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FDA Advisory

FDA issues warning on Advair, Symbicort, Foradil and Serevent

The Food and Drug Administration has issued warnings on 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.

The FDA 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.

Nor should LABA-containing drugs ever be used without simultaneous use of a different asthma-controlling medication, such as an inhaled corticosteroid — a move that specifically targets two of the drugs, Foradil and Serevent, the FDA said.

These four drugs contain an ingredient that relaxes muscles around stressed airways, called a long-acting beta agonist or LABA. While they’re very helpful at preventing day-to-day symptoms for some patients, the way LABA-containing drugs work also sometimes masks that inflammation is building in the airways. That means patients may not realize a serious asthma attack is brewing until they’re gasping for air.

The FDA cited studies that showed an increased risk of hospitalization and even some deaths, particularly among children. One study found three extra adverse events — mostly hospitalizations — for every thousand patients who took a LABA-containing drug compared to another asthma medication, said FDA’s Dr. Gerald Dal Pan.

FDA’s advice that patients quit the LABA-containing drugs as soon as their asthma is under control and go back to standard medications such as inhaled corticosteroids for day-to-day maintenance.

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.

Advair and Serevent are marketed by GlaxoSmithKline, Foradil by Novartis AG and Symbicort by AstraZeneca.