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Questions and Answers: New Safety Requirements for Long-Acting Asthma Medications called Long-Acting Beta Agonists (LABAs)

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On February 18, 2010 the Food and Drug Administration issued a drug safety communication titled: Questions and Answers: New Safety Requirements for Long-Acting Asthma Medications called Long-Acting Beta Agonists (LABAs)

I am Yolanda Fultz-Morris from F-D-A's Center for Drug Evaluation and Research.

Due to safety concerns, FDA is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists, or LABAs, are used in the treatment of asthma. These changes are based on FDA's analyses of studies showing an increased risk of severe worsening 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.

FDA staff developed some questions and answers to increase understanding about FDA actions taken and the need for this communication. Patrick Clarke, public affairs specialist, Division of Public Affairs, will be providing the responses.

Q1. What is FDA announcing today?

A. FDA is announcing its recommendations to change how long-acting inhaled medications, or LABAs, are used in the treatment of asthma. FDA is also requiring a risk management program called a risk evaluation and minimization strategy, or R-E-M-S, to help ensure the safe use of these products.

Q2. Why do people use LABAs?

A. LABAs are used to help people with asthma or a lung condition called chronic obstructive pulmonary disease, or C-O-P-D, breath easier. LABAs are also used for exercise-induced bronchospasm. LABAs are inhaled through the mouth into the lungs using an inhaler or nebulizer device and improve breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs. LABAs are available as single ingredient products, or in combination with a corticosteroid medication. For asthma, LABAs are available by prescription in dry powder inhalers or metered-dose inhalers. LABAs are called long-acting because their effects last for at least 12-hours.

Q3. Why is FDA requiring LABA manufacturers to have a risk management program for these medicines?

A. Despite the benefits of LABAs in helping people with asthma and C-O-P-D breathe easier, FDA's analyses indicate there is an increase in the risk of severe worsening of asthma symptoms in some patients with asthma that use a LABA compared to patients with asthma that do not use a LABA. Because of this risk, FDA wants to make sure LABAs are used appropriately in patients with asthma. Even though LABAs are approved for use in asthma and C-O-P-D, FDA's new recommendations ONLY apply to the use of LABAs in the treatment of asthma. In order to ensure the safe use of these medicines, FDA is requiring the manufacturers of LABAs to develop this risk management program for healthcare professionals and patients.

Q4. What is the goal of the new risk management program for LABAs?

A. The risk management program for LABAs requires the manufacturers to better inform healthcare professionals and patients about the risk of LABAs for patients with asthma and ways to decrease that risk while maintaining the benefits of the drug. Under the program, patients who have a prescription filled for a LABA will receive a revised Medication Guide that explains the risks and benefits of the medicine. In addition manufacturers of LABAs will update the prescribing information they provide to healthcare professionals to include the latest recommendations for safe use of these important medicines.

Q5. What are the key points people should know about the safe use of LABAs in patients with asthma?

A. The key points are:

  • The use of LABAs is contraindicated without the use of an asthma controller medication such as 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.

Q6. What are the names of LABA-containing medicines used to treat asthma?

A. Those medications are Servent Diskus and Foradil Aerolizer, both of which are approved for asthma, C-O-P-D, and exercise-induced bronchospasm. Foradil Certihaler (which is not currently marketed in the United States), and Advair HFA, which are approved for asthma only.

Advair Diskus and Symbicort are approved for both asthma and C-O-P-D, while Brovana and Perforomist are only approved for C-O-P-D treatment.

Q7. Why should LABAs only be used with an asthma controller medication, are they safer when used this way?

A. At this time, there is no conclusive evidence that the combination of an asthma controller medicine with a LABA decreases or eliminates the risk of a LABA. More study and analysis is required in this area. However, because of the risks of LABAs, FDA recommends that a LABA should not be used for a patient whose asthma can be controlled with an asthma controller medicine, such as an inhaled corticosteroid.  If a LABA needs to be added to that medicine, it should only be used until the patient's healthcare professional determines their asthma is under control, and then the LABA should be stopped if possible.  This means it is always necessary for a patient to use a LABA in combination with an asthma controller medication.

As part of today's announcement, FDA is requiring the manufacturers of LABAs to conduct studies evaluating the safety of LABAs when used with an inhaled corticosteroid to better understand this issue.

Q8. If LABAs are to be used with an asthma controller medicine, why aren't all LABA products required by FDA to be in a combination product with an asthma controller medicine?

A. There are several kinds of asthma controller medicines patients may use in combination with a LABA, but not all are able to be made into a combination product. For example, there are many different inhaled corticosteroids available and some pills, such as Singulair or prednisone, which patients may take with a LABA. This means that some single ingredient LABA products need to be available for patients whose other asthma controller medicine cannot be combined in the same inhaled dose. Additionally, single ingredient LABA products are used in the treatment of C-O-P-D.

Q9. Is the use of LABAs without the use of an asthma controller medication a big problem in the treatment of asthma?

A. No, currently, about 95 percent of patients using a LABA use an inhaled combination product that contains a LABA and a corticosteroid. However, discontinuation of the LABA once control of asthma is achieved is not currently a widespread practice; therefore, many patients who are using a combination LABA product may be unnecessarily exposed to the risks of LABAs. FDA is emphasizing its recommendation that when LABAs are needed that they be used for the shortest time possible to achieve asthma control and then be discontinued, if possible, to limit the long-term use.

Q10. Why is the new risk management program designed for patients with asthma and not for patients with COPD, aren't LABAs used to treat both conditions?

A. LABAs are used to treat both asthma and C-O-P-D, however, the studies reviewed by FDA included patients using LABAs for the treatment of asthma. These studies indicated an increased risk of severe worsening of asthma symptoms leading to hospitalization and death in these patients. There is no evidence to conclude that people with C-O-P-D who use LABAs are at any greater risk compared to people with C-O-P-D who do not use LABAs. FDA does not recommend any change in the use of LABAs for C-O-P-D.

FDA asks health care professionals and patients to report any adverse events from the use of LABA medications to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.

 

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