June 15 (UPI) -- Citing safety and efficacy concerns, the Food and Drug Administration on Monday withdrew Emergency Use Authorization for two drugs that were promoted by President Donald Trump as possible COVID-19 treatments.
FDA Chief Scientist Denise Hinton said the agency will no longer allow the anti-malaria drugs hydroxychloroquine and chloroquine to be prescribed to hospitalized coronavirus patients, or allow them to be used in clinical trials via an emergency authorization it gave in March.
Hinton said results from recent trials have shown the two drugs are "unlikely to be effective in treating COVID-19."
"Recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of [hydroxychloroquine] treatment in hospitalized patients with COVID19," she wrote in a letter to Dr. Gary Disbrow, director of medical countermeasures programs at the Biomedical Advanced Research and Development Authority.
Hinton also cited "ongoing serious cardiac adverse events and other serious side effects" as a reason to discontinue authorization for the drugs.
"The known and potential benefits of [hydroxychloroquine and chloroquine] no longer outweigh the known and potential risks for the authorized use."
Early observations saw some decreased viral activity in coronavirus patients who'd taken hydroxychloroquine and chloroquine, but Hinton said they "have not been consistently replicated."
Early during the pandemic, Trump had noted the drugs as potential weapons against the coronavirus disease. Some critics said the FDA's decision to authorize the drugs for emergency use was spurred by political pressure.
Last week, researchers also said hydroxychloroquine showed no potential benefit as a COVID-19 treatment. Dr. Anthony Fauci, an infectious diseases expert and part of Trump's coronavirus task force, said last month the drug is ineffective against the pandemic.
World moves to reopen amid COVID-19 pandemic
New York Gov. Andrew Cuomo (L) passes out face masks when he arrives at Grand Central Station to attend a nearby press conference to enter phase 1 of a four-part reopening plan in New York City on June 8. Photo by John Angelillo/UPI | License Photo