Pharmacovigilance study of amphotericin B for mucormycosis in post-COVID and non-COVID patients at a tertiary care hospital in Eastern India.
Indian J Pharmacol
; 54(6): 417-422, 2022.
Article
in English
| MEDLINE | ID: covidwho-2225965
ABSTRACT
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 ANDMETHODS:
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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Drug-Related Side Effects and Adverse Reactions
/
COVID-19
/
Mucormycosis
Type of study:
Cohort study
/
Experimental Studies
/
Observational study
/
Prognostic study
Topics:
Long Covid
Limits:
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Indian J Pharmacol
Year:
2022
Document Type:
Article
Affiliation country:
Ijp.ijp_474_22
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