The United States Food and Drug Administration (FDA) warned against taking anti-malarial drug hydroxychloroquine, touted by President Donald Trump as a possible treatment for COVID-19, outside of a hospital or formal study on Friday, citing "serious and potentially life-threatening heart rhythm problems".
Trump has repeatedly stated that the drug is a possible treatment for COVID-19 and could be a "game-changer", seemingly based on anecdotal evidence.
No conclusive tests have been completed to prove its effectiveness.
FDA Commissioner Dr Stephen M Hahn said in a statement: "We understand that healthcare professionals are looking for every possible treatment option for their patients and we want to ensure we're providing them with the appropriate information needed for them to make the best medical decisions.
"While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered."
Pending approval
Trump said at an April 4 news briefing regarding hydroxychloroquine: "What do you have to lose? Take it."
The president has hedged these remarks by saying people should confer with their doctors.
Hydroxychloroquine and chloroquine, a similar drug, are approved by the FDA to treat malaria and other ailments.
Once a drug is approved by the FDA, the release explained, it may be prescribed for unapproved uses by doctors, depending on a physician's assessment.
The drugs have been approved for purchase and addition to the Strategic National Stockpile and may be prescribed by doctors for the treatment of COVID-19 when clinical trials are not available or feasible.
But the medicines "have not been proven safe or effective for treating COVID-19", the FDA said in its release.
"We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks," Hahn said.
"The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available."
SOURCE: Al Jazeera and news agencies
