Drug Information Update - New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)

Drug Information Update – New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

Due to safety concerns, the U.S. Food and Drug Administration (FDA) is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) are used in the treatment of asthma. These changes are based on FDA’s analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.

LABAs are approved as single-ingredient products (Serevent and Foradil) and as an ingredient in combination products containing inhaled corticosteroids (Advair and Symbicort) for the treatment of asthma and chronic obstructive pulmonary disease (COPD). They work by relaxing muscles in the airway and lungs. This helps patients breath easier, and lessens symptoms such as wheezing and shortness of breath. The new recommendations only apply to the use of LABAs in the treatment of asthma.

For more information, please visit: LABAs
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm

FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
FDA Approved Medications Containing a Long-Acting Beta Agonist (LABA)
Data Summary

Safety Announcement
[02-18-2010] Due to safety concerns, the U.S. Food and Drug Administration (FDA) is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) are used in the treatment of asthma. These changes are based on FDA’s analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma (see Data Summary below).
LABAs are approved as single-ingredient products (Serevent and Foradil) and as an ingredient in combination products containing inhaled corticosteroids (Advair and Symbicort) for the treatment of asthma and chronic obstructive pulmonary disease (COPD). They work by relaxing muscles in the airway and lungs. This helps patients breath easier, and lessens symptoms such as wheezing and shortness of breath. The new recommendations only apply to the use of LABAs in the treatment of asthma.
To ensure the safe use of these products:
The use of LABAs is contraindicated without the use of an asthma controller medication such as an inhaled corticosteroid. Single-ingredient 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 the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.
FDA is also requiring a risk management program called a Risk Evaluation and Mitigation Strategy (REMS) for these products. The REMS for LABAs will include a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. In addition, FDA is requiring the manufacturers to conduct additional clinical trials to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. FDA will seek input on these studies at a public advisory committee meeting on March 10-11, 2010.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended above will improve the safe use of these drugs.
Additional Information for Patients
Long-Acting Beta Agonists (LABAs) do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden onset asthma symptoms.
LABAs must never be taken alone for the treatment of asthma.
Patients who need a LABA plus an asthma controller medication that is not available as a combination product should work with their healthcare professionals to ensure that each individual medication is taken correctly.
Patients should read the Medication Guide for LABAs.
Patients should talk with their healthcare professional to learn the warning signs of worsening asthma.
Patients should discuss any questions they have about the use of LABAs with their healthcare professional.
Additional Information for Healthcare Professionals
Long-Acting Beta Agonists (LABAs) should not be started in patients with acutely deteriorating asthma.
Discuss with patients and families the warning signs of worsening asthma and advise them to seek immediate medical attention should their condition deteriorate.
LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms.
Encourage patients, families, and caregivers to read the Medication Guide that accompanies LABA prescriptions.
When possible, prescribe a combination inhaled corticosteroid – LABA product to pediatric and adolescent patients who need the addition of a LABA for better control of their asthma. Using a combination product will help ensure compliance with both of these medications.