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Expert calls ruling on asthma drugs “reasonable”
Dec 15, 08 Clinical UpdatesA Food and Drug Administration advisory panel ruled late Thursday that the risks of two asthma drugs—Serevent and Foradil—outweigh the benefits in children and adults with asthma.
The panel also ruled that two more commonly prescribed asthma drugs - Advair and Symbicort—have acceptable safety profiles for adults and children with asthma.
What makes these drugs different? Serevent and Foradil contain only a so-called “long-acting beta agonist” or LABA, while Advair and Symbicort contain both a LABA and an inhaled steroid.
It appears from the data, the FDA panel concluded, that LABAs should only be used in combination with an inhaled steroid.
“I think the decisions made are reasonable, in line with current evidence, and good for patients,” Dr. Thomas B. Casale, executive vice president of the American Academy of Allergy, Asthma & Immunology (AAAAI) told Reuters Health following the ruling.
“The use of LABAs in conjunction with inhaled corticosteroids benefits many patients with asthma and is an important option in our treatment armamentarium for this common disease,” added Casale, who is chief of allergy and immunology at Creighton University, Omaha, Nebraska.
In a written statement, the AAAAI notes that reports on potentially serious risks from using LABAs have raised awareness of these asthma drugs and has generated some confusion among patients and their families.
“Our advice,” Casale said, “would be to consult with your health care provider before making any changes in your asthma medications. If patients are treated according to the NIH guidelines they should be managed in line with the FDA panel recommendations.”
“That is, if they are using a LABA it should be in conjunction with an inhaled corticosteroid,” Casale said. “Although a risk was raised by the (FDA advisory) panel for LABAs, the incidence is low and patients should seek advice and guidance from their health care provider and not make any changes in their medication regimen on their own.”
There are two primary forms of treatment for asthma. “Controller” medications, such as inhaled steroids, reduce airway inflammation, and “reliever” medications, such as short-acting beta agonists (often called bronchodilators), relieve airway constriction.
For many asthma patients, a daily treatment plan combining inhaled steroids with LABAs is recommended to control asthma symptoms and prevent life-threatening attacks.
According to the AAAAI, the majority of studies have shown that the addition of LABAs to inhaled steroids yields better asthma control than the use of higher doses of inhaled steroids used alone. In fact, as the use of LABA inhalers has increased, the rate of asthma-related deaths has decreased, the AAAAI points out.
NEW YORK (Reuters Health)
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