AP

US revokes emergency use of virus drugs touted by Pres. Trump

Jun 15, 2020, 4:03 PM

FILE - In this April 9, 2020 file photo, a chemist displays hydroxychloroquine tablets in New Delhi...

FILE - In this April 9, 2020 file photo, a chemist displays hydroxychloroquine tablets in New Delhi, India. U.S. regulators are revoking emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19. The Food and Drug Administration said Monday, June 15 that the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. (AP Photo/Manish Swarup, File)

(AP Photo/Manish Swarup, File)

WASHINGTON (AP) — U.S. regulators on Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause serious side effects.

The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”

In a separate announcement, the FDA also warned doctors against prescribing the drugs in combination with remdesivir, the lone drug currently shown to help patients with COVID-19. The FDA said the anti-malaria drugs can reduce the effectiveness of remdesivir, which FDA cleared for emergency use in May.

Hydroxychloroquine and chloroquine are frequently prescribed for lupus and rheumatoid arthritis and can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.

The agency reported Monday that it had received nearly 390 reports of complications with the drugs, including more than 100 involving serious heart problems. Such reports represent an incomplete snapshot of complications with the drugs because many side effects go unreported.

FDA’s move means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities for use against the coronavirus. The decades-old drugs are still available for alternate FDA-approved uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.

Dr. Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser, agreed with the decision and said he would not have granted emergency access in the first place.

“There has never been any high-quality evidence suggesting that hyrdoxychloroquine is effective” for treating or preventing coronavirus infection, he said, but there is evidence of serious side effects.

On Thursday, a National Institutes of Health panel of experts revised its recommendations to specifically recommend against the drug’s use except in formal studies, and “that, I’m sure, had influence on the FDA,” Nissen said.

The actions by FDA and NIH send a clear signal to health professionals against prescribing the drugs for coronavirus.

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. After Trump’s repeated promotions, prescriptions for hydroxychloroquine soared, contributing to shortages.

No large, rigorous studies have found the drugs safe or effective for preventing or treating COVID-19. And a string of recent studies made clear they could do more harm than good.

Dr. Peter Lurie, a former FDA associate commissioner and an Obama administration appointee, said the agency had tarnished its reputation by clearing the drugs based on scant evidence and under apparent political pressure.

“This is an agency that gains its credibility from the strength of its scientific pronouncements,” said Lurie, now president of the nonprofit Center for Science in the Public Interest. “The lesson of this whole tawdry episode is that it’s the old, painstaking ways of science that ultimately deliver safe and effective therapies.”

The only remaining drug with FDA authorization against COVID-19 is remdesivir, an intravenous medication from Gilead Sciences that has been shown to help severely ill, hospitalized patients recover faster.

Late Monday afternoon, the FDA announced it would update remdesivir’s prescribing label to warn against combining it with hydroxychloroquine or chloroquine. The agency said results from laboratory tests suggest the drugs interfere with remdesivir’s virus-fighting ability in human cells. Despite that risk, regulators said they have not yet seen the problem in patients.

The FDA granted emergency use for the anti-malaria drugs in late March at the same time the U.S. government accepted 30 million doses of hydroxychloroquine and chloroquine that had been donated by two foreign drug manufacturers. Millions of those doses were shipped to U.S. hospitals to treat patients who weren’t enrolled in clinical trials.

But the FDA previously warned doctors that it had seen reports of dangerous side effects and heart problems reported to poison control centers and other health systems.

The agency said it revoked the authorization in consultation with the Biomedical Advanced Research and Development Authority, or BARDA, which had requested the emergency use.

BARDA’s former director said in April that he was removed from his job because he resisted political pressure from Trump appointees to allow widespread use of the malaria drugs. Rick Bright said he worked with FDA senior staff to limit the drugs’ authorization to patients hospitalized with COVID-19 and under professional supervision.

Among other issues, Bright objected to the fact that some of the doses imported were manufactured at facilities in India and Pakistan that had not been inspected by the FDA. Bright is seeking reinstatement to his position at BARDA after being transferred to the NIH.

The FDA says it sampled and tested the imported drugs to confirm they met the agency’s standards for safety and quality.
___
Follow Matthew Perrone on Twitter: @AP_FDAwriter
___
AP Chief Medical Writer Marilynn Marchione contributed to this report from Milwaukee.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

AP

Republican presidential candidate former UN Ambassador Nikki Haley speaks at a Republican campaign ...

WILL WEISSERT Associated Press

Haley says she raised $12M in February, can’t point to long-term plan to beat Trump

Republican presidential candidate Nikki Haley said Friday that she raised $12 million in February, a haul that will likely allow her to remain in the Republican primary against former President Donald Trump past next week's Super Tuesday — even though she can't point to an upcoming state where she expects to beat him.

3 days ago

February, 29, otherwise know as leap year day, is shown on a calendar Sunday, Feb. 25, 2024, in Ove...

LEANNE ITALIE AP Lifestyles Writer

What would happen without a Leap Day? More than you might think

Leap year. It's a delight for the calendar and math nerds among us. So how did it all begin and why?

4 days ago

Republican presidential candidate former President Donald Trump speaks at a primary election night ...

MEG KINNARD and WILL WEISSERT Associated Press

Trump wins South Carolina, easily beating Haley in her home state and closing in on GOP nomination

Donald Trump won South Carolina's Republican primary on Saturday further consolidating his path to a third straight GOP nomination.

9 days ago

Hannah Gutierrez-Reed, center, sits with her attorney Jason Bowles, left, during the first day of t...

MORGAN LEE Associate Press

Negligence or scapegoating? Trial of ‘Rust’ armorer begins in fatal shooting by Alec Baldwin

Prosecutors sought to pin blame on a movie weapons supervisor for bringing live ammunition on set that contributed to the fatal shooting of a cinematographer by Alec Baldwin during production of the film "Rust."

11 days ago

A pail rests next to caution tape on a beach in Lauderdale-by-the-Sea, Fla., on Tuesday, Feb. 20, 2...

Associated Press

Young girl killed when a hole she dug in the sand collapsed on a Florida beach, authorities said

A young girl died Tuesday when a deep hole she was digging collapsed on her at a south Florida beach, authorities said.

12 days ago

A Gila monster is displayed at the Woodland Park Zoo in Seattle, Dec. 14, 2018....

MEAD GRUVER Associated Press

A Colorado man is dead after a pet Gila monster bite

A Colorado man has died after being bitten by his pet Gila monster in what would be a rare death if the creature's venom was the cause.

13 days ago

Sponsored Articles

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

front of the Butch Cassidy museum with a man in a cowboy hat standing in the doorway...

Bear Lake Convention and Visitors Bureau

Looking Back: The History of Bear Lake

The history of Bear Lake is full of fascinating stories. At over 250,000 years old, the lake has seen generations of people visit its shores.

silhouette of a family looking over a lake with a bird in the top corner flying...

Bear Lake Convention and Visitors Bureau

8 Fun Activities To Do in Bear Lake Without Getting in the Water

Bear Lake offers plenty of activities for the whole family to enjoy without having to get in the water. Catch 8 of our favorite activities.

Wellsville Mountains in the spring with a pond in the foreground...

Wasatch Property Management

Advantages of Renting Over Owning a Home

Renting allows you to enjoy luxury amenities and low maintenance without the long-term commitment and responsibilities of owning a home.

Clouds over a red rock vista in Hurricane, Utah...

Wasatch Property Management

Why Southern Utah is a Retirement Paradise

Retirement in southern Utah offers plenty of cultural and recreational opportunities. Find out all that this region has to offer.

US revokes emergency use of virus drugs touted by Pres. Trump