| ORIGINAL RESEARCH ARTICLE
|Year : 2022 | Volume
| Issue : 6 | Page : 417-422
Pharmacovigilance study of amphotericin B for mucormycosis in post-COVID and non-COVID patients at a tertiary care hospital in Eastern India
Suparna Chatterjee1, Manjari Bhattacharjee1, Avijit Hazra1, Pradip Mukhopadhyay2, Biman Kanti Ray3, Sayan Chatterjee1, Souvik Dubey4
1 Department of Pharmacology, Institute of Postgraduate Medical Education and Research, West Bengal, India
2 Department of Endocrinology and Metabolism, Institute of Postgraduate Medical Education and Research and SSKM Hospital, West Bengal, India
3 Department of Neuromedicine, Bangur Institute of Neurosciences (Under Institute of Postgraduate Medical Education and Research), Kolkata, West Bengal, India
4 Department of Neuromedicine, Bangur Institute of Neurosciences (Under Institute of Postgraduate Medical Education and Research and SSKM Hospital), Kolkata, West Bengal, India
BACKGROUND: Mucormycosis is a rare but serious fungal infection which has dramatically increased in post-COVID patients. There is a paucity of safety data on amphotericin B (amphoB) used for mucormycosis treatment.
OBJECTIVES: The objective of this prospective, observational, active safety surveillance study was to evaluate the safety profile of amphoB in a cohort of hospitalized patients who were on the drug for suspected mucormycosis.
MATERIALS AND METHODS: All suspected adverse drug reactions (ADRs) in hospitalized mucormycosis patients who had received amphoB were analyzed. The nature, severity, outcome of the ADRs were recorded and analyzed.
RESULTS: Of the 77 patients enrolled, 70% had documented history of prior COVID-19 infection. 96% had comorbidities, the most common being diabetes. Majority received conventional amphotericin B deoxycholate formulation. 97% experienced at least one suspected ADR and the median ADR/patient was 3. Out of 214 ADRs, 91 were serious but there were no ADR-related deaths. The most common ADRs were hypokalemia (31.78%), infusion-related reactions (22.43%), and anemia (17.29%). Thirty-three patients had serum potassium <2.5 mEq/L, while 11 had serum magnesium <1.25 mg/dL. Doubling of pretreatment creatinine level was noted in 15 patients. Seventy percent ADRs were of “possible” category as per the World Health Organization Uppsala Monitoring Centre categorization.
CONCLUSION: AmphoB deoxycholate use in mucormycosis patients was associated with a high incidence of electrolyte abnormalities and infusion-related reactions. All ADRs subsided with medical management and none were fatal. The safety data generated from this study may be useful in resource-limited settings where the far more expensive liposomal formulation is not being used.
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, 244B, AJC Bose Road, Kolkata - 700 020, West Bengal
Source of Support: None, Conflict of Interest: None
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