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

dication for SYMBICORT and does not pertain to the other approved use of SYMBICORT for chronic obstructive pulmonary disease (COPD).

To view the FDA communication, visit the following FDA Web site link: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm

Important Safety Information, including boxed WARNING

WARNING: ASTHMA RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as formoterol one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2- adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. 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. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, 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. On
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SOURCE AstraZeneca
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