Abstract | BACKGROUND: Between 2012 and 2017, 25 new medications or combination products were approved by the Food and Drug Administration (FDA) for use in treatment of chronic lower respiratory diseases (CLRDs). With limited data on post-marketing patient exposure to these drugs, their safety profiles remain unknown. This study aims to provide post-marketing surveillance of these medications. METHODS: A list of new CLRD medications approved between 2012 and 2017 was generated through searches on Drugs.com (https://www.drugs.com), FDA.gov (https://www.fda.gov), and IBM Micromedex (https://www.micromedexsolutions.com/home/dispatch/ssl/true). Data describing adverse drug reactions (ADRs) were collected from the FDA Adverse Event Reporting System for analysis. Of the 25 identified medications, we selected 4 medications indicated for asthma or COPD with at least 500 reports. Only ADRs catalogued with these medications as the primary suspect were analyzed. Reporting odds ratios were calculated for the top 10 ADRs of each CLRD medication. RESULTS: CONCLUSIONS: Our findings suggest that the incidence of different adverse events experienced by patients in post-marketing reports resembles the incidence reported in pre-marketing clinical trials for COPD medications, except for fluticasone furoate/ vilanterol, which has several differences.
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Authors | Hyunwoo Kim, Colin M Pfeiffer, Matthew P Gray, Britney A Stottlemyer, Richard D Boyce, Sandra L Kane-Gill |
Journal | Respiratory care
(Respir Care)
Vol. 66
Issue 11
Pg. 1739-1745
(Nov 2021)
ISSN: 1943-3654 [Electronic] United States |
PMID | 34103383
(Publication Type: Journal Article)
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Copyright | Copyright © 2021 by Daedalus Enterprises. |
Chemical References |
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Topics |
- Administration, Inhalation
- Aged
- Bronchodilator Agents
(therapeutic use)
- Drug-Related Side Effects and Adverse Reactions
(epidemiology)
- Humans
- Male
- Pulmonary Disease, Chronic Obstructive
(drug therapy)
- United States
- United States Food and Drug Administration
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