WASHINGTON — The government is taking steps to curb use of some long-acting asthma drugs taken by millions, issuing safety restrictions Thursday 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.
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.
Why? 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 Gerald Dal Pan.
It's hard to translate how big a risk that really is to the average person, but "it's probably not going to be a major problem," said Thomas Casale of the American Academy of Allergy, Asthma & Immunology.
Still, "there was a tendency to overuse" these medications, Casale added, saying too many doctors prescribed Advair or its relatives before trying standard treatment.