From Medscape Medical News
By Robert Lowes
February 18, 2010 — The US Food and Drug Administration (FDA) announced today that manufacturers of long-acting beta agonists (LABAs) must now state on product labels that asthma patients must not take LABAs on a long-term basis unless their condition cannot be adequately controlled with other medications such as inhaled corticosteroids.
The labels also must state that the LABAs should never be used alone in the treatment of asthma in adults or children.
Roughly 95% of asthma patients using an LABA receive it in combination with a corticosteroid in a single inhaled product such as Advair Diskus, Advair HFA, or Symbicort, according to the FDA.
As a result of the new warnings labels required by the agency, patients who gain control of their asthma through these combination corticosteroid products need to be switched to a corticosteriod alone or some other "controller" medication, with no LABA added.
Recent analyses of clinical trials show that LABAs are associated with a higher risk of severe worsening of asthma symptoms, resulting in hospitalization, intubation, and sometimes death for adults and children alike, according to the FDA.
"We think the greater public health benefit is to reduce the use of LABAs, but keep them available for patients who really need them," said John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research at a news conference today. "There is still a benefit to these drugs for patients who aren't absolutely controlled on asthma-control medications."
More information is available on the FDA Web site.
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