New labeling for inhalers warns of death risk

March 13, 2006

Findings from a study of 26,000 patients, showing that long-acting beta 2-adrenergic agonist salmeterol may increase the risk of asthma-related death, has led to revised labeling for GlaxoSmithKline's Serevent Diskus and Advair Diskus. The new prescribing information states that salmeterol is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting beta-agonists or for patients whose asthma can be successfully controlled with low- to medium-dose inhaled corticosteroids or other controller medications along with occasional use of inhaled short-acting beta 2-agonists.

New labeling for inhalers warns of death risk

Findings from a study of 26,000 patients, showing that long-acting beta 2-adrenergic agonist salmeterol may increase the risk of asthma-related death, has led to revised labeling for GlaxoSmithKline's Serevent Diskus and Advair Diskus. The new prescribing information states that salmeterol is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting beta-agonists or for patients whose asthma can be successfully controlled with low- to medium-dose inhaled corticosteroids or other controller medications along with occasional use of inhaled short-acting beta 2-agonists. An updated black box warning cautions that salmeterol may increase the risk of asthma-related death. In addition, FDA-approved medication guides must now be dispensed to patients when prescriptions are filled for either inhaler.

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