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Foradil Aerolizer

Side Effects
Interactions

SIDE EFFECTS

Long-acting beta2-adrenergic agonists (LABA), including formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death and may increase the risk of asthma-related hospitalizations in pediatric and adolescent patients. 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 [see WARNINGS AND PRECAUTIONS].

Adverse reactions common to LABA drugs include: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical trials.

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 treatment-emergent adverse reactions 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 treatment-emergent adverse reactions showed dose ordering among tested doses of 6, 12 and 24 mcg administered twice daily; tremor, dizziness and dysphonia.

Number and Frequency of Treatment-Emergent Adverse Reactions in Patients 5 Years of Age and Older from Multiple-Dose Controlled Clinical Trials

Treatment-Emergent
Adverse Reaction
Foradil Aerolizer 12 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) 9 (0.9)

In patients 5-12 years of age, the numbers and percent of patients who reported treatment-emergent adverse reactions were comparable in the 12 mcg twice daily and placebo groups. In general, the pattern of the treatment-emergent adverse reactions observed in children differed from the usual pattern seen in adults. Treatment-emergent adverse reactions 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).

Serious Asthma Exacerbations in Adolescents and Adults 12 Years of Age and Older

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%)
1patient required intubation
2patients 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 daily Foradil 24 mcg twice daily Placebo
Serious asthma exacerbations 3/527 (0.6%) 2/527 (0.4%) 1/514 (0.2%)

Serious Asthma Exacerbations in Children 5-11 Years of Age

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 daily Foradil 24 mcg twice daily Placebo
Serious asthma exacerbations 8/171 (4.7%) 11/171 (6.4%) 0/176 (0)

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. Treatment-emergent adverse reactions reported were similar to those seen in asthmatic patients, but with a higher incidence of COPD-related events in both placebo and formoterol treated patients.

The following table shows treatment-emergent adverse reactions 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 treatment-emergent adverse reactions 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 Treatment-Emergent Adverse Reactions in Adult COPD Patients Treated in Multiple-Dose Controlled Clinical Trials

Treatment-Emergent
Adverse Reaction
Foradil Aerolizer 12 mcg twice daily Placebo
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)
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 muscle 7 (1.7) 0
Anxiety 6 (1.5) 5 (1.2)
Pruritis 6 (1.5) 4 (1)
Sputum increased 6 (1.5) 5 (1.2)
Mouth dry 5 (1.2) 4 (1)

Overall, the frequency of all cardiovascular treatment-emergent adverse reactions in the two pivotal studies was6.4% for FORADIL AEROLIZER 12 mcg twice daily, and 6.0% for placebo. There were no frequently-occurring specific cardiovascular treatment-emergent adverse reactions for FORADIL AEROLIZER (frequency greater than or equal to 1% and greater than placebo).

Post Marketing Experience

The following adverse reactions have been identified during post approval use of FORADIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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 AND PRECAUTIONS], 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.

Immune system disorders: rare reports of anaphylactic reactions, including severe hypotension and angioedema

Metabolism and nutrition disorders: Hypokalemia, hyperglycemia

Respiratory, thoracic and mediastinal disorders: Cough

Skin and subcutaneous tissue disorders: Rash

Cardiac disorders: Atrial fibrillation, angina pectoris, ventricular extrasystoles, tachyarrhythmia

Investigations: Electrocardiogram QT prolonged, blood pressure increased (including hypertension)

Read the Foradil Aerolizer (formoterol fumarate inhalation powder) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Adrenergic Drugs

If additional adrenergic drugs are to be administered by any route, they should be used with caution because the pharmacologically predictable sympathetic effects of formoterol may be potentiated.

Xanthine Derivatives or Systemic Corticosteroids

Concomitant treatment with xanthine derivatives or systemic corticosteroids may potentiate any hypokalemic effect of adrenergic agonists.

Diuretics

The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonist with non-potassium sparing diuretics.

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants, QTc Prolonging Drugs

Formoterol, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.

Beta-blockers

Beta-adrenergic receptor antagonists (beta-blockers) and formoterol may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta2-agonists, such as formoterol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

Read the Foradil Aerolizer Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/2/2012
This monograph has been modified to include the generic and brand name in many instances.

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Foradil Aerolizer - User Reviews

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