On Monday, the US Food and Drug Administration (FDA) stripped hydroxychloroquine, the malaria drug touted by Trump, of its emergency use authorization for treating coronavirus patients.
It comes after Dr Gary Brisbow, director of the Biomedical Advanced Research and Development Authority’s medical countermeasure programs requested the FDA revoke the controversial drug’s status.
Already, the FDA had issued a warning about the use of the drug outside clinical trials or hospitals, due to its potential to cause dangerous heart side effects, and the National Institutes of Health (NIH) recommended its use be isolated to trials.
Earlier this month, a study linking the drug to a higher risk of death in COVID-19 patients was retracted from the medical journal The Lancet, reigniting debates over the drug and its safety.
But the FDA cites new data from a clinical trial as evidence that the drug does not help coronavirus patients recover, and may pose risks that outweigh its potential benefits.
Because hydroxychloroquine has long been approved for treating other conditions – malaria, lupus and rheumatoid arthritis – it could still be used ‘off-label’ and clinical trials may continue.