The FDA said the anti-malaria drugs were “unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.”
“Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use,” the FDA wrote.
The agency had initially given an emergency use authorization for the drugs in March. This implied that doctors could use the medication on patients hospitalized with the coronavirus despite the drugs not having been formally approved.
A month later, the agency was warning people against taking the drugs outside a hospital or formal clinical trial setting due to the risk of “serious heart rhythm problems."
Besides treating malaria, hydroxychloroquine is also used in the treatment of rheumatoid arthritis and lupus. However, it is unfortunately associated with serious side effects such as heart arrhythmia.
In addition, although clinical trials are investigating its effectiveness in fighting COVID-19, it so far has not been proven.
To make matters worse a recent study from the New England Journal of Medicine found the drug was no better than a placebo in preventing COVID-19 infection. Despite that, people worldwide have been taking it after a few small studies suggested it could help.
U.S. President Donald Trump promoted the drug, disclosing last month that he was taking it daily to prevent infection. He even had his White House physician release a memo stating that “the potential benefit from treatment outweighed the relative risks."