Title:Hydroxychloroquine: Adverse Drug Reaction Profile of an Old Drug in a
New Situation
Volume: 17
Issue: 4
Author(s): Deepti Chopra, Bharti Bhandari*, Jayant Rai, Rashmi Upadhyay, Jaspreet Kaur Sidhu and Saurabh Srivastava
Affiliation:
- Department of Physiology,
Government Institute of Medical Sciences, Greater Noida, India
Keywords:
COVID-19, ADRs, hydroxychloroquine, prophylaxis, HCQ, healthcare professionals.
Abstract:
Background: Hydroxychloroquine (HCQ) has been extensively used during the
COVID-19 pandemic both as a therapeutic and prophylactic drug. HCQ is generally well tolerated;
however, adverse drug reactions (ADRs) in COVID-19 need further exploration. In this study, we
have determined the type and pattern of ADRs of HCQ as a prophylactic and therapeutic drug in
COVID-19.
Methods: All spontaneous suspected ADR reports due to HCQ in COVID-19 patients submitted to
the ADR monitoring of a tertiary care hospital were included. Additionally, a survey was designed
for active surveillance of ADRs among healthcare professionals (HCPs) who were on prophylaxis
with HCQ. The ADRs were analyzed to determine severity, causality, and preventability using the
Hartwig Scale, World Health Organisation-Uppasala Monitoring Centre (WHO–UMC) scale, and
modified Schumock and Thornton criterion respectively.
Results: Sixty-four ADR reports were received from COVID-19 patients. A total of 78 ADRs were
reported by 49 HCPs who were on HCQ prophylaxis. The majority of the patients had ADRs related
to skin and soft tissues (37.5%), whereas the HCPs on prophylaxis mostly had gastrointestinal
complaints (42.3%). ADRs observed in HCPs on prophylaxis were mild, not requiring any intervention.
However, 50% of ADRs in patients were of “moderate” category.
Conclusion: Undiscerning and unsupervised use of HCQ can expose the general population as
well as patients to serious adverse drug effects. Utmost care is necessary before using HCQ
prophylactically or for treatment in COVID-19.