FDA Updates U.S. Product Labels for LABA-Containing Medications Including AstraZeneca's SYMBICORT

Thu, 06/03/2010 - 4:47am

The FDA has released final label revisions for respiratory medications that contain an active ingredient known as a long-acting beta-agonist (LABA). This follows the FDA communication on 18 February 2010 requesting all manufacturers of LABA-containing medications to undertake class-labeling changes.

The FDA made label revisions to both single ingredient and combination LABA-containing medications. For the treatment of asthma, single ingredient LABAs should only be used with an asthma controller medication such as an inhaled corticosteroid (ICS), they should not be used alone. SYMBICORT® (budesonide/formoterol fumarate dihydrate) is an asthma combination medication that contains both an ICS (budesonide) and a LABA (formoterol).

The updated label for combination asthma medications, including SYMBICORT, provides guidance on how these products should be prescribed to treat asthma, including:

-- SYMBICORT should only be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. -- Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g. discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid.

In addition, the Boxed Warning, and other relevant sections of the label, have been revised to inform healthcare professionals and patients that LABAs, when used as single ingredient products, increase the risk of asthma-related death based on a large placebo-controlled study with salmeterol (a single ingredient LABA product). FDA considers this risk to be a class effect of all LABAs, including formoterol, one of the components of SYMBICORT. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.

"AstraZeneca is confident in the positive benefit-risk profile of SYMBICORT in asthma. Combination therapies, such as SYMBICORT, continue to play a critical role in helping appropriate patients control asthma symptoms," said Dr. Cathy Bonuccelli, Vice President, Clinical Respiratory & Inflammation, AstraZeneca. "Regular assessments of patients' asthma control by their physicians is important for ensuring that they are on the appropriate therapy based on their individual treatment needs."




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