FDA advisers: Certain drugs too risky to treat asthma in children

December 15, 2008

FDA advisers stated that two single-agent long-acting beta2 agonist inhalers should have their pediatric asthma indications discontinued, reported Reuters.

FDA advisers stated that two single-agent long-acting beta2 agonist inhalers should have their pediatric asthma indications discontinued, reported Reuters.

According to the panel, the two drugs - salmeterol and formoterol-carry high risks for asthma - related complications and death that are not outweighed by a relatively small apparent health benefit when the drugs are used without a steroid.

The majority of the panel voted against the age 12 to 17 indication, and voted unanimously against the age 4 to 11 indication, for both salmeterol and formoterol.

As the FDA will consider the recommendations and make an official announcement regarding their use and indications, agency officials stated that patients should not stop taking any prescribed asthma medications without consulting a physician.