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Beta2-Agonist Adverse Reaction Profile
Adverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta2-adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis.
Clinical Trials Experience
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 practice.
Adults with COPD
The data described below reflect exposure to PERFOROMIST Inhalation Solution 20 mcg twice daily by oral inhalation in 586 patients, including 232 exposed for 6 months and 155 exposed for at least 1 year. PERFOROMIST Inhalation Solution was studied in a 12-week, placebo-and active-controlled trial (123 subjects treated with PERFOROMIST Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with PERFOROMIST Inhalation Solution). Patients were mostly Caucasians (88%) between 40-90 years old (mean, 64 years old) and had COPD, with a mean FEV1 of 1.33 L. Patients with significant concurrent cardiac and other medical diseases were excluded from the trials.
Table 1 shows adverse reactions from the 12-week, double-blind, placebo-controlled trial where the frequency was greater than or equal to 2% in the PERFOROMIST Inhalation Solution group and where the rate in the PERFOROMIST Inhalation Solution group exceeded the rate in the placebo group. In this trial, the frequency of patients experiencing cardiovascular adverse events was 4.1% for PERFOROMIST Inhalation Solution and 4.4% for placebo. There were no frequently occurring specific cardiovascular adverse events for PERFOROMIST Inhalation Solution (frequency greater than or equal to 1% and greater than placebo). The rate of COPD exacerbations was 4.1% for PERFOROMIST Inhalation Solution and 7.9% for placebo.
TABLE 1 : Number of patients with adverse reactions in
the 12-week multiple-dose controlled clinical trial
|Inhalation Solution 20 mcg|
Patients treated with PERFOROMIST Inhalation Solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.
The following adverse reactions have been reported during post-approval use of PERFOROMIST. 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.
Read the Perforomist (formoterol fumarate inhalation solution) Side Effects Center for a complete guide to possible side effects
If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol may be potentiated [see WARNINGS AND PRECAUTIONS].
Xanthine Derivatives, Steroids, or Diuretics
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists [see WARNINGS AND PRECAUTIONS].
Non-potassium Sparing Diuretics
The ECG changes and/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 co-administration of beta-agonists with non-potassium sparing diuretics.
MAO Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs
Formoterol, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the effect 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-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 beta-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD 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 COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
Read the Perforomist Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/20/2012
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