COVID-19 FDA NEWS RELEASES
- FDA revokes the emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate to treat certain hospitalized patients with COVID-19
FDA revoked the EUA that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine were unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of observed serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweighed the known and potential risks for the authorized use. To learn more, go to:
- FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use
FDA is warning health care providers about a potential drug interaction related to the investigational antiviral drug remdesivir, which has received (EUA) for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended, as it may result in reduced antiviral activity of remdesivir. To learn more, go to:
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