FDA Announces Label Changes for Asthma Medications: Serevent and Foradil

Due to risks including severe exacerbation of asthma symptoms, the FDA recently announced label changes intend to promote safe use of two long-acting beta agonists (LABA) approved for asthma, salmeterol (Serevent) and formoterol (Foradil). Labels will be changed to require that the drugs always be used in combination with an asthma controller medication such as an inhaled corticosteroid. Additional precautions include:

  • LABAs should only be used long-term in patients with asthma not adequately controlled with inhaled steroids or other controller medications.
  • The agents should be used for the shortest time possible to achieve symptom control. Once patients are no longer experiencing symptoms, LABAs should be discontinued if possible with patients maintained on controller medications alone.
  • Children and adolescents needing a LABA should use a combination product that also contains an inhaled steroid to ensure compliance with both medications.

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