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 consultation with the FDA, BARDA sent a letter to the FDA requesting revocation of the EUA based on up to date science and data.

“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” said FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, MD.

“The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorisations the FDA has issued and make changes, as appropriate, based on emerging evidence.”

lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews lcountrybreakingnews