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FDA Urges Safe Use of Certain Inhaled Asthma Medicines

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In addition to following the recommendations issued on Feb. 18, FDA advises patients to

  • know that 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
  • know that, if they need a LABA plus an asthma controller medication that is not available as a combination product, they should work with their health care professionals to ensure that each individual medication is taken correctly
  • read the Medication Guide included in each LABA
  • talk with their health care professionals to learn the warning signs of worsening asthma, and to discuss any questions they have about the use of LABAs

Other FDA Actions

On Feb. 18, FDA also

  • required that the product labels for LABAs reflect the agency's recommendations
  • called on manufacturers of LABAs to conduct additional studies to further evaluate the safety of these medicines when used in combination with inhaled corticosteroids
  • said it will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices

required a risk management program—called a Risk Evaluation and Mitigation Strategy (REMS)—to help ensure the safe use of these products. The program requires the manufacturers to better inform health care 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


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