FDA warning on 'Off-Label' use of antimalarial drugs to treat COVID-19

The US Food and Drug Administration on Friday issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA.

These risks, which are in the drug labels for their approved uses, currently for malaria and certain inflammatory conditions such as Lupus and rheumatoid arthritis, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19.

The potential benefits of hydroxychloroquine and chloroquine in the treatment of the novel coronavirus, following US President Donald Trump lauding it as a ‘game changer,’ has attracted donations of the decades-old generic drug from a number of drug majors, and just last week the FDA greed that Swiss pharma giant (NOVN: VX) can proceed with a Phase III clinical trial in the USA with around 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease.