The U.S. Food and Drug Administration (FDA) cautioned Friday against the use of malaria drug hydroxychloroquine in COVID-19 patients even as President Donald Trump, who has touted it as a “game-changer,” advocated for an additional review.
Modi Proposes, Trump Disposes
The FDA said it was aware of increased use of hydroxychloroquine and chloroquine through outpatient prescriptions and that the malaria drugs could cause abnormal heart rhythms and dangerously rapid heart rate.
The agency also took note of the information from other research teams, such as the study presented in Marseille, France, which claimed that hydroxychloroquine and the antibiotic azithromycin had been successful in treated patients.
According to the FDA, studies like this lack veracity because they are too small or poorly designed to offer strong evidence of benefit, representing a high risk.
The FDA’s announcement comes a day after the European Union’s drug regulator warned of the side effects of the drugs, urging medical professionals to monitor patients on the medicines closely.
The agency has allowed healthcare providers to use the drugs for COVID-19 through its emergency use authorization but has not approved them to treat the disease.
The heart rhythm risks may increase when the medicines are combined with other drugs, such as antibiotic azithromycin, as well as in patients with existing heart and kidney disease, the agency said.
COVID-19, the disease caused by the new coronavirus, has no approved treatment or vaccine so far. But hydroxychloroquine has been widely used in an attempt to alter the course of the COVID-19 illness based on anecdotal reports that it may provide some benefit, albeit none with the necessary accuracy.
Meanwhile, President Donald Trump continues his insistence that the drug could be a good option to fight the virus.