FDA revokes emergency use authorization for chloroquine, hydroxychloroquine

Henrietta Strickland
June 16, 2020

The Food and Drug Administration said Monday that chloroquine and hydroxychloroquine "are unlikely to be effective in treating Covid-19". Citing reports of heart complications, the FDA said the drugs pose a greater risk to patients than any potential benefits.

The FDA had authorized the drugs for use in hospitalized patients with Covid-19 in March after Trump said they could be effective against the virus despite a lack of clinical evidence. The end of the drug's emergency use for coronavirus treatment will not change its use for other treatments. The Indian drug makers supply over 70 percent of the global demand for HCQ, and had increased their capacities several times to meet the demand for Covid-19 treatment globally.

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. While the drugs are deemed generally safe when prescribed for patients with malaria or an autoimmune disease, little was otherwise known about the potential effects they had in COVID-19 patients. "I hope this is a step forward to FDA regaining its independence and for making decisions that are based on science and the public interest", says Luciana Borio, a former FDA acting chief scientist who directed medical and biodefense preparedness for Trump's National Security Council.

On May 25, the World Health Organization (WHO) announced it was suspending testing of hydroxychloroquine due to its own safety concerns.

His comments about hydroxychloroquine became the subject of widespread speculation online and controversy within the scientific community about the potential benefits and harmful effects of the drug - along with the related drug, chloroquine.

Trump irresponsibly touted the value of chloroquine and hydroxychloroquine, and later professed to be taking the medicine himself as a precaution he wrongly believed would stave off infection.

Whitsett said she heard about the drugs during a press conference held by Trump.

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

"In fact the FDA removal of the emergency use authorisation takes away what had been a significant misunderstanding by many that had made people think it could only be used in a hospital setting", Azar added. Other current and former Health and Human Services officials later said that the emergency authorities and White House demands cast a shadow on FDA as it struggled to remain independent.

Other reports by Click Lancashire

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