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Research ArticleOriginal Research

Assessing Adverse Drug Reactions Reported for New Respiratory Medications in the FDA Adverse Event Reporting System Database

Hyunwoo Kim, Colin M Pfeiffer, Matthew P Gray, Britney A Stottlemyer, Richard D Boyce and Sandra L Kane-Gill
Respiratory Care November 2021, 66 (11) 1739-1745; DOI: https://doi.org/10.4187/respcare.08809
Hyunwoo Kim
School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
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Colin M Pfeiffer
School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
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Matthew P Gray
School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
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Britney A Stottlemyer
School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
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Richard D Boyce
Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania.
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Sandra L Kane-Gill
School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
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  • For correspondence: [email protected]
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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: A total of 61,682 ADR reports were collected for newly approved CLRD medications (n = 27,190 older adults; n = 30,502 male). Reports of COPD medications (umeclidinium and umeclidinium/vilanterol) indicate that umeclidinium/vilanterol yielded a higher reporting odds ratio than umeclidinium alone for reports of pain. Fluticasone furoate/vilanterol had higher reporting odds ratios for cough, pain, and dizziness than budesonide/formoterol and fluticasone propionate/salmeterol.

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.

  • pharmacovigilance
  • post-marketing
  • chronic obstructive pulmonary disease
  • asthma
  • reporting odds ratio
  • adverse drug reaction

Footnotes

  • Correspondence: Sandra L Kane-Gill PharmD MSc, University of Pittsburgh, School of Pharmacy, PRESBY/SHY Pharmacy Administration Building, 3507 Victoria St, Mailcode PFG-01-01-01, Pittsburgh, PA 15213. E-mail: kane-gill{at}pitt.edu
  • Supplementary material related to this paper is available at http://www.rcjournal.com.

  • The authors have disclosed no conflicts of interest.

  • Copyright © 2021 by Daedalus Enterprises
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Respiratory Care: 66 (11)
Respiratory Care
Vol. 66, Issue 11
1 Nov 2021
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Assessing Adverse Drug Reactions Reported for New Respiratory Medications in the FDA Adverse Event Reporting System Database
Hyunwoo Kim, Colin M Pfeiffer, Matthew P Gray, Britney A Stottlemyer, Richard D Boyce, Sandra L Kane-Gill
Respiratory Care Nov 2021, 66 (11) 1739-1745; DOI: 10.4187/respcare.08809

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Assessing Adverse Drug Reactions Reported for New Respiratory Medications in the FDA Adverse Event Reporting System Database
Hyunwoo Kim, Colin M Pfeiffer, Matthew P Gray, Britney A Stottlemyer, Richard D Boyce, Sandra L Kane-Gill
Respiratory Care Nov 2021, 66 (11) 1739-1745; DOI: 10.4187/respcare.08809
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Keywords

  • pharmacovigilance
  • post-marketing
  • chronic obstructive pulmonary disease
  • asthma
  • reporting odds ratio
  • adverse drug reaction

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