FDA Revokes Authorization For Trump-Touted Meds To Treat Coronavirus

Henrietta Strickland
June 17, 2020

Following an evaluation of the emergency use authorization criteria and the scientific evidence available, the FDA issued an emergency use authorization (EUA) in May 2020 allowing for remdesivir to be distributed in the US and to be administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and pediatric patients hospitalized with severe disease. In April, former FDA leaders decried the agency's decision to authorize emergency use of the drugs, asserting it was based on political pressure, not scientific evidence.

Hydroxychloroquine received mass attention when U.S. president Donald Trump said he was taking the anti-malarial drug to prevent Covid-19.

'I have heard so many people who are so thrilled with the results from Hydroxy, ' Trump said. It will remain available for its previously approved conditions, which include rheumatoid arthritis and systemic lupus erythematosus as well as malaria, and can still be prescribed off-label at physicians' discretion.

It added that there is no data showing a reduction in mortality, length in hospital stay, or need for mechanical ventilation in COVID-19 patients treated with the drug.

Trump aggressively pushed hydroxychloroquine beginning in the first weeks of the outbreak and stunned medical professionals when he revealed he had taken the drug preemptively against infection.

The drugs have become a popular topic of discussion after being advocated for in combination with azithromycin by the president who even disclosed taking it himself. Chloroquine, which is not approved for any use in the United States, has also demonstrated mixed results in coronavirus studies.

"This is not a treatment for COVID-19". With CLEWICU healthcare providers use predictive screening information to help identify patients with an increased likelihood of being diagnosed with respiratory failure or hemodynamic instability which are common complications associated with COVID-19.

In response to the FDA's decision, President Trump also told reporters: "I took it and I felt good about taking it".

The FDA have also warned not to give HCQ to any COVID-19 parent receiving remdesivir, another drug touted as a potential treatment, and the only drug that has any authorisation for COVID-19 use.

Meanwhile, some 400 trials are listed as using hydroxychloroquine or chloroquine as interventions for COVID-19, more than half of them still ongoing, according to a recent analysis from research firm GlobalData. However, the medical journal later claimed that that the study had shortcomings leading the World Health Organization to restart the trial.

"You're not going to get sick and die".

Other reports by Click Lancashire

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