Children aged 4–11 years appeared to be at the greatest risk, compared with other age groups. In addition, black patients were at a greater risk than other races, and women were at a greater risk than men.
For Advair, the panels voted 27–0 in favor of the benefit-risk profile for adults aged 18 years and older, and 23-3 with 1 abstention for adolescents aged 12–17 years.
For Symbicort the panel voted 26-0 with 1 abstention in favor of the benefit-risk profile in adults aged 18 years and older, and 20-5 with 2 abstentions for adolescents aged 12–17 years.
The panelists agreed that the benefits of Serevent did not outweigh its risks for maintenance treatment of asthma in adults by a vote of 17–10, in adolescents by a vote of 21-6, and in children aged 4–11 years by unanimous vote.
For Foradil, the panels agreed that the benefits did not outweigh its risks in adults by a vote of 18-9, and in adolescents by a vote of 21-6. The panels also unanimously agreed that the benefits of Foradil did not outweigh its risks in younger children.
The FDA usually follows the recommendations of its advisory panels, which are not binding.