The Food and Drug Administration (FDA) withdrew its emergency use approval for the drugs hydroxychloroquine and chloroquine for the novel coronavirus treatment. Donald Trump, the President of the United States, previously touted hydroxychloroquine several times and claimed to use its daily dozes. According to the FDA website, it determines after studying the latest research on the drugs that these drugs do not meet the legal criteria for emergency use approval as they are not likely to be effective in treating coronavirus.
The FDA has determined that the drugs hydroxychloroquine and chloroquine do not meet “the statutory criteria” for emergency use authorization as they are unlikely to be effective in treating Covid-19 based on the latest scientific evidence https://t.co/RFNaXxwa6W
— CNN (@CNN) June 15, 2020
The agency concludes based on the latest information as well as other information discussed in the attached memo, it is no more reason to believe that oral formulas of CQ and HCQ may be effective to treat coronavirus, nor is it realistic to believe that the possible benefits of these drugs overshadow their possible risks, according to the FDA chief scientist Denise Hinton’s letter to Gary Disbrow of the Biomedical Advanced Research & Development Authority (BARDA).
Chloroquine and hydroxychloroquine tied to serious cardiac threats along with other side effects among coronavirus patients. Hinton wrote in a letter using abbreviations for chloroquine and hydroxychloroquine. Consequently, the Food and Drug Administration revokes emergency use authorization (EUA) for emergency use of CQ and HCQ to treat coronavirus.
Doctors can continue to prescribe the drugs off-label legally
Doctors can still continue to advise the drugs off-label to patients, as they can with any drug appropriate for their conditions. The emergency use of authorization of the FDA for chloroquine and hydroxychloroquine was narrow in scope. It applied only to hospitalized coronavirus patients and only to drugs donated to the Strategic National Stockpile (SNS). On Monday, the FDA also warned against giving hydroxychloroquine and chloroquine to coronavirus patients who are also taking remdesivir, one of the drugs that have any authorization for use in treating COVID-19.
The FDA warned that mixing remdesivir (an infused antiviral drug) and either controversial drugs might reduce the remdesivir’s effectiveness. FDA is not aware of examples of this small level activity occurring in the clinical setting but is continuing to assess all information about remdesivir. Dr. Stephen Hahn, the FDA commissioner, seemed to defend the decision of the agency to issue the approval in an open letter published last month. The conclusion based on the assessment of the EUA criteria as well as the scientific evidence present at that time.
The World Health Organization (WHO) states that it continues to review the use of hydroxychloroquine in its Solidarity Trial (a multi-country clinical study of coronavirus treatment). For the time being, WHO paused the trial in May because of the concerns surrounding the safety of the drug and to review its own statistics, however, it restarted the program earlier this month.