Safety of Hydroxychloroquine use for COVID-19 prophylaxis: A questionnaire-based pilot study in healthcare professionals

Hydroxychloroquine (HCQ) was recommended for prophylaxis against SARS-COV-2 for the health care professionals by the Indian Council for Medical Research. We conducted this study to explore the safety of Hydroxychloroquine in health care professionals. A validated questionnaire was circulated electronically to the health care professionals, who were on HCQ as per ICMR recommended regimen. Questions on specific adverse drug reactions (ADRs) were asked along with other details. The participants were requested to upload the baseline and additional electrocardiograms (ECGs) taken during HCQ prophylaxis. Incidence, severity, causality (relatedness to the drug), expectedness, and seriousness of the ADRs were determined as per the standard guidelines. The ECGs were evaluated for the appearance of significant changes. The observations were analyzed through descriptive statistics. The ECG changes were compared using the Students t-test and the association of risk factors with the ADRs was evaluated using logistic regression analysis. ADRs were observed in 58 (46 %) of 126 participants. Gastrointestinal symptoms followed by headache and skin rashes were commonly observed. The ADRs were mostly mild to moderate in the category, non-serious, and possibly related to HCQ. Significant ECG changes were rare. Diabetes, hypertension, and the use of concomitant medication/s were the risk factors. Except for blurred vision, all the ADRs were unexpected in terms of frequency. HCQ causes non-specific ADRs of mild to moderate degrees when used as prophylaxis. Though non-serious, almost all were unexpected. ECG changes are probably not frequent in the absence of a pre-existing disease.

Spontaneous cardiac tamponade associated with dabigatran use in an elderly woman

We report here a rare case of dabigatran-related spontaneous cardiac tamponade, which appeared in absence of the known risk factors that predispose the patient to bleed related to anticoagulant drugs. A 65-year-old lady presented to the emergency room with sudden onset dyspnea which woke her up in the early morning hours. Four days earlier, she had been started on dabigatran therapy for DVT. On examination, she was in shock. Transthoracic echocardiography confirmed cardiac tamponade. Emergent pericardiocentesis was done, draining 480 ml of haemorrhagic fluid, which tested negative for microbes and malignant cells. The patient recovered rapidly and fluid did not re-accumulate after withdrawal of dabigatran therapy. Spontaneous cardiac tamponade is rare with the use of direct anticoagulants, especially dabigatran, in the absence of predisposing risk factors. This case study highlights the need for clinicians to be cognizant of this potentially life-threatening adverse drug reaction of dabigatran so that appropriate timely action can be taken toward diagnosis and management of this complication.