Foradil Certihaler

SIDE EFFECTS

Long-acting beta₂-adrenergic agonists (LABA), including formoterol, the active ingredient in FORADIL CERTIHALER (formoterol fumarate inhalation powder) , 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 (consists of a single-dose dry powder inhaler and capsules containing formoterol fumarate and lactose) suggested a higher incidence of serious asthma exacerbations in patients who received FORADIL AEROLIZER than in those who received placebo. (See WARNINGS)

Experience in Pediatric, Adolescent and Adult Patients with Asthma

Of the 1,118 patients in multiple-dose controlled clinical trials of more than one month exposure, 414 were treated with FORADIL CERTIHALER (formoterol fumarate inhalation powder) at the recommended dose of 10 mcg twice daily. The following table shows adverse events where the frequency was greater than or equal to 1% in the FORADIL 10 mcg twice daily group and where the rates in the FORADIL group exceeded placebo.

NUMBER AND FREQUENCY OF ADVERSE EXPERIENCES IN PATIENTS 5 YEARS OF AGE AND OLDER FROM MULTIPLE-DOSE CONTROLLED CLINICAL TRIALS OF MORE THAN ONE MONTH EXPOSURE

In two 12-week controlled trials for FORADIL AEROLIZER 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

A 16-week, randomized, multi-center, double-blind, parallel-group study of FORADIL AEROLIZER enrolled 1568 patients 12 years of age and older with mild-to-moderate asthma (defined as FEV₁ ≥ 40% of the patient's predicted normal value) in three treatment groups. The study's primary endpoint was the incidence of serious asthma-related adverse events. Patients who received either 24 mcg or 12 mcg twice daily doses of FORADIL AEROLIZER experienced more serious asthma exacerbations than patients who received 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 A 16-WEEK TRIAL

The size of this study was not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups. All serious asthma exacerbations resulted in hospitalizations. While there were no deaths in the study, the duration and size of this study were not adequate to quantify the rate of asthma-related death. See WARNINGS for information about a study which compared another long-acting beta₂-adrenergic agonist to placebo.

Experience in Children with Asthma

The safety of FORADIL CERTIHALER (formoterol fumarate inhalation powder) compared to placebo was investigated in a large, 12-week, multicenter, randomized, double-blind clinical trial in 249 children with asthma (ages 5-12 years) in need of daily bronchodilators. The numbers and percent of patients who reported adverse events were comparable in the 10 mcg twice daily and placebo groups. In general, the adverse events observed in children were similar to those described above for the overall asthma population in multiple-dose controlled trials of at least one month exposure. Adverse events that were frequently occurring (incidence of at least 1% and greater than placebo) only for children included viral gastroenteritis, acute sinusitis, pharyngitis, abrasion, rash and contact dermatitis.

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 antiinflammatory 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

Other adverse reactions to FORADIL 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 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 Abuse And Dependence

There was no evidence in clinical trials of drug dependence with the use of FORADIL.

Read the entire FDA prescribing information for Foradil Certihaler (Formoterol Fumarate Inhalation Powder)