facebook linkedin twitter

FDA Revokes Emergency Use of Hydroxychloroquine to Fight Coronavirus

June 15, 2020 by Dan McCue
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

August 5, 2021
by Alexa Hornbeck
The New Social Determinants Caucus

Two weeks ago, Reps. Cheri Bustos, D-Ill.,Tom Cole, R-Okla., G.K. Butterfield, D-N.C., and Markwayne Mullin, R-Okla., created a new Social... Read More

Two weeks ago, Reps. Cheri Bustos, D-Ill.,Tom Cole, R-Okla., G.K. Butterfield, D-N.C., and Markwayne Mullin, R-Okla., created a new Social Determinants Caucus, which will coordinate federal investments in health and social drivers of health such as food, housing and transportation. “The reason you start a caucus... Read More

August 5, 2021
by Alexa Hornbeck
New Rules Could Take Californiaʼs Pork Supply Offline

The California Farm Confinement Proposition, known as Prop 12, is set to become effective next year and could mean that... Read More

The California Farm Confinement Proposition, known as Prop 12, is set to become effective next year and could mean that pork suppliers lose access to California’s large market. The law will implement space requirements for chickens, calves, and hogs, such as retrofitting buildings, and will also... Read More

Head of UN Health Agency Seeks Vaccine Booster Moratorium

GENEVA (AP) — The head of the World Health Organization called Wednesday for a moratorium on administering booster shots of... Read More

GENEVA (AP) — The head of the World Health Organization called Wednesday for a moratorium on administering booster shots of COVID-19 vaccines as a way to help ensure that doses are available in countries where few people have received their first shots.  WHO Director-General Tedros Adhanom... Read More

August 4, 2021
by Alexa Hornbeck
Genome Sequencing of Newborns Can Save Lives and Lower Medical Costs

Over the last decade evidence has shown that whole genome sequencing saves lives, but a new study from researchers in... Read More

Over the last decade evidence has shown that whole genome sequencing saves lives, but a new study from researchers in California shows how genome sequencing for newborns in intensive care units can also save money. “We now know there are more than 6,000 genetic diseases, but... Read More

August 4, 2021
by Alexa Hornbeck
COVID-19 Pandemic Increases Demand for Cosmetic Procedures

As COVID-19 lockdown orders have lifted and many individuals are returning to social activities, cosmetic surgeons across the country are... Read More

As COVID-19 lockdown orders have lifted and many individuals are returning to social activities, cosmetic surgeons across the country are seeing an increase in the demand for cosmetic procedures. “I’ve never seen a jump this high, most practices do get busier and it’s pretty predictable, but... Read More

Fauci: More 'Pain and Suffering' Ahead as COVID Cases Rise

Dr. Anthony Fauci warned Sunday that more "pain and suffering" is on the horizon as COVID-19 cases climb again and... Read More

Dr. Anthony Fauci warned Sunday that more "pain and suffering" is on the horizon as COVID-19 cases climb again and officials plead with unvaccinated Americans to get their shots. Fauci, the nation's top infectious disease expert, also said he doesn't foresee additional lockdowns in the U.S.... Read More

News From The Well
scroll top