Analysis of Favipiravir Adverse Drug Reactions during COVID-19 Pandemic: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database

Yasir Ezalden Noori Alkashab; Inam S. Arif; Manal M. Younus; Mohammed M. Mohammed; Abdullah M. Alrawi; Salim Hamadi

doi:10.32947/ajps.v24i2.1069

Authors

Yasir Ezalden Noori Alkashab University of Mustansiriyah / College of Pharmacy
Inam S. Arif Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq
Manal M. Younus Iraqi Pharmacovigilance Center, Ministry of Health, Baghdad, Iraq
Mohammed M. Mohammed Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq
Abdullah M. Alrawi BS Pharm, Mustansiriyah university
Salim Hamadi department of pharmacology &Biomedical sciences, university of petra Amman Jordan

DOI:

https://doi.org/10.32947/ajps.v24i2.1069

Keywords:

COVID-19, SARS-COV-2, Favipiravir, coronavirus, pharmacovigilance, Iraq, Adverse events

Abstract

The “severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)” was the reason behind the recent pandemic “COVID-19” that started from Wuhan, china, and rapidly spread to many regions of the world. Research in Drug repurposing processes to treat this novel coronavirus involved many medications,

one of the most discussed is Favipiravir. The objective of the current work was aimed towards Examining the cause, severity, preventability, predictability, and outcome of favipiravir-associated adverse events that had been reported in Iraq. In terms of adverse drug responses, "Gastrointestinal disorders" accounted for the majority (57.4%), followed by "Cardiac disorders" (35.2%), and "Investigations" (abnormal lab test results) (13%). The causality of these reactions Is majorly “Possible” (62%). Severity level 1 (40.9%) and 2 (41.8%). Ninety-nine percent of the ADRs are expected. The majority of the ADRs are non-Preventable (76.3%). The main outcome is Recovered / Resolved (44.5%). About (50%) of the ADRs were serious.

References

Organization WH. Coronavirus disease (COVID-19) pandemic, https://www.who.int/emergencies/diseases/novel-coronavirus-2019 (2019, accessed 16th of August 2023).

H S, S R and TN L. Severity and Risk of Death Due to COVID 19. Al Mustansiriyah Journal of Pharmaceutical Sciences 2020; 20: 1-12. DOI: https://doi.org/10.32947/ajps.v20i4.769

Li G and De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nat Rev Drug Discov 2020; 19: 149-150. DOI: 10.1038/d41573-020-00016-0. DOI: https://doi.org/10.1038/d41573-020-00016-0

Furuta Y, Takahashi K, Fukuda Y, Kuno M, Kamiyama T, et al. In vitro and in vivo activities of anti-influenza virus compound T-705. Antimicrob Agents Chemother 2002; 46: 977-981. DOI: 10.1128/aac.46.4.977-981.2002. DOI: https://doi.org/10.1128/AAC.46.4.977-981.2002

Baranovich T, Wong SS, Armstrong J, Marjuki H, Webby RJ, et al. T-705 (favipiravir) induces lethal mutagenesis in influenza A H1N1 viruses in vitro. J Virol 2013; 87: 3741-3751. 20130116. DOI: 10.1128/jvi.02346-12. DOI: https://doi.org/10.1128/JVI.02346-12

Vanderlinden E, Vrancken B, Van Houdt J, Rajwanshi VK, Gillemot S, et al. Distinct Effects of T-705 (Favipiravir) and Ribavirin on Influenza Virus Replication and Viral RNA Synthesis. Antimicrob Agents Chemother 2016; 60: 6679-6691. 20161021. DOI: 10.1128/aac.01156-16. DOI: https://doi.org/10.1128/AAC.01156-16

Wang M, Cao R, Zhang L, Yang X, Liu J, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Research 2020; 30: 269-271. DOI: 10.1038/s41422-020-0282-0. DOI: https://doi.org/10.1038/s41422-020-0282-0

Aronson JK and Ferner RE. Clarification of terminology in drug safety. Drug Saf 2005; 28: 851-870. DOI: 10.2165/00002018-200528100-00003. DOI: https://doi.org/10.2165/00002018-200528100-00003

User Guide. VigiFlow5.2. the Uppsala Monitoring Centre.

Belhekar MN, Taur SR and Munshi RP. A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions. Indian J Pharmacol 2014; 46: 117-120. DOI: 10.4103/0253-7613.125192. DOI: https://doi.org/10.4103/0253-7613.125192

Hartwig SC, Siegel J and Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992; 49: 2229-2232. DOI: https://doi.org/10.1093/ajhp/49.9.2229

Petrova G, Stoimenova A, Dimitrova M, Kamusheva M, Petrova D and Georgiev O. Assessment of the expectancy, seriousness and severity of adverse drug reactions reported for chronic obstructive pulmonary disease therapy. SAGE Open Med 2017; 5: 2050312117690404. 20170131. DOI: 10.1177/2050312117690404. DOI: https://doi.org/10.1177/2050312117690404

Schumock GT and Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992; 27: 538.

N YA, S I, M M and MM M. Analysis of Azithromycin adverse events in COVID-19 Patients reported to Iraqi Pharmacovigilance center in 2020. Al Mustansiriyah Journal of Pharmaceutical Sciences 2022; 22: 35-42. DOI: https://doi.org/10.32947/ajps.v22i3.887

Ergür F, Yıldız M, Sener M, Kavurgacı S and Öztürk A. Adverse effects associated with favipiravir in patients with COVID-19 pneumonia: a retrospective study. Sao Paulo Medical Journal 2022; 140. DOI: 10.1590/1516-3180.2021.0489.r1.13082021. DOI: https://doi.org/10.1590/1516-3180.2021.0489.r1.13082021