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AstraZeneca Comments on FDA Joint Advisory Committee Meeting on Post-Marketing Safety Studies for the Use of LABAs in Asthma
Date:3/11/2010

ong-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 may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT (see WARNINGS in full Prescribing Information).

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who are receiving SYMBICORT should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.

Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known potent CYP3A4 inhibitors.


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