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FDA Approves Advair for Children Under 12

Inhaled Asthma Drug Shown to Be Effective in Young Children
WebMD Health News

April 22, 2004 -- The FDA has approved the first dual-action asthma drug for use in young children. The agency approved Advair for the treatment of asthma in children 4 to 11 years old with asthma that isn't adequately controlled by inhaled corticosteroid therapy alone.

Advair contains two different drugs. One, an inhaled corticosteroid, helps to prevent inflammation in the airways, and the other, a long-acting beta2-agonist, helps prevent the muscles surrounding the airways from tightening.

Advair has been approved for treating asthma in adults and children over age 12 since 2001.

Asthma Drug Approved for Young Children

The FDA based its approval on the results of a 12-week study of 203 children with asthma, ranging in age from 4 to 11 years old. The children still had asthma symptoms while being treated with low doses of an inhaled corticosteroid. The study compared the safety of treating the children with Advair twice daily vs. the inhaled corticosteroid alone twice daily.

Researchers found that treatment with Advair improved lung function on asthma breathing tests.

The study also showed that the two treatments had a similar safety profile.

Researchers caution that Advair does not replace fast-acting inhalers for sudden asthma attacks and should not be taken more than twice a day.

Side effects of Advair include a reduced ability to fight off infection while switching from an oral steroid to the inhaled steroid in Advair, high blood pressure, increased heart rate, and changes in heart rhythm.

Advair is made by GlaxoSmithKline, a WebMD sponsor.

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