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FDA Updates U.S. Product Labels for LABA-Containing Medications Including AstraZeneca's SYMBICORT
Date:6/2/2010

ntinue 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."

In SYMBICORT clinical studies, AstraZeneca has shown that the combination of budesonide and formoterol  provides clear benefits to appropriate patients with asthma, such as improvement in asthma measures of control and quality of life.

Patients who are currently taking SYMBICORT should continue their prescribed medication, and talk to their doctor regarding any questions they may have about their treatment.

The updated label only impacts the asthma in
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SOURCE AstraZeneca
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