agent alone. If the patient refuses to follow this recommendation, it is a good idea to document in the patient’s chart that she was informed of the potential risk of LABA therapy but declined a trial of monotherapy with an ICS.

 

 
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