Adverse drug reaction profile of prophylactic hydroxychloroquine for COVID-19 among doctors

Abstract

Background: Recently, hydroxychloroquine (HCQ) has been advocated by the Indian Council of Medical Research for prophylaxis of COVID-19, and the Food and Drug Administration has given emergency use authorization for its use in the treatment of severe COVID-19 disease in hospitalized patients. HCQ is generally well tolerated; however, concerns about adverse effects in adults prescribed with HCQ for prophylaxis remain. Our study was designed to investigate the adverse drug reaction (ADR) profile of HCQ in prophylactic doses for COVID-19 prophylaxis among doctors. Materials and Methods: This was a cross-sectional study carried out among doctors taking HCQ prophylaxis for COVID-19. The study was carried out over 1 month from April 1, to April 30, 2020. Data regarding age, sex, comorbidities, number of doses taken, concomitant drug therapy, adherence to drug schedule, need for treatment of ADRs, and possible adverse effects were obtained from the patients. The participants were administered an online pretested, validated questionnaire to ascertain the adverse effects they noticed while taking HCQ. Results: One-hundred and forty doctors were included in the study group. Sixty-nine adverse events were documented in 44 participants (31%). The most frequently reported symptoms were headache followed by nausea, dizziness, abdominal cramps, and loose stools. Hypoglycemia was seen in three participants, all with diabetes. Sixteen participants required medication to treat the adverse effects (most commonly ibuprofen for headache), while four participants discontinued the drug due to adverse effects (two each because of hypoglycemia and one each because of nausea and loose stools). There was no statistically significant difference of age, gender, number of doses taken, or comorbidities on adverse effects. Conclusion: Almost a third of the participants reported adverse effects. Utmost care is necessary before using HCQ prophylactically for chemoprophylaxis of COVID-19.