FDA Revokes Emergency Hydroxychloroquine Approval Over Side Effects Concerns


The Food and Drug Administration on Monday revoked its permission for physicians to use the antimalarial drugs chloroquine and hydroxychloroquine on patients hospitalized with the COVID-19 coronavirus.

FDA officials said the medications, which were promoted by President Donald Trump as a possible "game-changer" in the fight against the illness, are "unlikely to be effective," and since they carry the possibility of serious side effects, including cardiac arrhythmia, their potential benefits "no longer outweigh the known and potential risks."

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The announcement comes as the use of hydroxychloroquine for COVID-19 has declined at Veterans Affairs medical facilities. VA prescribed the drug to treat at least 1,300 patients with the illness. Use at VA peaked the week of March 29, with 404 patients receiving it.

In the last week of May, however, VA physicians used it just three times, according to VA Secretary Robert Wilkie.

Research surrounding chloroquine and hydroxychloroquine’s effectiveness as a COVID-19 treatment has been mired in controversy since French researchers published a small study that showed it lowered virus counts in 20 patients within a week of it being administered, and cured six patients when paired with the antibiotic azithromycin.

But the scientific rigor of that study, along with additional research by the same scientists, has been questioned.

A retrospective review of the use of hydroxychloroquine on VA patients with COVID-19 found that 28% of veterans who received the drug died; and 22% of those who received hydroxychloroquine, along with the antibiotic azithromycin, also died; while just 11% of patients in the study who received standard care died.

Still, that research didn't provide much insight on its effectiveness, either, since it was a simple analysis of the data on its use among those who were severely ill, on ventilators and suffering from underlying health conditions. All participants in that research were men, nearly all were black and all had a median age over 65 -- demographics that placed them at higher risk for severe cases of the coronavirus.

Other research that questioned the safety of chloroquine and hydroxychloroquine was retracted after the data the studies were based on was found to be faulty.

FDA officials said they made their decision on a large randomized clinical trial in hospitalized patients that showed hydroxychloroquine had no benefit on mortality or in speeding recovery. They also reviewed data that "suggested dosing regimens ... were unlikely to kill or inhibit" the SARS-CoV-2 coronavirus.

Dr. Remington Nevin, a former Army physician who now runs a nonprofit organization dedicated to helping people sickened by certain antimalarial drugs, was among the first to sound the alarm on the chloroquine’s potentially dangerous side effects.

He said his organization, The Quinism Foundation, plans to send a letter to the Department of Health and Human Services requesting that patients who suffered side effects from taking the medications for COVID-19, including some neurological and psychiatric conditions, receive compensation for their injuries.

"Attention should now be focused on ensuring HHS works with FDA and other organizations to ensure they provide appropriate compensation for injuries sustained by those who were harmed by the drugs' use under the emergency use authorization, through the existing mechanisms of the pandemic Countermeasures Injury Compensation Program," Nevin said.

The number of VA patients with active cases of the COVID-19 coronavirus has risen steadily in June, from 1,494 on June 2 to 1,767 as of June 15. A total of 17,132 veterans in the VA health system have contracted the virus since the outbreak began and 1,438 have died.

Thirty-four VA employees also have died.

During congressional testimony May 28, Wilkie said VA doctors opted to give patients the choice to take the medication because "there has to be hope."

"That may be the last thing that separates them from life and death," Wilkie said.

-- Patricia Kime can be reached at Patricia.Kime@Monster.com. Follow her on Twitter @patriciakime.

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