HYDERABAD: The US Food and Drug Administration (USFDA) warned healthcare providers against co-administration of Gilead Sciences remdesivir, which received emergency use authorization for COVID-19 patients, along with chloroquine phosphate or hydroxychloroquine sulfate as it may reduce the efficacy of the former.
The FDA said though the agency is not aware of instances of this reduced activity occurring in the clinical setting but, is continuing to evaluate all data related to remdesivir.
“FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a statement.
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Following an evaluation of the emergency use authorization criteria and scientific evidence available, the FDA issued an emergency use authorization (EUA) in May 2020 allowing remdesivir to be distributed in the US to treat COVID-19 in adults and pediatric patients hospitalised with severe disease.
The safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, and preliminary clinical trial results have shown that on average, patients treated with remdesivir had more rapid time to recovery.
The Health Ministry on June 13 recommended the use of antiviral drug remdesivir in moderate stage of COVID-19 while backtracking from its earlier stance on hydroxychloroquine, saying the anti-malarial drug should be used in the early course of the disease and not on critically ill patients.
Some of the Indian drug makers including Dr Reddys, Hetero, Jubilant Life Sciences and Cipla — with which the original drug maker Gilead Sciences Inc have entered into non-exclusive licensing agreements are still awaiting the nod from DCGI for manufacturing and selling remdesivir in India.