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The FDA announces warning on LABA medications used to treat asthma

The U.S. Food and Drug Administration announced that while long-acting beta agonists drugs (LABAs) used in the treatment of asthma are important in helping asthma patients, they should never be used alone. Clinical trials were conducted and show that using the long-acting medicines “is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma.”

Manufacturers will not only be required to take steps to reduce the overall use of these medications, but the FDA will now require that product labels of these drugs reflect the following:

  • The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone;
  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
  • LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
  • Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

Medications involved:

- Single agent products: Serevent and Foradil
- Combination medications: Advair and Symbicort that also contain inhaled corticosteroids.

Badrul Chowdhury, M.D., Director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research, says “Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death.”

Dianne Murphy, M.D., Director of the FDA’s Office of Pediatric Therapeutics stated, “The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone.”

Note: The new recommendations only apply to the use of LABAs in the treatment of asthma (not COPD) and the FDA is requiring manufacturers of LABAs to conduct additional studies to evaluate the safety of LABAs when used in combination with inhaled corticosteroids. Further, the FDA will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices.

If you or your child are using LABAs only to treat your/their asthma, contact your physician.

Need to find an allergist in the San Fernando Valley? Check out these two sites to begin your search:

Allergists in the San Fernando Valley (type in your address)
http://allergyandasthmarelief.org/locator_frame.html

The Allergy and Asthma Institute of the Valley
http://www.allergyandasthmainstitute.com/aboutus.asp

MORE INFO:
Long-Acting Beta Agonist (LABA) Information
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm

Safe Use Initiative
http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm

Consumer Inquiries: 888-INFO-FDA

 

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