FDA mandates asthma drugs safety rules

WASHINGTON, Feb. 18 (UPI) -- The U.S. Food and Drug Administration says it has developed new safety rules for the use of specific drugs used to treat asthmatic patients.

The FDA said it has decided drugs in the class of long-acting beta agonists, called LABAs, should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include that warning on the drugs' labels, while taking other mandated steps to reduce the overall use of the medications.

Officials said the new rules are based on clinical trials showing use of the long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization and, in some cases, death.

The FDA said the drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids.

"Although these medicines play an important role in helping some patients control asthma symptoms, our review … determined their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death," said Dr. Badrul Chowdhury, director of the FDA's Division of Pulmonary and Allergy Products.

LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease, the FDA said, but the new rules only apply to the treatment of asthma.

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