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

Charan, Jaykaran; Dutta, Siddhartha; Kaur, Rimple Jeet; Bhardwaj, Pankaj; Sharma, Praveen; Ambwani, Sneha; Jahan, Iffat; Abubakar, Abdullahi Rabiu; Islam, Salequl; Hardcastle, Timothy Craig; Rahman, Nor Azlina A; Lugova, Halyna; Haque, Mainul

doi:10.1080/14740338.2021.1946513

Cited by 36 publications

(35 citation statements)

References 55 publications

(75 reference statements)

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“…12 Literature shows that VigiBase was previously used to analyze the adverse events related to several repurposed drugs for COVID-19. [13][14][15][16] In the absence of definite post-vaccination robust data on adverse events related to the COVID-19 vaccines, most of the studies conducted on COVID-19 vaccines are based on the data generated from these vaccines' clinical trials and on the data available in the VigiBase. [17][18][19] Since all COVID-19 vaccines are new drugs; hence it is essential to monitor their adverse events post-approval.…”

Section: Introductionmentioning

confidence: 99%

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database

Kaur¹,

Dutta²,

Charan³

et al. 2021

IJGM

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Background: Thirteen COVID-19 vaccines are granted emergency approval. It is crucial to monitor their adverse events post vaccination. The present study focuses on cardiovascular adverse events post-COVID-19 vaccination and aims to determine adverse events with the administered vaccine. Methodology: The cardiovascular (CVS) adverse events were extracted for three broad headings (SOCs) -cardiac disorders, vascular disorders, and investigations. Descriptive statistics were reported in the form of percentage and frequency, and the disproportionality analysis was conducted. Results: For the cardiovascular system, 4863 adverse events (AEs) were reported from BNT162b2 Pfizer, 1222 AstraZeneca, Moderna, and other COVID-19 vaccines. Common adverse events observed with vaccines under study were tachycardia (16.41%), flushing (12.17%), hypertension (5.82%), hypotension (3.60%) and peripheral coldness (2.41%). Based on disproportionality analysis (IC 025 values), acute myocardial infarction, cardiac arrest, and circulatory collapse were linked to the vaccines in the age group >75 years. Hypertension, severe hypertension, supraventricular tachycardia, sinus tachycardia, and palpitations were associated across all age groups and either gender. Amongst the investigations, abnormal ECG findings raised C-reactive protein, elevated D dimer, and troponin were reported in specific age groups or gender or all subjects. Conclusion: Although cardiovascular events have been reported with the COVID-19 vaccines, the causality is yet to be established because such CVS AEs are also usually associated with the general public even without intervention. Hence, people should be administered these vaccines, and sustained monitoring of these AEs should be done.

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Section: Introductionmentioning

confidence: 99%

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database

Kaur¹,

Dutta²,

Charan³

et al. 2021

IJGM

Self Cite

View full text Add to dashboard Cite

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“…No successful medication has been developed yet to tackle COVID-19, and the ones in use have either no confirmatory effect rather have adverse side effects [26][27][28][29] .In this hopeless situation, physicians have used repurposed prophylaxis without knowing their exact outcomes 30 . Moreover, intensive-care-unit (ICU) requirements for ventilation have increased the chances of nosocomial infection and use of antimicrobials, resulting in antimicrobial resistance and death [31][32][33] .…”

Section: Discussionmentioning

confidence: 99%

Assessment of a rapid pan-antibody dot test for detection of antibodies against SARS-CoV-2

Haq

Jamiruddin

Khondoker

et al. 2021

Bangladesh J Med Sci

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Background: With the drastic spread of COVID-19 and mass mortality of people globally, detection of the progression of this disease has stood out to be a necessity. Hence, we set out to identify the prevalence of COVID-19 antibodies in Bangladesh using the in-house rapid pan-immunoglobulin dot-blot test kit and evaluate the performance of this kit. Methods: In this cross-sectional study, we tested serum collected between mid-May and mid-June 2020 for COVID-19 antibodies by using the in-house rapid pan-immunoglobulin dot-blot test kit in RTPCR confirmed patients with symptoms for 1-7 days (Group Ia; n =100) and 8-14 days (Group Ib; n = 100); symptomatic RT-PCR negative patients (Group II; n = 100) and convalescent patients (Group III; n = 109) while comparing with pre-pandemic sera samples collected prior two years to December-2019 (Group IV; n = 100). Results: Our kit detected that almost 70% of the convalescent patients produced antibodies against COVID-19 compared to other groups. However, the group with individuals at the end phase of COVID-19 exhibited the second-highest percentage of seroprevalence (41%). We also observed that though Group II was RT-PCR negative, 20% of them showed COVID-19 antibodies. Conclusion: With a specificity of 96% in our kit, we can say that our kit will be a potential device for the detection of SARS-CoV-2 antibodies and to understand herd immunity in Bangladesh. Bangladesh Journal of Medical Science Vol.20(5) 2021 p.131-139

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“…The research related to the COVID-19 virus is exploring mainly four arenasdissecting the virus itself, exploring the diagnostic tools, finding the prevention and the treatment modalities. Various modalities, repurposed drugs, complementary and alternative medicines, vitamins, nutraceuticals, and immune-boosters were being used to tackle the condition as there was no definitive treatment [5][6][7][8][9]. The drugs being explored for treatment include drugs like hydroxychloroquine, remdesivir, favipiravir, tocilizumab, ivermectin, baricitinib, etc.…”

Section: Introductionmentioning

confidence: 99%

“…The drugs being explored for treatment include drugs like hydroxychloroquine, remdesivir, favipiravir, tocilizumab, ivermectin, baricitinib, etc. Numerous studies were conducted to observe the safety and efficacy of these drugs in COVID-19 [6,7,[10][11][12]. As of May 19, 2021, 15 vaccines were approved for COVID-19 namely Comirnaty (BNT162b2), Moderna COVID-19 vaccine (mRNA-1273), AstraZeneca COVID-19 vaccine (AZD1222); also known as Vaxzevria and Covishield, Sputnik V, Sputnik Light, COVID-19 vaccine Janssen (JNJ-78436735; Ad26.COV2.S), CoronaVac, BBIBP-CorV, EpiVacCorona, Convidicea (Ad5-nCoV), Covaxin, WIBP-CorV, CoviVac, ZF2001, and QazVac (QazCovid-in) [13].…”

Section: Introductionmentioning

confidence: 99%

“…VigiBase is the global post-marketing pharmacovigilance database maintained by WHO, which contains the adverse events of approved drugs reported from all over the world [20]. VigiBase database had been used previously to analyze the safety profile of many drugs and vaccines including the therapies used for treatment and prevention of COVID-19 [6,7,10,11,21,22]. We evaluated all the neurological adverse events reported for COVID-19 vaccines in VigiBase.…”

Section: Introductionmentioning

confidence: 99%

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Analysis of Neurological Adverse Events Reported in VigiBase From COVID-19 Vaccines

Dutta¹,

Kaur²,

Charan³

et al. 2022

Cureus

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Background: Fifteen COVID-19 vaccines have been granted emergency approval before the completion of conventional phases of clinical trials. The present study aimed to analyze the neurological adverse events (AEs) post-COVID-19 vaccination and focuses on determining the association of AEs with the vaccine.Methodology: The neurological AEs reported for COVID-19 vaccines in the WHO pharmacovigilance database (VigiBase) were extracted from the System Organ Classes -neurological disorders and investigations. Descriptive statistics are reported as percentage and frequency and the disproportionality analysis was also conducted.Results: For the neurological system, 19,529 AEs were reported. Of these, 15,638 events were reported from BNT162b2 vaccine, 2,751 from AZD1222 vaccine, 1,075 from mRNA-1273 vaccine, eight from Vero vaccine, two from Covaxin, and for 55 AEs, vaccine name was not mentioned. The reason for more AEs reported with BNT162b2 can be maximum vaccination with BNT162b2 vaccine in the study period. According to the disproportionality analysis based on IC 025 value, ageusia, anosmia, burning sensation, dizziness, facial paralysis, headache, hypoaesthesia, lethargy, migraine, neuralgia, paresis, parosmia, poor sleep quality, seizure, transient ischemic attack, and tremor are some of the AEs that can be associated with the administration of the vaccine. Conclusion:The vaccines should be monitored for these AEs till the causality of these AEs with COVID-19 vaccines is established through further long-term follow-up studies. These neurological AEs reported in VigiBase should not be taken as conclusive and mass vaccination should be carried out to control the pandemic until a definite link of these adverse effects is established.

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

Cited by 36 publications

References 55 publications

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database

Assessment of a rapid pan-antibody dot test for detection of antibodies against SARS-CoV-2

Analysis of Neurological Adverse Events Reported in VigiBase From COVID-19 Vaccines

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