The Food and Drug Administration on Thursday called for putting new limits on powerful and long-lasting bronchial drugs that millions of Americans use to treat asthma -- a move designed to lower the risk of complications leading to hospitalization or even death.
Physicians were urged to switch asthma patients away from medicines containing both long-acting beta agonists, commonly called LABAs, and inhaled corticosteroids.
Instead, the FDA said, patients should use products containing only the corticosteroids or other asthma-relieving medication whenever possible.
In addition, patients who cannot control asthma symptoms any other way should use LABAs for the shortest possible time, but the drugs should never be used alone in treating asthma in adults or children, the agency said.
About 95% of LABA users receive the drug through a combination product, according to the agency.
The drugs affected by the FDA action include the LABA-only products Serevent and Foradil, along with Advair and Symbicort, which contain both LABAs and inhaled corticosteroids. All are dispensed in inhalers via prescription.
Manufacturers will be required to include new warnings on the drugs' labels, educate patients and physicians about risks associated with the use of LABAs and study whether using the long-acting compounds in tandem with other drugs makes them safer.
Friday, February 19, 2010
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