On Friday, President Donald Trump announced that chloroquine and hydroxychloroquine, which are anti-malarial drugs, have shown “very encouraging results” in treating the new coronavirus, aka COVID-19.
He claimed that the medications have “gone through the approval process” and that “we’re going to be able to make that drug available almost immediately.”
However, the U.S. Food and Drug Administration (FDA) has issued a statement clarifying that these anti-malarial drugs are not approved for the treatments of COVID-19.
The agency said these drugs are approved to treat and prevent malaria, lupus, and rheumatoid arthritis and they should be clinically assessed before the approval.
FDA Commissioner Dr. Stephen Hahn said, “We understand and recognize the urgency with which we are all seeking prevention and treatment options for COVID-19. FDA staff are working expeditiously on that front,”
“We also must ensure these products are effective; otherwise we risk treating patients with a product that might not work when they could have pursued other, more appropriate, treatments,” he added.
Referring to a 2005 study that appeared in the journal Virology. Dr. Len Horovitz from Lenox Hill Hospital, NYC, said the report raised a possibility that chloroquine and hydroxychloroquine could be used for treating COVID-19.
The study revealed that chloroquine could help prevent the spread of the coronavirus, which caused severe acute respiratory syndrome (SARS) in 2002-03, in primate cells grown in culture.
It was found that chloroquine blocks a critical step that is associated with the coronavirus on a cellular level.
Last month, a research team led by virologist Manli Wang of the Chinese Academy of Sciences found that chloroquine successfully blocked the spread of COVID-19 in cultured human cells.
In addition, some preliminary reports from China, South Korea, and France have suggested that the drug is at least somewhat effective in treating COVID-19.
In fact, some hospitals in the United States have started using the drug to treat the new virus, according to The New York Times. Besides, the FDA has been organizing a large human trial to officially assess chloroquine’s effects.
Wang’s team also studied the effects of hydroxychloroquine, and like chloroquine, it also prevented the replication of the new coronavirus. The researchers published their findings Wednesday in the journal Cell Discovery.
In the United States, researchers from the University of Minnesota are studying whether hydroxychloroquine could help protect people from getting infected by the COVID-19.
There has been a shortage in both chloroquine and hydroxychloroquine supply since earlier this month. However, on Thursday, Bayer donated more than 3 million tablets to the federal government, while Teva, Novartis, and Mylan have been moving to follow suit, according to FiercePharma.
Dr. Horovitz said, “Although we won’t know the results of these trials for some time, the advantage of trying out chloroquine and hydroxychloroquine as COVID-19 treatments is that the drugs’ safety profiles are well understood.”
These anti-malarial drugs are generally well tolerated at prescribed doses; however, they may cause GI upset, headache and rarely itchiness, according to the CDC. Please note that these drugs could lead to retinopathy, a rare eye condition, if overdosed.
Dr. Hahn explained that if these drugs are well-tolerated in human trials and found safe and effective at treating COVID-19, the FDA will immediately take measures to increase the supply of the drugs.
“If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it,” said Dr. Hahn.
“We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus.” The article was originally published on Live Science.
