The U.S. Food and Drug Administration Monday revoked emergency use authorization for a malaria drug that President Donald Trump hailed as a successful treatment for COVID-19.
The FDA said there is growing evidence that hydroxychloroquine along with another malaria drug, chloroquine, are unlikely to be effective in treating the coronavirus and could cause deadly side effects.
The agency said the drugs' unproven benefits “do not outweigh the known and potential risks.”
Several recent studies have suggested the drugs are not effective in combating COVID-19 and can cause complications, including heart rhythm problems, low blood pressure, and even death.
The FDA’s decision means that federal supplies of the drug will no longer be distributed to state and local health officials to use against the coronavirus. Doctors can still use hydroxychloroquine to treat other health problems, including malaria, lupus and rheumatoid arthritis.
The president of the Infectious Disease Societies, Dr. Thomas File, says he supports Monday's FDA action.
“As our body of knowledge expands in response to the COVID-19 pandemic, our nation must remain committed to following the science and ensuring policies that protect the health of residents as we investigate effective treatments to counter this insidious virus,” File said.
Early in the coronavirus outbreak, Trump said he believed hydroxychloroquine along with the antibiotic azithromycin, had a “real chance” to be “game changers” in fighting COVID-19, the disease cause by the coronavirus. He later said he took the drugs himself and is healthy.