LYCOS RETRIEVER 
Foradil: Asthma
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Foradil relaxes the muscles in the walls of the airways, allowing them to expand. Taken on a twice-daily basis, it helps to control asthma in people who need regular treatment with short-acting inhalers, including people with nighttime asthma. Regular twice-daily use can ... relieve tightening of the airways in people with Chronic Obstructive Pulmonary Disease, including chronic bronchitis and emphysema.
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Foradil must not be used to relieve acute asthma symptoms. In the event of an acute attack, a short-acting beta2-agonist should be used. Patients must be informed of the need to seek medical treatment immediately if their asthma deteriorates suddenly.
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The panel was asked to review the safety of GlaxoSmithKline’s Serevent and Advair and Novartis’ Foradil. The agency received reports of life-threatening respiratory problems and deaths in Serevent users within the first six months of its approval in 1994. In a post- marketing study of Serevent and the final phase of Foradil’s pre-approval studies, a small number of patients experienced severe exacerbations of their asthma.
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Clinical studies with Foradil suggested a higher incidence of serious asthma exacerbations in patients who received Foradil than in those who received placebo (see Adverse Effects). These studies do not allow precise quantification of the differences in serious asthma exacerbation rates between treatment groups.
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