Display options
Cite
Patel NM, Stottlemyer BA, Gray MP, et al. 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;doi: 10.1007/s10557-021-07157-3.
Patel, N. M., Stottlemyer, B. A., Gray, M. P., Boyce, R. D., & Kane-Gill, S. L. (2021). 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. Cardiovascular drugs and therapy, . https://doi.org/10.1007/s10557-021-07157-3
Patel, Niti M, et al. "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." Cardiovascular drugs and therapy vol. (2021). doi: https://doi.org/10.1007/s10557-021-07157-3
Patel NM, Stottlemyer BA, Gray MP, Boyce RD, 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 Feb 18; doi: 10.1007/s10557-021-07157-3. Epub 2021 Feb 18. PMID: 33599896.
Copy Download .nbib Format: NLM
Share it on

Cardiovasc Drugs Ther. 2021 Feb 18; doi: 10.1007/s10557-021-07157-3. Epub 2021 Feb 18.

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.

Cardiovascular drugs and therapy

Niti M Patel, Britney A Stottlemyer, Matthew P Gray, Richard D Boyce, Sandra L Kane-Gill

Affiliations

  1. School of Pharmacy, University of Pittsburgh, 3507 Terrace St., Pittsburgh, PA, 15261, USA.
  2. Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, PA, USA.
  3. School of Pharmacy, University of Pittsburgh, 3507 Terrace St., Pittsburgh, PA, 15261, USA. [email protected].

PMID: 33599896 DOI: 10.1007/s10557-021-07157-3

Abstract

PURPOSE: Between 2012 and 2017, the FDA approved 29 therapies for a cardiovascular disease (CVD) indication. Due to the limited literature on patient safety outcomes for recently approved CVD medications, this study investigated adverse drug reports (ADRs) reported in the FDA Adverse Event Reporting System (FAERS).

METHODS: A disproportionality analysis of spontaneously reported ADR was conducted. Reports in FAERS from Quarter 1, 2012, through Quarter 1, 2019, were compiled, allowing a 2-year buffer following drug approval in 2017. Top 10 reported ADRs and reporting odds ratios (ROR; confidence interval (CI)), a measure of disproportionality, were analyzed and compared to drugs available prior to 2012 as appropriate.

RESULTS: Of 7,952,147 ADR reports, 95,016 (1.19%) consisted of reports for newly approved CVD medications. For oral anticoagulants, apixaban had significantly lower reports for anemia and renal failure compared to dabigatran and rivaroxaban but greater reports for neurological signs/symptoms, and arrhythmias. Evaluating heart failure drugs, sacubitril/valsartan had greater reports for acute kidney injury, coughing, potassium imbalances, and renal impairment but notably, lower for angioedema compared to lisinopril. Assessing familial hypercholesterolemia drugs, alirocumab had greater reports for joint-related-signs/symptoms compared to other agents in this category. A newer pulmonary arterial hypertension treatment, selexipag, had greater reports of reporting for bone/joint-related-signs/symptoms but riociguat had greater reports for hemorrhages and vascular hypotension.

CONCLUSION: Pharmacovigilance studies allow an essential opportunity to evaluate the safety profile of CVD medications in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved CVD medications.

Keywords: Anticoagulants; Cardiovascular disease; Cardiovascular drugs; Data mining; Familial hypercholesteremia; Heart failure; Post-marketing product surveillance; Pulmonary arterial hypertension; United States FDA Adverse Event Reporting System (FAERS)

References

  1. Mensah GA, Roth GA, Fuster V. The global burden of cardiovascular diseases and risk factors: 2020 and beyond. J Am Coll Cardiol. 2019;74(20):2529–32. - PubMed
  2. Heron M. Deaths: leading causes for 2017. Natl Vital Stat Rep. 2017;68(6):77. - PubMed
  3. Cardiovascular disease: a costly burden for america projections through 2035. American Heart Association. 2017:16. - PubMed
  4. Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, et al. Heart disease and stroke statistics-2017 update: a report From the American Heart Association. Circulation. 2017;135(10):e146–603. - PubMed
  5. Leopold JA, Loscalzo J. Emerging role of precision medicine in cardiovascular disease. Circ Res. 2018;122(9):1302–15. - PubMed
  6. Khakoo AY, Yurgin NR, Eisenberg PR, Fonarow GC. Overcoming barriers to development of novel therapies for cardiovascular disease: insights from the Oncology Drug Development Experience. JACC Basic Transl Sci. 2019;4(2):269–74. - PubMed
  7. Coloma PM, Trifiro G, Patadia V, Sturkenboom M. Postmarketing safety surveillance: where does signal detection using electronic healthcare records fit into the big picture? Drug Saf. 2013;36(3):183–97. - PubMed
  8. Vlahovic-Palcevski V, Mentzer D. Postmarketing surveillance. Handb Exp Pharmacol. 2011;205:339–51. - PubMed
  9. Klein E, Bourdette D. Postmarketing adverse drug reactions: a duty to report? Neurol Clin Pract. 2013;3(4):288–94. - PubMed
  10. Fang H, Su Z, Wang Y, Miller A, Liu Z, Howard PC, et al. Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics. Clin Pharmacol Ther. 2014;95(5):496–8. - PubMed
  11. van der Laan DM, Elders PJM, Boons C, Nijpels G, Krska J, Hugtenburg JG. The impact of cardiovascular medication use on patients’ daily lives: a cross-sectional study. Int J Clin Pharm. 2018;40(2):412–20. - PubMed
  12. Food and Drug Administration. 2020 [cited 2020; Available from: https://www.fda.gov/drugs [database on the Internet]. Accessed: May 2020. - PubMed
  13. Drugs.com . 2020 [cited 2020; Available from: https://www.drugs.com/ [database on the Internet]. Accessed: - PubMed
  14. UpToDate. 2020 [cited 2020; Available from: www.uptodate.com. [database on the Internet]. Accessed: May 2020. - PubMed
  15. IBM Watson Micromedex. 2020 [cited 2020; Available from: https://www.micromedexsolutions.com/ . [database on the Internet]. Accessed: May 2020. - PubMed
  16. Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR. An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA. 1979;242(7):623–32. - PubMed
  17. Banda JM, Evans L, Vanguri RS, Tatonetti NP, Ryan PB, Shah NH. A curated and standardized adverse drug event resource to accelerate drug safety research. Sci Data. 2016;3:160026. - PubMed
  18. MetaMap Team. MetaMap - A Tool For Recognizing UMLS Concepts in Text. Published 2015. Accessed 4 Jun 2020. - PubMed
  19. OHDSI. OHDSI/Usagi. GitHub for OHDSI Usagi. Published 2016. Accessed 28 Jul 2020. - PubMed
  20. Caster O, Aoki Y, Gattepaille LM, Grundmark B. Disproportionality analysis for pharmacovigilance signal detection in small databases or subsets: recommendations for limiting false-positive associations. Drug Saf. 2020;43(5):479–87. - PubMed
  21. Sakaeda T, Tamon A, Kadoyama K, Okuno Y. Data mining of the public version of the FDA Adverse Event Reporting System. Int J Med Sci. 2013;10(7):796–803. - PubMed
  22. Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004;13(8):519–23. - PubMed
  23. Whitworth MM, Haase KK, Fike DS, Bharadwaj RM, Young RB, MacLaughlin EJ. Utilization and prescribing patterns of direct oral anticoagulants. Int J Gen Med. 2017;10:87–94. - PubMed
  24. Raschi E, Bianchin M, Ageno W, De Ponti R, De Ponti F. Adverse events associated with the use of direct-acting oral anticoagulants in clinical practice: beyond bleeding complications. Pol Arch Med Wewn. 2016;126(7-8):552–61. - PubMed
  25. Zhu W, He W, Guo L, Wang X, Hong K. The HAS-BLED Score for predicting major bleeding risk in anticoagulated patients with atrial fibrillation: a systematic review and meta-analysis. Clin Cardiol. 2015;38(9):555–61. - PubMed
  26. Raschi E, Bianchin M, Gatti M, Squizzato A, De Ponti F. Comparative effectiveness and safety of direct oral anticoagulants: overview of systematic reviews. Drug Saf. 2019;42(12):1409–22. - PubMed
  27. Maura G, Billionnet C, Coste J, Weill A, Neumann A, Pariente A. Non-bleeding adverse events with the use of direct oral anticoagulants: a sequence symmetry analysis. Drug Saf. 2018;41(9):881–97. - PubMed
  28. McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993–1004. - PubMed
  29. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, et al. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines and the Heart Failure Society of America. Circulation. 2017;136(6):e137–e61. - PubMed
  30. Gatti M, Antonazzo IC, Diemberger I, De Ponti F, Raschi E. Adverse events with sacubitril/valsartan in the real world: emerging signals to target preventive strategies from the FDA adverse event reporting system. Eur J Prev Cardiol. 2020:2047487320915663. - PubMed
  31. Shi V, Senni M, Streefkerk H, Modgill V, Zhou W, Kaplan A. Angioedema in heart failure patients treated with sacubitril/valsartan (LCZ696) or enalapril in the PARADIGM-HF study. Int J Cardiol. 2018;264:118–23. - PubMed
  32. McDonagh M, Peterson K, Holzhammer B, Fazio S. A systematic review of PCSK9 inhibitors alirocumab and evolocumab. J Manag Care Spec Pharm. 2016;22(6):641–53q. - PubMed
  33. Wong ND, Shapiro MD. Interpreting the findings from the recent PCSK9 monoclonal antibody cardiovascular outcomes trials. Front Cardiovasc Med. 2019;6:14. - PubMed
  34. Alonso R, Cuevas A, Mata P. Lomitapide: a review of its clinical use, efficacy, and tolerability. Core Evid. 2019;14:19–30. - PubMed
  35. Dhillon S. Macitentan: a review of its use in patients with pulmonary arterial hypertension. Drugs. 2014;74(13):1495–507. - PubMed
  36. Duggan ST, Keam SJ, Burness CB. Selexipag: a review in pulmonary arterial hypertension. Am J Cardiovasc Drugs. 2017;17(1):73–80. - PubMed
  37. Halank M, Hoeper MM, Ghofrani HA, Meyer FJ, Stahler G, Behr J, et al. Riociguat for pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: results from a phase II long-term extension study. Respir Med. 2017;128:50–6. - PubMed
  38. Lajoie AC, Bonnet S, Provencher S. Combination therapy in pulmonary arterial hypertension: recent accomplishments and future challenges. Pulm Circ. 2017;7(2):312–25. - PubMed
  39. Welch HK, Kellum JA, Kane-Gill SL. Drug-associated acute kidney injury identified in the United States Food and Drug Administration Adverse Event Reporting System Database. Pharmacotherapy. 2018;38(8):785–93. - PubMed
  40. Gray MP, Dziuba G, Quach K, Wong A, Smithburger PL, Seybert AL, et al. 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):181–5. - PubMed
  41. Arora A, Jalali RK, Vohora D. Relevance of the Weber effect in contemporary pharmacovigilance of oncology drugs. Ther Clin Risk Manag. 2017;13:1195–203. - PubMed
  42. United States Food & Drug Administration. Questions and answers on FDA’s adverse event reporting system (FAERS). Accessed Jun 2020. - PubMed

Publication Types