Inhaled Corticosteroids and LABAs - Removal of the FDA's Boxed Warning

N Engl J Med. 2018 Jun 28;378(26):2461-2463. doi: 10.1056/NEJMp1716858.

Authors

Sally M Seymour¹, Robert Lim¹, Changming Xia¹, Eugenio Andraca-Carrera¹, Badrul A Chowdhury¹

Affiliation

¹ From the Office of New Drugs (S.M.S., R.L., B.A.C.) and the Office of Translational Sciences ( C.X., E.A.-C.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

PMID: 29949485
DOI: 10.1056/NEJMp1716858

No abstract available

MeSH terms

Administration, Inhalation
Adolescent
Adrenal Cortex Hormones / administration & dosage*
Adrenal Cortex Hormones / adverse effects
Adrenergic beta-Agonists / administration & dosage
Adrenergic beta-Agonists / adverse effects*
Adult
Anti-Asthmatic Agents / administration & dosage
Anti-Asthmatic Agents / adverse effects*
Budesonide, Formoterol Fumarate Drug Combination / therapeutic use
Child
Clinical Trials as Topic
Delayed-Action Preparations
Drug Combinations*
Drug Labeling*
Fluticasone-Salmeterol Drug Combination / therapeutic use
Government Regulation
Humans
Mometasone Furoate, Formoterol Fumarate Drug Combination / therapeutic use
United States
United States Food and Drug Administration

Substances

Adrenal Cortex Hormones
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Budesonide, Formoterol Fumarate Drug Combination
Delayed-Action Preparations
Drug Combinations
Fluticasone-Salmeterol Drug Combination
Mometasone Furoate, Formoterol Fumarate Drug Combination