Loading...

FDA Revokes Emergency Use of Hydroxychloroquine to Fight Coronavirus

June 15, 2020 by Dan McCue
FDA Revokes Emergency Use of Hydroxychloroquine to Fight Coronavirus
A chemist displays hydroxychloroquine tablets. 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)

WASHINGTON – The Food and Drug Administration revoked its emergency authorization of hydroxychloroquine and chloroquine for treating COVID-19 as evidence mounts that the drugs don’t work and can cause serious side effects.

“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” said Dr. Anand Shah, FDA deputy commissioner for Medical and Scientific Affairs.

Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation, said while additional clinical trials will continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, “we determined the emergency use authorization was no longer appropriate.”

Cavazzoni explained the decision to revoke the drugs emergency approval was taken following “a rigorous assessment” by scientists at the Center for Drug Evaluation and Research.

“We remain committed to using every tool at our disposal in collaboration with innovators and researchers to provide sick patients timely access to appropriate new therapies,” Cavazzoni said. “Our decisions will always be based on objective and rigorous evaluation of the scientific data. This will never change.”

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

All this despite the fact no large studies have found the drugs safe or effective for preventing or treating COVID-19.

Last week, a National Institutes of Health panel of experts revised its recommendations to specifically recommend against the drug’s use except in formal studies

The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.

The FDA’s formal statement on the matter said, “in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The agency’s decision 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. 

In The News

Health

Voting

Health

January 14, 2022
by Dan McCue
White House Announces Plans to Distribute Home COVID Tests

WASHINGTON — Beginning Jan. 19, Americans will be able to order free at-home COVID-19 tests online from the federal government,... Read More

WASHINGTON — Beginning Jan. 19, Americans will be able to order free at-home COVID-19 tests online from the federal government, a senior White House official announced Friday afternoon. In the early going of the new program, individuals will be limited to four free tests per residential... Read More

Mask Rules Get Tighter in Europe in Winter's COVID-19 Wave

ROME (AP) — To mask or not to mask is a question Italy settled early in the COVID-19 outbreak with... Read More

ROME (AP) — To mask or not to mask is a question Italy settled early in the COVID-19 outbreak with a vigorous “yes." Now the onetime epicenter of the pandemic in Europe hopes even stricter mask rules will help it beat the latest infection surge. Other... Read More

January 12, 2022
by Reece Nations
House Rules Committee Rejects G.I. Bill Education Benefits for Vaccine Refusal

WASHINGTON — The House Rules Committee on Monday rejected an amendment to the Guard and Reserve G.I. Bill Parity Act... Read More

WASHINGTON — The House Rules Committee on Monday rejected an amendment to the Guard and Reserve G.I. Bill Parity Act that would guarantee Armed Services members discharged for refusing the COVID-19 vaccine are eligible for G.I. Bill education benefits. The Guard and Reserve G.I. Bill Parity... Read More

January 12, 2022
by Alexa Hornbeck
Reliability of Antigen Rapid Tests in Detecting Early Omicron Questioned

WASHINGTON — Beginning Jan. 15, private health insurers will be required to cover the cost of home testing kits despite... Read More

WASHINGTON — Beginning Jan. 15, private health insurers will be required to cover the cost of home testing kits despite recent concerns from elected officials and researchers over the reliability and availability of rapid antigen testing. “I’ve heard from so many people who are waiting in... Read More

January 12, 2022
by Alexa Hornbeck
COVID Pills Show Promise for Combating Severe Infection

Pfizer’s Paxlovid is the first pill treatment to combat severe COVID-19 infection, and new figures from Israel’s Ministry of Health... Read More

Pfizer’s Paxlovid is the first pill treatment to combat severe COVID-19 infection, and new figures from Israel’s Ministry of Health show the pill may hold promise in saving lives. Shortly before Christmas Day, Paxlovid was authorized for at-home treatment of high-risk COVID-19 infections in patients over... Read More

January 12, 2022
by Alexa Hornbeck
Researchers Develop mRNA-based Lyme Disease Vaccine

Yale researchers recently developed an mRNA-based Lyme disease vaccine capable of targeting antigens in tick saliva to prevent their ability... Read More

Yale researchers recently developed an mRNA-based Lyme disease vaccine capable of targeting antigens in tick saliva to prevent their ability to transmit pathogens.  According to the CDC, nearly half a million people in the U.S. are diagnosed with Lyme Disease every year. The ailment is most... Read More

News From The Well
Exit mobile version