Silver Spring, MD – The U.S. Food and Drug Administration is continuing to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
Today, FDA revoked the emergency use authorization (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 Coronavirus 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 are unlikely to be effective in treating COVID-19 Coronavirus for the authorized 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 authorized use. The agency issued a Press Release and posted FAQs about this action.
Today, FDA is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 Coronavirus 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. The agency issued a Press Release about this action.
On June 12th, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia.
The FDA recognizes the increased demand for certain products during the COVID-19 Coronavirus public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
To learn more about keeping your pets safe during the COVID-19 Coronavirus pandemic, watch this new video.
To date, the FDA has authorized 138 tests under EUAs, which include 117 molecular tests, 20 antibody tests, and 1 antigen test.
- FAQs on Testing for SARS-CoV-2
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
- Coronavirus Disease 2019 (COVID-19)
Consumer Inquiries: 888.INFO.FDA
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.