Safety Alerts & Recalls

What does this mean?

This safety concern of an increased risk of severe exacerbation of asthma symptoms with LABAs has been known for some time and these products already contain a Black Box Warning relating to this risk. The updated prescribing information is intended to promote the safe use of LABAs in the treatment of asthma. Although the FDA first announced the labeling changes and recommendations to patients in February 2010, please review the recommendations and discuss any concerns with your doctor if you have asthma and use a LABA (sold as Serevent, Foravent, Perforomist and Brovana) or a LABA in combination with an inhaled corticosteroid (sold as Advair and Symbicort).

Updated Prescribing Information Now Available for Inhalers Used for Asthma: Serevent, Foradil, Brovana, and Others

The U.S. Food and Drug Administration (FDA) announced that Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have updated prescribing information. In February 2010, the FDA required manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms in adults and children that could lead to hospitalizations or death. Currently available LABAs include salmeterol (Serevent), formoterol (Foradil, Perforomist), and arformoterol (Brovana) as well as LABAs combined with an inhaled corticosteroid in a single inhaler, sold under the names Advair (salmeterol and fluticasone) and Symbicort (formoterol and budesonide).

The new recommendations in the updated prescibing information state: 1) 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. Examples of inhaled corticosteroids include beclomethasone (Beclovent, QVAR), budesonide (Pulmicort Flexhaler, Pulmicort Respules), ciclesonide (Alvesco), flunisolide (AeroBid, Aerospan), fluticasone (Flovent), mometasone (Asmanex Twisthaler), and triamcinolone (Azmacort).

2) LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

3) 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.

4) Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (for example: 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.

5) 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.

The new recommendations do not apply to the use of LABAs for the treatment of COPD.

For more information about the recent FDA MedWatch Alert, please visit: more information here

To view the February 2010 iGuard Safety Alert about this issue, please visit: more information here

Source: FDA
Publication Date: 2010-06-03
Last Updated: 2010-06-03
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