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Foradil: Foradil Aerolizer
built 657 days ago
SAN FRANCISCO, CA -- May 23, 2001 -- Foradil® Aerolizer™ (formoterol fumarate inhalation powder) reduced symptoms and improved disease management in children with persistent asthma uncontrolled by inhaled corticosteroids (ICS) alone. These results were presented at the 97th annual American Thoracic Society meeting here. Foradil Aerolizer was approved by the Food and Drug Administration in February 2001 and is now available by prescription.
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Foradil Aerolizer may worsen your breathing problems. Long-acting beta-adrenergic agonists, such as formoterol, the active ingredient in Foradil Aerolizer, may increase the chance of death from asthma problems in some people. The package insert (labeling) for Foradil Aerolizer has been revised to include a Medication Guide (FDA-approved patient information) which contains information about these risks (see FDA LABA information).
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Foradil Aerolizer belongs to a class of drugs known as long-acting beta 2-adrenergic agonists (LABA), which are long acting bronchodilator medicines. These medicines are believed to make asthma episodes more severe when they occur. In one asthma medication study, a number of people taking a LABA died from their asthma compared to people taking placebo.
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Do not use Foradil Aerolizer to relieve sudden asthma symptoms (sudden severe onset or worsening of wheezing, cough, chest tightness, and/or shortness of breath diagnosed by your health care provider as being due to asthma). Sudden asthma symptoms should be treated with an inhaled, short-acting bronchodilator. If you do not have an inhaled, short-acting bronchodilator, contact your health care provider to have one prescribed for you.
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Foradil Aerolizer (formoterol) is a prescription drug manufactured by Novartis that is used to treat Asthma. On March 15th 2006, the FDA requested that Novartis update their existing product label with a black box warning in response to a number of asthma-related deaths.
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In the one-year study, Foradil Aerolizer produced rapid bronchodilation within five minutes that was well maintained for 12 hours. In addition, Foradil Aerolizer reduced day and nighttime asthma symptoms, and the need for rescue medication. The overall incidence of adverse events was comparable to placebo.
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Foradil Aerolizer