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The FDA said Thursday it was taking a somewhat stronger step. People with other lung diseases, such as chronic obstructive pulmonary disease or COPD, use the drugs without the asthma risk, and just saying they shouldn't be used for asthma would have little practical effect, said Dr. John Jenkins, FDA's director of new drugs. So FDA labeled LABA-containing medications as contraindicated without simultaneous use of a different asthma-controlling medication -- a legal term with more enforcement muscle to limit prescription. FDA will monitor that, to see if doctors follow the rules.
"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."
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.
Advair and Serevent are marketed by GlaxoSmithKline, Foradil by Novartis AG and Symbicort by AstraZeneca.
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