Asthma patients should not take inhalable long-acting beta-agonists such as Advair, Symbicort, Serevent and Foradil unless they are also taking inhalable steroids, the Food and Drug Administration warned Thursday. Most patients are already taking both types of drugs together, but the FDA fears that those who take only the one drug have an increased risk of hospitalization and death. The FDA will require drug manufacturers to conduct new studies to explore the safety of the drugs when used in conjunction with inhalable steroids.
The warnings are part of a new safe-use initiative by the agency. The drug labels will be changed to reflect the warning, and physicians will be asked to educate patients about the change.
The warning does not apply to those who take the drugs, commonly called LABAs, for treating chronic obstructive pulmonary disease.
Advair and Symbicort are both combination drugs that include corticosteroids, but the FDA said inhalable steroids should be used even with them. The LABAs relax muscles in the lung's airways, improving a patient's ability to breathe freely and reducing asthma symptoms. Inhalable steroids are the primary medication used to control asthma, and the LABAs are used when the condition cannot be controlled with steroids alone. LABAs do not affect sudden-onset symptoms.
The new warning is based on a meta-analysis of clinical trials that shows that the drugs, used alone, increase the risk of adverse events, including death. The agency said there is not enough information available to determine if there is a risk when they are used in conjunction with inhalable steroids.
The agency's recommendations include:
-- The drugs should only be used in conjunction with an inhalable corticosteroid.
-- The drugs should be used long-term only in patients whose asthma cannot be adequately controlled on steroids alone.
-- LABAs should be used only for the shortest period of time required to achieve control of asthma symptoms and then discontinued.
-- Children should use a combination product such as Advair or Symbicort to ensure that they receive both classes of drugs.
[Updated 1 p.m.: A previous version of this post stated that the FDA recommended that children should use a combination product in conjunction with an inhalable steroid. The recommendation was that children should use a combination product such as Advair or Symbicort to ensure that they receive both classes of drugs.]
"The risks of hospitalization and poor outcomes are of particular concern for children," Dr. Diane Murphy, director of the FDA's Office of Pediatric Therapeutics said in a statement. "Parents need to know that their child with asthma should not be on a LABA alone."
-- Thomas H. Maugh II