Evaluation of Adverse Drug Events of Remdesivir for the Treatment of COVID-19 in Patients Contacting the 13-Aban Pharmacy Drug and Poison Information Center
-
Amirhosein Ghahremanian
,
Hasti Photography
,
Sona Ghasemi
,
Mohammadreza Heidari
,
Elliyeh ghadrdan
Abstract
Background: One of the FDA-approved treatments for COVID-19 is remdesivir. In this study, we investigated adverse drug events (ADEs) of remdesivir in COVID-19 patients who contacted 13-Aban pharmacy's drug and poison information center (DPIC). Methods: In this study, data of patients receiving remdesivir who contacted the 13-Aban pharmacy's DPIC between April 2021 and May 2022 were extracted. For the evaluation of potential ADEs, we reviewed all contacts related to remdesivir recipients. Results: Out of 223 patients enrolled, 108 (48.40%) developed 120 ADEs. Elevated liver transaminase levels (26.67%) were the most common ADE, followed by weakness (7.5%), nausea, and vomiting (7.5%). The causality assessment of ADE using the Naranjo scale revealed that 41.67% were probable and 58.33% were possible. Conclusion: Based on the results of this study, hepatic dysfunction was the most prevalent ADE among remdesivir recipients; thus, in order to ensure safe use of remdesivir, patients should be closely monitored for this ADE.
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11. Gandham R, Eerike M, Raj GM, Bisoi D, Priyadarshini R, Agarwal N. Adverse events following remdesivir administration in moderately ill COVID-19 patients - A retrospective analysis. J Family Med Prim Care. 2022;11(7):3693-8.
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13. Gilead reports remdesivir helped moderately ill COVID-19 patients. Phase 3 clinical trial. Clinical Trials & Research News. Available form: https://pharmanewsintel.com/news/gilead-reports-remdesivir-helped-moderatelyill-covid-19-patients .
14. Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020;383(19):1813-26.
15. Morimoto T, Gandhi TK, Seger AC, Hsieh TC, Bates DW. Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care. 2004;13(4):306-14.
16. Bhimraj A, Morgan RL, Shumaker AH, Baden L, Cheng VC, Edwards KM,et al. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. Infectious Diseases Society of America 2023; Version 10.2.1. Available at https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management.
17. Gilead Sciences Inc. Veklury (remdesivir) compatibility with alternative diluents. https://www.askgileadmedical.com/api/rendition.php?doc=17818. Updated January 10, 2022. Accessed January 12, 2022.
2. Bashini M, Shah S, Desai C. An evaluation of adverse drug reactions with remdesivir in patients of covid-19. Asian J Pharm Clin Res. 2022;15(8):88-91.
3. Guide to the management and treatment of Covid-19 version 10-1,Corona scientific committee of the Ministry of Health and Medical Education, June 2021.
4. National Institutes of Health. COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Updated September 26, 2022. Accessed September 29, 2022.
5. Saheb Sharif-Askari F, Saheb Sharif-Askari N, Javadi M, Gholami K. Adverse drug reactions reported to the drug and poison information center of Tehran, Iran. PLoS One. 2017;12(9):e0185450.
6. Khatiwada AP, Shakya S, Shrestha S. Paradigm shift of drug information centers during the COVID-19 pandemic. Drugs Ther Perspect. 2020;36(9):389-95.
7. Spinner CD, Gottlieb RL, Criner GJ, Arribas López JR, Cattelan AM, Soriano Viladomiu A, et al. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2020;324(11):1048-57.
8. Naranjo CA, Busto U, Sellers EM. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–45.
9. Singh A, Kamath A. Assessment of adverse events associated with remdesivir use for coronavirus disease 2019 using real-world data. Expert Opin Drug Saf. 2021;20(12):1559-64.
10. Falcão F, Viegas E, Carmo I, et al. A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report. Eur J Hosp Pharm. 2021;28(5):248-53.
11. Gandham R, Eerike M, Raj GM, Bisoi D, Priyadarshini R, Agarwal N. Adverse events following remdesivir administration in moderately ill COVID-19 patients - A retrospective analysis. J Family Med Prim Care. 2022;11(7):3693-8.
12. Pires RE, Reis IGN, Waldolato GS, Pires DD, Bidolegui F, Giordano V. What Do We Need to Know About Musculoskeletal Manifestations of COVID-19?: A Systematic Review. JBJS Rev .2022;10(6).
13. Gilead reports remdesivir helped moderately ill COVID-19 patients. Phase 3 clinical trial. Clinical Trials & Research News. Available form: https://pharmanewsintel.com/news/gilead-reports-remdesivir-helped-moderatelyill-covid-19-patients .
14. Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020;383(19):1813-26.
15. Morimoto T, Gandhi TK, Seger AC, Hsieh TC, Bates DW. Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care. 2004;13(4):306-14.
16. Bhimraj A, Morgan RL, Shumaker AH, Baden L, Cheng VC, Edwards KM,et al. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. Infectious Diseases Society of America 2023; Version 10.2.1. Available at https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management.
17. Gilead Sciences Inc. Veklury (remdesivir) compatibility with alternative diluents. https://www.askgileadmedical.com/api/rendition.php?doc=17818. Updated January 10, 2022. Accessed January 12, 2022.
| Files | ||
| Issue | Vol 11, No 3 (Summer 2023) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/jpc.v11i3.15997 | |
| Keywords | ||
| Remdesivir, COVID-19, DPIC, Adverse drug events | ||
| Rights and permissions | |
|
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Ghahremanian A, Photography H, Ghasemi S, Heidari M, ghadrdan E. Evaluation of Adverse Drug Events of Remdesivir for the Treatment of COVID-19 in Patients Contacting the 13-Aban Pharmacy Drug and Poison Information Center. J Pharm Care. 2023;11(3):145-150.
