Serious asthma exacerbations in asthmatics treated with high-dose formoterol.
OBJECTIVE
To review three prospective, randomized, placebo-controlled, double-blind clinical studies of formoterol (Foradil Aerolizer; Novartis Pharmaceuticals; Basel, Switzerland) at dosages of 12 microg and 24 microg bid for the treatment of patients with asthma.


METHODS
Clinical studies submitted to the US Food and Drug Administration in support of the approval of Foradil Aerolizer for marketing in the United States.


RESULTS
More patients treated regularly with formoterol, 24 micro g bid, had a serious asthma exacerbation than did patients who had been treated with placebo. In the first study, 4 of 135 adult patients (3%) who had been treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to none of 136 placebo-treated patients. In the second study, 5 of 136 patients (3.7%) treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to 2 of 141 placebo-treated patients (1.4%). In the third study, 11 of 171 pediatric patients (6.4%) treated with formoterol, 24 microg bid, had a serious asthma exacerbation compared to none of 176 placebo-treated patients.


CONCLUSIONS
Regular use of high-dose inhaled formoterol (24 microg bid) may be associated with more frequent serious asthma exacerbations.
Mann
Marianne
M
Division of Pulmonary and Allergy Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857, USA.
Chowdhury
Badrul
B
Sullivan
Eugene
E
Nicklas
Richard
R
Anthracite
Raymond
R
Meyer
Robert J
RJ
D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000328:Adult; D001249:Asthma / Q000139:chemically induced* / Q000188:drug therapy; D002648:Child; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000068759:Formoterol Fumarate; D006801:Humans; D011446:Prospective Studies
D000318:Adrenergic beta-Agonists; D004983:Ethanolamines; D000068759:Formoterol Fumarate