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FDA Urges Safe Use of Certain Inhaled Asthma Medicines


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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WebMD Public Information from the FDA