FDA warns of potential drug interaction with remdesivir
Hours after revoking its emergency use authorization (EUA) for hydroxychloroquine and chloroquine to treat coronavirus disease (COVID-19), the US Food and Drug Administration (FDA) is now warning that the drugs could interact with Gilead Sciences’ remdesivir, potentially reducing its antiviral activity.Remdesivir, also authorized under an EUA, is now the only drug with emergency authorization to treat COVID-19 in the US. (RELATED: FDA revokes EUA for hydroxychloroquine, chloroquine, Regulatory Focus 15 June 2020; FDA authorizes Gilead’s remdesivir for emergency use, Regulatory Focus 1 May 2020).
“Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies [remdesivir] to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity,” FDA says, noting that it is not aware of any instances of this occurring in clinical settings.
“As we learn more about these products, changes may be necessary based on new data – such as today’s updates for health care providers about a potential drug interaction and other important information about using remdesivir to treat COVID-19 patients,” said Patrizia Cavazzoni, acting director of FDA’s Center for Drug Evaluation and Research.
FDA also says it has updated its fact sheets for health care providers to include the potential drug interaction with hydroxychloroquine and chloroquine and to clarify dosing and administration recommendations. Additionally, FDA says it updated the fact sheet for patients and caregivers to include an allergy warning and to instruct patients to inform their health care providers if they are taking hydroxychloroquine or chloroquine.