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 EventFORADIL AEROLIZER12 mcg twice dailyPlacebo
    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 dailyForadil 24 mcg twice dailyAlbuterol 180 mcg four times dailyPlacebo
    Trial #1
    Serious asthma exacerbations0/136 (0)4/135 (3.0%)12/134 (1.5%)0/136 (0)
    Trial #2
    Serious asthma exacerbations1/139 (0.7%)5/136 (3.7%)20/138 (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
    Foradil 12 mcg twice dailyForadil 24 mcg twice dailyPlacebo
    Serious asthma exacerbations3/527 (0.6%)2/527 (0.4%)1/514 (0.2%)
  • Experience in Children with Asthma

  • The safety of FORADIL AEROLIZER 12 mcg twice daily compared to FORADIL AEROLIZER 24 mcg twice daily and placebo was investigated in one large, multicenter, randomized, double-blind, 52-week clinical trial in 518 children with asthma (ages 5-12 years) in need of daily bronchodilators and anti-inflammatory treatment. More children who received FORADIL AEROLIZER 24 mcg twice daily than children who received FORADIL AEROLIZER 12 mcg twice daily or placebo experienced serious asthma exacerbations, as shown in the next table.

    Number and frequency of serious asthma exacerbations in patients 5-12 years of age from a 52-week trial
    Foradil 12 mcg twice dailyForadil 24 mcg twice dailyPlacebo
    Serious asthma exacerbations8/171 (4.7%)11/171 (6.4%)0/176 (0)

    The numbers and percent of patients who reported adverse events were comparable in the 12 mcg twice daily and placebo groups. In general, the pattern of the adverse events observed in children differed from the usual pattern seen in adults. The adverse events that were more frequent in the formoterol group than in the placebo group reflected infection/inflammation (viral infection, rhinitis, tonsillitis, gastroenteritis) or abdominal complaints (abdominal pain, nausea, dyspepsia).

  • Experience in Adult Patients with COPD

  • Of the 1634 patients in two pivotal multiple-dose Chronic Obstructive Pulmonary Disease (COPD) controlled trials, 405 were treated with FORADIL AEROLIZER 12 mcg twice daily. The numbers and percent of patients who reported adverse events were comparable in the 12 mcg twice daily and placebo groups. Adverse events (AE's) experienced were similar to those seen in asthmatic patients, but with a higher incidence of COPD-related AE's in both placebo and formoterol treated patients.

    The following table shows adverse events where the frequency was greater than or equal to 1% in the FORADIL AEROLIZER group and where the rates in the FORADIL AEROLIZER group exceeded placebo. The two clinical trials included doses of 12 mcg and 24 mcg, administered twice daily. Seven adverse events showed dose ordering among tested doses of 12 and 24 mcg administered twice daily; pharyngitis, fever, muscle cramps, increased sputum, dysphonia, myalgia, and tremor.

    NUMBER AND FREQUENCY OF ADVERSE EXPERIENCES IN ADULT COPD PATIENTS TREATED IN MULTIPLE-DOSE CONTROLLED CLINICAL TRIALS
    Adverse EventFORADIL AEROLIZER12 mcg twice dailyPlacebo
    n (%) n (%)
    Total patients 405(100)420(100)
    Upper respiratory tract infection 30(7.4)24(5.7)
    Pain back 17(4.2)17(4.0)
    Pharyngitis 14(3.5)10(2.4)
    Pain chest 13(3.2)9(2.1)
    Sinusitis 11(2.7)7(1.7)
    Fever 9(2.2)6(1.4)
    Cramps leg 7(1.7)2(0.5)
    Cramps muscle7(1.7)0
    Anxiety 6(1.5)5(1.2)
    Pruritis 6(1.5)4(1.0)
    Sputum increased 6(1.5)5(1.2)
    Mouth dry 5(1.2)4(1.0)

    Overall, the frequency of all cardiovascular adverse events in the two pivotal studies was low and comparable to placebo (6.4% for FORADIL AEROLIZER 12 mcg twice daily, and 6.0% for placebo). There were no frequently-occurring specific cardiovascular adverse events for FORADIL AEROLIZER (frequency greater than or equal to 1% and greater than placebo).

    Other adverse reactions to FORADIL AEROLIZER are similar in nature to other selective beta2-adrenoceptor agonists; e.g., angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.

  • Post Marketing Experience

  • In extensive worldwide marketing experience with FORADIL, serious exacerbations of asthma, including some that have been fatal, have been reported. While most of these cases have been in patients with severe or acutely deteriorating asthma (see WARNINGS), a few have occurred in patients with less severe asthma. It is not possible to determine from these individual case reports whether FORADIL AEROLIZER contributed to the events.

    Rare reports of anaphylactic reactions, including severe hypotension and angioedema, have also been received in association with the use of formoterol fumarate inhalation powder.

  • Drug Information Provided by National Library of Medicine (NLM).
Ads