The US Food and Drug Administration (FDA) has warned against using the anti-malaria drug hydroxychloroquine on coronavirus patients outside of hospital settings or clinical trials.
President Donald Trump has hailed the drug, which also is used to treat arthritis and lupus, as a ‘game-changer’ for treating COVID-19, the disease caused by the virus.
The federal health agency said it was issuing the warning after several reports of abnormal heart rhythms and rapid heart rates in patients who took the medication.
‘The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin,’ the FDA wrote in a statement issued on Friday.
‘We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.’
The warning comes as it’s revealed that President Trump’s aides launched a huge behind-the-scenes effort to hydroxychloroquine as a treatment for the new virus.
The FDA issued a statement warning doctors against using hydroxychloroquine (pictured) on coronavirus patients outside of hospital settings or clinical trials
President Donald Trump has touted the drug in as a potential ‘game-changer’ for treating coronavirus. Pictured: Trump during the White House coronavirus daily briefing, April 23
The agency said hydroxychloroquine can still be used in clinical trials or in some hospitalized patients.
It’s not immediately clear if any trials are in progress or planned trials will be halted based on the new guidance.
President Trump was among the first to wax lyrical about the possible benefits of hydroxychloroquine for coronavirus patients last month.
‘This would be a gift from heaven, this would be a gift from God if it works,’ he said during a press conference. ‘We are going to pray to God that it does work.’
He then repeated the claims on Twitter.
‘HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents),’ he wrote in March.
The study Trump refers to comes from Marseille, France, in which 30 patients were treated with hydroxychloroquine for 10 days combined with azithromycin, an antibiotic.
The FDA made its warning after several reports of abnormal heart rhythms and rapid heart rates in patients who took the medication. Pictured: Medics prepared to intubate a patient with COVID-19 symptoms at home
Although very small, the study ‘showed a significant reduction of the viral carriage’ after the six days and ‘much lower average carrying duration’ compared to patients who received other treatments.
One week later, the FDA issued an emergency use authorization for the drug, saying it could be used in hospitalized coronavirus patients with severe disease.
Several weeks later, the French study’s publisher said the paper ‘did not meet its standards’ because it excluded data on patients who did not respond well to the treatment.
Since then, much of the initial excitement surround hydroxychloroquine has died down.
In one study from the National Institutes of Health, 28 percent of US veterans with coronavirus who were treated with hydroxychloroquine died of the infection.
About 22 percent of those getting the anti-malaria drug plus antibiotic azithromycin died as well.
Additionally, the family of a New York woman with symptoms of COVID-19 told NBC News she died after her doctor prescribed her a combination of hydroxychloroquine and azithromycin.
The family says the physician did not confirm she had the virus nor test for heart problems before prescribing the drug.
And, earlier this month, the Centers for Disease Control and Prevention (CDC) removed highly unusual guidance from its website informing doctors on how to prescribe hydroxychlorquine.
Initially, the CDC webpage had read: ‘Although optimal dosing and duration of hydroxychloroquine for treatment of COVID-19 are unknown, some US clinicians have reported anecdotally.’
Now the website no longer includes that information. Instead, its first sentence says: ‘There are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19.’