Citing Heart Problems, FDA Calls For Limiting Use Of Antimalarial Drugs Trump Championed

A Salvadoran Health Ministry worker shows a package of bottles of HydroxyChloroquine pills to be distributed in hospitals in San Salvador on April 21, 2020, amid the COVID-19 coronavirus outbreak. (Photo by Yuri CORT... A Salvadoran Health Ministry worker shows a package of bottles of HydroxyChloroquine pills to be distributed in hospitals in San Salvador on April 21, 2020, amid the COVID-19 coronavirus outbreak. (Photo by Yuri CORTEZ / AFP) (Photo by YURI CORTEZ/AFP via Getty Images) MORE LESS
|
April 24, 2020 12:22 p.m.

The Food and Drug Administration on Friday warned that heart complications caused by the antimalarial medications championed by President Donald Trump “can be life-threatening.”

The FDA flagged “reports of serious heart rhythm problems” in COVID-19 patients treated with the antimalarials Trump has hyped, hydroxychloroquine or chloroquine. It also pointed out the “increased use of these medicines through outpatient prescriptions.”

“Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine,” the agency said, warning against using the drugs outside of a clinical or hospital setting.

Trump has for weeks boosted the drugs despite the lack of widespread evidence that they are effective against COVID-19.

Newsletters
Get TPM in your inbox, twice weekly.
Your subscription could not be saved. Please try again.
Your subscription has been successful.

A study of VA hospital patients recently failed to find hydroxychloroquine effective against the disease, and a Brazilian study of chloroquine use on COVID-19 patients was halted due to the risk of fatal heart rate irregularities like those described in the FDA warning.

Just last month the FDA issued an emergency use authorization, or EUA, to allow millions of donated doses of chloroquine and hydroxychloroquine to be distributed to hospitals through state public health officials. The director of the agency that received the authorization, who was recently demoted to another role, alleged this week that he faced political pressure to allow the widespread use of the drug.

At the time the EUA was issued, in late March, medical and regulatory experts rang alarm bells about insufficient evidence supporting the drugs.

“I would like to see who [at the FDA’s Medical Countermeasures Initiative] signed off on this EUA despite the total lack of scientific evidence that chloroquine/hydroxychloroquine are beneficial in the treatment of COVID-19,” Luciana Borio, the FDA’s former acting top scientist, wrote in response to the emergency authorization.

“EUA is supposed to be issued when the evidence indicates that benefits outweigh the risks.”

Trump’s boosterism of the drugs has prompted fear among regular users — the medicines were used to treat lupus and rheumatoid arthritis long before the COVID-19 pandemic — about supply issues. The heart complications among COVID-19 patients using the antimalarials have arisen more recently as the drugs have come under increased scrutiny.

“We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available,” the FDA wrote.

Latest News
Comments are now Members-Only

Non-members are still able to read comments, but will no longer be able to participate. To join the conversation, sign up now and get:

30% Off Annual Prime Membership

TPM strives to build as inclusive a community as financially possible. We offer FREE memberships to those experiencing financial hardship and FREE memberships for students.

View all options
Comments
Masthead Masthead
Founder & Editor-in-Chief:
Executive Editor:
Managing Editor:
Associate Editor:
Investigations Desk:
Reporters:
Newswriters:
Audience Development Editor:
Editor at Large:
General Counsel:
Publisher:
Head of Product:
Director of Technology:
Associate Publisher:
Front End Developer:
Senior Designer: