Saturday, February 20, 2010

FDA Issues Warning on 4 Asthma Drugs

FDA issues warning on 4 common asthma drugs -

The US government is taking steps to curb use of some long-acting asthma drugs taken by millions, issuing safety restrictions to lower an uncommon but potentially life-threatening risk that asthma could worsen, suddenly.

The Food and Drug Administration's warnings cover the drugs Advair, Symbicort, Foradil and Serevent. The FDA said they should be used only by asthmatics who can't control their lung disease with other medications — and then only for the shortest time possible.

"Our goal is to overall reduce the use of LABAs, to manage the risk while at the same time keeping them available for those patients who really need them," said Jenkins, a pulmonologist.

"The reality is the available options to treat asthma are not that great," he added. For patients not well-controlled by inhaled corticosteroids alone, "their options for additional therapy are, in and of themselves, drugs with a lot of risk."

Other warnings:

• Children and teens should be prescribed only the combination LABA drugs to ensure compliance with both medications. That mostly happens today, as pediatric use of the single-agent drugs has plummeted with publicity about the risk.

• Manufacturers also will be required to study whether combination LABA use indeed lowers the risk.

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