FDA retracts on use of Hydroxy-chloroquine
FDA retracts on use of Hydroxy-chloroquine The agency determined that the legal criteria for issuing an EUA are no longer met. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorised uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorised use. This is the statutory standard for issuance of an EUA, says an FDA press release on Monday. The Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services originally requested the EUA covering chloroquine and hydroxychloroquine, and the FDA granted the EUA on March 28, 2020 based on the science and data available at the time. Today, in co...