FDA Approves Removal of Box Warning From Advair, Breo Asthma Therapies

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The FDA approved removal of the boxed warning from Advair and Breo following review of safety data from 4 randomized controlled safety trials.
The FDA approved removal of the boxed warning from Advair and Breo following review of safety data from 4 randomized controlled safety trials.

The US Food and Drug Administration has ruled that GlaxoSmithKline may remove boxed warning labels from several inhaled corticosteroid/long-acting beta2 agonist (ICS/LABA) combination medications, according to a press release.1 Warnings and Precautions labeling for ICS/LABA-class medications was also updated.

The list of medications includes Breo Ellipta® (fluticasone furoate/vilanterol), Advair® Diskus (fluticasone propionate/salmeterol), and Advair® HFA.

The FDA decision follows review of data from 4 randomized controlled safety trials, two of which were submitted by GlaxoSmithKline.

The first trial (AUSTRI, SAS115359; ClinicalTrials.gov Identifier: NCT01475721) was a 26-week study of controller treatment in adolescents and adults with asthma. Researchers sought to determine if LABA plus ICS therapy was noninferior to ICS therapy alone concerning the risk of a composite of several serious adverse events. Full study results were published in The New England Journal of Medicine.2

The second trial (VESTRI, SAS115358; ClinicalTrials.gov Identifier: NCT01462344) also examined if the addition of LABA to ICS therapy is noninferior to ICS therapy alone in patients between 4 and 11 years of age. Primary analyses included the risk of a composite of serious asthma-related adverse events. Full study results were also published in The New England Journal of Medicine.3

The most common adverse reactions associated with Advair Diskus and HFA include upper respiratory tract infection, sinusitis, pharyngitis, and upper respiratory inflammation. The most common adverse reactions associated with Breo are nasopharyngitis, headache, oropharyngeal pain, and oral candidiasis, among others.

References

  1. FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data [news release]. London, UK: GlaxoSmithKline. Published December 21, 2017. Accessed December 21, 2017.
  2. Stempel DA, Raphiou IH, Kral KM, et al; for the AUSTRI Investigators. Serious asthma events with fluticasone plus salmeterol versus fluticasone alone. N Engl J Med. 2016;374:1882-1830.
  3. Stempel DA, Szefler SJ, Pedersen S, et al; for the VESTRI Investigators. Safety of adding salmeterol to fluticasone propionate in children with asthma. N Engl J Med. 2016;375:840-849. 

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