Información de la droga para Foradil Aerolizer (Schering Corporation): ADVERSE REACTIONS

Ads
  • Clinical trials with FORADIL AEROLIZER suggested a higher incidence of serious asthma exacerbations in patients who received FORADIL AEROLIZER than in those who received placebo.

  • Experience in Pediatric, Adolescent and Adult Patients with Asthma

  • Of the 5,824 patients in multiple-dose controlled clinical trials, 1,985 were treated with FORADIL AEROLIZER at the recommended dose of 12 mcg twice daily. The following table shows adverse events where the frequency was greater than or equal to 1% in the FORADIL twice daily group and where the rates in the FORADIL group exceeded placebo. Three adverse events showed dose ordering among tested doses of 6, 12 and 24 mcg administered twice daily; tremor, dizziness and dysphonia.

    NUMBER AND FREQUENCY OF ADVERSE EXPERIENCES IN PATIENTS 5 YEARS OF AGE AND OLDER FROM MULTIPLE-DOSE CONTROLLED CLINICAL TRIALS
    Adverse Event FORADIL AEROLIZER12 mcg twice daily Placebo
    n (%) n (%)
    Total Patients 1985 (100) 969 (100)
    Infection viral 341 (17.2) 166 (17.1)
    Bronchitis 92 (4.6) 42 (4.3)
    Chest infection 54 (2.7) 4 (0.4)
    Dyspnea 42 (2.1) 16 (1.7)
    Chest pain 37 (1.9) 13 (1.3)
    Tremor 37 (1.9) 4 (0.4)
    Dizziness 31 (1.6) 15 (1.5)
    Insomnia 29 (1.5) 8 (0.8)
    Tonsilitis 23 (1.2) 7 (0.7)
    Rash 22 (1.1) 7 (0.7)
    Dysphonia 19 (1.0) 9 (0.9)

    In two 12-week controlled trials with combined enrollment of 1095 patients 12 years of age and older, FORADIL AEROLIZER 12 mcg twice daily was compared to FORADIL AEROLIZER 24 mcg twice daily, albuterol 180 mcg four times daily, and placebo. Serious asthma exacerbations (acute worsening of asthma resulting in hospitalization) occurred more commonly with FORADIL AEROLIZER 24 mcg twice daily than with the recommended dose of FORADIL AEROLIZER 12 mcg twice daily, albuterol, or placebo. The results are shown in the following table.

    Number and frequency of serious asthma exacerbations in Patients 12 years of age and older from two 12-week controlled clinical trials
    Foradil 12 mcg twice daily Foradil 24 mcg twice daily Albuterol 180 mcg four times daily Placebo
    Trial #1
    Serious asthma exacerbations 0/136 (0) 4/135 (3.0%)1 2/134 (1.5%) 0/136 (0)
    Trial #2
    Serious asthma exacerbations 1/139 (0.7%) 5/136 (3.7%)2 0/138 (0) 2/141 (1.4%)
    1 1 patient required intubation2 2 patients had respiratory arrest; 1 of the patients died

    In a 16-week, randomized, multi-center, double-blind, parallel-group trial, patients who received either 24 mcg twice daily or 12 mcg twice daily doses of FORADIL AEROLIZER experienced more serious asthma exacerbations than patients who received placebo (see CLINICAL TRIALS). The results are shown in the following table.

    Number and frequency of serious asthma exacerbations in patients 12 years of age and older from a 16-week trial