The FDA updated its fact sheet on the co-administration of remdesivir with chloroquine phosphate or hydroxychloroquine.
The FDA released a warning to health care providers concerning an update on potential drug reactions for remdesivir, an antiviral drug that is being evaluated as a potential treatment for the novel coronavirus disease 2019 (COVID-19) and has also been granted emergency use authorization (EUA) status for treating hospitalized patients with severe COVID-19.
The FDA is also revising their fact sheet for health care providers to include the warning that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate may result in less effective antiviral activity of remdesivir. The revised fact sheet also clarifies dosing and administration recommendations, and will provide additional safety data and updates from clinical trials from the National Institutes of Health (NIH) and Gilead Sciences, Inc, the company that sponsors the drug and has donated 607,000 vials of remdesivir to the United States government.
Related: FDA Revokes EUA for Chloroquine and Hydroxychloroquine
Early this month, Gilead released the results of their phase 3 SIMPLE trial, which found that 5-day treatment with remdesivir in hospitalized patients with COVID-19 experienced greater clinical symptom improvement compared with standard of care.
The agency’s latest warning is based on a completed non-clinical study. Patrizia Cavazzoni, MD, acting director of the FDA Center for Drug Evaluation and Research, asserted that the FDA continues to prioritize the safety of Americans amid a rapidly-developing situation.
“Over the course of this unprecedented pandemic, the FDA has issued emergency use authorizations for a variety of medical products after evaluating the available scientific evidence and carefully balancing any known or potential risks against the benefits of making these products available during the current public health emergency. We understand that, 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,” she said. “As we have done throughout the pandemic, the FDA continues to evaluate all of the emergency use authorizations issued and their related materials and will continue to make changes as appropriate based on emerging science and data.”
1. Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use. News Release. FDA; June 15, 2020. Accessed June 15, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19....