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

References

1. 1.↵
   Forum of International Respiratory Societies. The Global Impact of Respiratory Disease, Second Edition. Sheffield, UK: Forum of International Respiratory Societies; 2017.
2. 2.↵
   1. Kochanek KD,
   2. Murphy SL,
   3. Xu J,
   4. Arias E

   . Deaths: final data for 2017. Natl Vital Stat Rep 2019;68(9):1-77.

   OpenUrlPubMed
3. 3.↵
   Global Asthma Network Steering Group, Global Asthma Network Study Group. Global Asthma Report 2014. Available at: http://globalasthmanetwork.org/publications/Global_Asthma_Report_2014.pdf. Accessed March 25, 2021.
4. 4.↵
   1. Nurmagambetov T,
   2. Kuwahara R,
   3. Garbe P

   . The economic burden of asthma in the United States, 2008–2013. Ann Am Thorac Soc 2018;15(3):348-356.

   OpenUrlCrossRefPubMed
5. 5.↵
   1. Ford ES,
   2. Murphy LB,
   3. Khavjou O,
   4. Giles WH,
   5. Holt JB,
   6. Croft JB

   . Total and state-specific medical and absenteeism costs of COPD among adults aged ≥18 years in the United States for 2010 and projections through 2020. Chest 2015;147(1):31-45.

   OpenUrlCrossRefPubMed
6. 6.↵
   1. Kim D,
   2. Chen Z,
   3. Zhou LF,
   4. Huang SX

   . Air pollutants and early origins of respiratory diseases. Chronic Dis Transl Med 2018;4(2):75-94.

   OpenUrl
7. 7.↵
   1. Raj N,
   2. Fernandes S,
   3. Charyulu NR,
   4. Dubey A,
   5. G SR,
   6. Hebbar S

   . Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada. Ther Adv Drug Saf 2019;10:2042098619865413.

   OpenUrl
8. 8.↵
   1. Caster O,
   2. Aoki Y,
   3. Gattepaille LM,
   4. Grundmark B

   . Disproportionality analysis for pharmacovigilance signal detection in small databases or subsets: recommendations for limiting false-positive associations. Drug Saf 2020;43(5):479-487.

   OpenUrlPubMed
9. 9.↵
   1. Coleman JJ,
   2. Pontefract SK

   . Adverse drug reactions. Clin Med (Lond) 2016;16(5):481-485.

   OpenUrl
10. 10.↵
    1. Mims JW

    . Asthma: definitions and pathophysiology. Int Forum Allergy Rhinol 2015;5(Suppl 1):S2-S6.

    OpenUrl
11. 11.↵
    1. Vestbo J

    . COPD: definition and phenotypes. Clin Chest Med 2014;35(1):1-6.

    OpenUrlCrossRefPubMedWeb of Science
12. 12.↵
    AstraZeneca. Symbicort (budesonide and formoterol fumarate dihydrate). Available at: https://www.mysymbicort.com. Accessed May 12, 2021.
13. 13.↵
    GlaxoSmithKline. Breo Ellipta (fluticasone furoate and vilanterol inhalation powder). Available at: https://www.mybreo.com. Accessed May 12, 2021.
14. 14.↵
    GlaxoSmithKline. Advair Diskus (fluticasone propionate and salmeterol inhalation powder). Available at: https://www.advair.com. Accessed May 12, 2021.
15. 15.↵
    1. Banda JM,
    2. Evans L,
    3. Vanguri RS,
    4. Tatonetti NP,
    5. Ryan PB,
    6. Shah NH

    . A curated and standardized adverse drug event resource to accelerate drug safety research. Sci Data 2016;3:160026.

    OpenUrl
16. 16.↵
    1. Donohue JF,
    2. Niewoehner D,
    3. Brooks J,
    4. O'Dell D,
    5. Church A

    . Safety and tolerability of once-daily umeclidinium/vilanterol 125/25 mcg and umeclidinium 125 mcg in patients with chronic obstructive pulmonary disease: results from a 52-week, randomized, double-blind, placebo-controlled study. Respir Res 2014;15(1):78.

    OpenUrlPubMed
17. 17.↵
    1. Maltais F,
    2. Bjermer L,
    3. Kerwin EM,
    4. Jones PW,
    5. Watkins ML,
    6. Tombs L,
    7. et al

    . Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial. Respir Res 2019;20(1):238.

    OpenUrl
18. 18.↵
    AstraZeneca. Daliresp (roflumilast). Available at: https://www.daliresp.com. Accessed May 12, 2021.
19. 19.↵
    1. Rennard SI,
    2. Calverley PMA,
    3. Goehring UM,
    4. Bredenbröker D,
    5. Martinez FJ

    . Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD. Respir Res 2011;12(1):18.

    OpenUrlCrossRefPubMed
20. 20.↵
    1. Cilli A,
    2. Bal H,
    3. Gunen H

    . Efficacy and safety profile of roflumilast in a real-world experience. J Thorac Dis 2019;11(4):1100-1105.

    OpenUrl
21. 21.↵
    FDA Drug Safety Communication. FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). April 15, 2011. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-review-finds-no-significant-increase-risk-serious-asthma-outcomes. Accessed March 1, 2021.
22. 22.↵
    1. Welch HK,
    2. Kellum JA,
    3. Kane-Gill S

    . Drug-associated acute kidney injury identified in the United States Food and Drug Administration Adverse Event Reporting System database. Pharmacotherapy 2018;38(8):785-793.

    OpenUrl
23. 23.
    1. Gray MP,
    2. Dziuba G,
    3. Quach K,
    4. Wong A,
    5. Smithburger PL,
    6. Seybert AL,
    7. Kane-Gill SL

    . Assessing adverse drug reactions from psychotropic medications reported to the U.S. Food and Drug Administration in older adults. Am J Geriatr Psychiatry 2019;27(2):181-185.

    OpenUrl
24. 24.↵
    1. Patel NM,
    2. Stottlemyer BA,
    3. Gray MP,
    4. Boyce RD,
    5. Kane-Gill SL

    . A pharmacovigilance study of adverse drug reactions reported for cardiovascular disease medications approved between 2012 and 2017 in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Cardiovasc Drugs Ther. 2021 [Epub ahead of print].
25. 25.↵
    1. Arora A,
    2. Jalali RK,
    3. Vohora D

    . Relevance of the Weber effect in contemporary pharmacovigilance of oncology drugs. Ther Clin Risk Manag 2017;13:1195-1203.

    OpenUrl