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Tocilizumab in COVID-19: a study of adverse drug events reported in the WHO database

Charan, Jaykaran and Dutta, Siddhartha and Kaur, Rimplejeet and Bhardwaj, Pankaj and Sharma, Parveen and Ambwani, Sneha and Jahan, Iffat and Abubakar, Abdullahi Rabiu and Islam, Salequl and Hardcastle, Timothy Craig and A. Rahman, Nor Azlina and Lugova, Halyna and Haque, Mainul (2021) Tocilizumab in COVID-19: a study of adverse drug events reported in the WHO database. Expert Opinion On Drug Safety, 20 (9). pp. 1125-1136. ISSN 1474-0338 E-ISSN 1744-764X

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leading to pneumonitis with a poor prognosis. Tocilizumab, a type of humanized monoclonal antibody antagonizing interleukin-6 receptors, is currently utilized to treat COVID-19. The present study reviews tocilizumab adverse drug events (ADEs) reported in the World Health Organization (WHO) pharmacovigilance database. Research design and methods: All suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients’ demographic and clinical variables, and severity of involvement of organ system. Results: A total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18–64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. ‘Injury, Poisoning, and Procedural Complications’ remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas. Conclusion: Neutropenia, superinfections, reactivation of latent infections, hepatitis, and cardiac abnormalities were common ADEs observed that necessitate proper monitoring and reporting.

Item Type: Article (Journal)
Additional Information: 5509/93893
Uncontrolled Keywords: Tocilizumab; COVID-19; adverse drug event; pharmacovigilance; WHO; monoclonal antibody; interleukin-6
Subjects: R Medicine > RS Pharmacy and materia medica > RS403 Materia Medica-Pharmaceutical Chemistry
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): Kulliyyah of Allied Health Sciences
Kulliyyah of Allied Health Sciences > Department of Physical Rehabilitation Sciences
Depositing User: Dr. Nor Azlina A Rahman
Date Deposited: 19 Nov 2021 08:33
Last Modified: 30 Jun 2022 10:25
URI: http://irep.iium.edu.my/id/eprint/93893

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