Hydroxychloroquine as Therapeutic Option in COVID-19: Analysis of Suspected Cardiovascular Adverse Drug Events Reported in the VigiBase

Authors

  • Siddhartha Dutta Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India
  • Rimplejeet Kaur Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India
  • Pankaj Bhardwaj Department of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India
  • Surender Deora Department of Cardiology, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India
  • Kavita Singh Centre for Chronic Conditions & Injuries (CCCI), Public Health Foundation of India, Gurugram, National Capital Region, India
  • Sneha Ambwani Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India
  • Jaykaran Charan Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India
  • Abdullahi Rabiu Abubakar Lecturer, Department of Pharmacology and Therapeutics, Faculty of Pharmaceutical Sciences, Bayero University, Kano. Postcode: 700233. P.M.B., 3452, Kano, Nigeria
  • Iffat Jahan Department of Physiology, Eastern Medical College, Cumilla, Bangladesh
  • Halyna Lugova Department of Community Medicine, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia, Kem Perdana Sungai Besi, 57000 Kuala Lumpur, Malaysia
  • Salequl Islam Department of Microbiology, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh
  • Mainul Haque The Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, Malaysia

DOI:

https://doi.org/10.3329/bjms.v20i4.54150

Keywords:

Hydroxychloroquine; COVID-19; SARS-COV2; Azithromycin; Cardiovascular; Adverse Events.

Abstract

Background: Hydroxychloroquine(HCQ), one of the repurposed drugs in COVID-19, has several known cardiovascular(CVS) toxicities.

Methods: VigiBase data were used to analyze the reported ADEs linked to HCQ. The data were analyzed based on age, gender, and seriousness of ADEs at the System Organ Classification level and the individual Preferred Term level.

Results: The majority were above 18 years(91.6%) and from Europe(41.6%). A total of 5,315 ADEs were associated with HCQ use in COVID-19. Of these, 918 ADEs were attributed to CVS and reported from 773 patients. Grossly, CVS ADEs were associated with concomitant use of HCQ and azithromycin(AZM), and only 40 ADEs were solely due to HCQ. The majority were serious (69.3%) and resolved afterward (51%). In CVS ADEs, there were 366 cardiac disorders, 38 vascular disorders, and 514 ADEs under investigation. Among the cardiac disorders, palpitation was the most typical (N=65), followed by bradycardia(N=44) and tachycardia(N=33). Among arrhythmias, QT prolongation (N=469), atrial fibrillation (N=25), and ventricular tachycardia(N=16) were common. The odds of developing serious CVS ADEs increased with age, patients aged 45-64 years(OR=1.75; p= 0.015) and >65 years(OR=1.93, p=0.003) as compared to younger ones.

Conclusion: Hydroxychloroquine with known CVS toxicities and increased risk with co-administering AZM makes physicians cautious while prescribing in COVID-19 patients.

Bangladesh Journal of Medical Science Vol.20(4) 2021 p.897-910

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Published

2021-06-18

How to Cite

Dutta, S., Kaur, R., Bhardwaj, P., Deora, S., Singh, K., Ambwani, S., Charan, J., Abubakar, A. R., Jahan, I., Lugova, H., Islam, S., & Haque, M. (2021). Hydroxychloroquine as Therapeutic Option in COVID-19: Analysis of Suspected Cardiovascular Adverse Drug Events Reported in the VigiBase. Bangladesh Journal of Medical Science, 20(4), 897–910. https://doi.org/10.3329/bjms.v20i4.54150

Issue

Vol. 20 No. 4 (2021)

Section

Original Articles

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