FDA revokes emergency authorization for chloroquine and hydroxychloroquine in COVID-19 treatment

A chemist displays hydroxychloroquine tablets in Kolkata,India on April 10,2020. Amidst concerns over domestic shortage, India has lifted the ban on some drug exports including hydroxychloroquine. (Photo by Debajyoti Chakraborty/NurPhoto via Getty Images)
A chemist displays hydroxychloroquine tablets in Kolkata,India on April 10,2020. Amidst concerns over domestic shortage, India has lifted the ban on some drug exports including hydroxychloroquine. (Photo by Debajyoti Chakraborty/NurPhoto via Getty Images)
Darrell Etherington

The U.S. Food and Drug Administration (FDA) has revoked an emergency use authorization (EUA) that it previously issued for chloroquine and hydroxychloroquine, two anti-malarial drugs also used in the treatment of chronic rheumatoid arthritis (via The Washington Post). These are the drugs that President Trump famously touted as effective in COVID-19 treatment, despite major concerns raised with the scientific validity of early medical investigations that showed they were potentially effective against the infection beyond the ongoing global pandemic.

Subsequent studies showed conflicting results, including when one team of researchers ended elements of its clinical study into the drugs' use early due to excess fatalities. The FDA had issued its EUA for use of chloroquine and hydroxychloroquine in late March, prompting criticism from many in the medical and pharmaceutical research community since evidence seemed very mixed in terms of its potential efficacy and risks. Then following those deaths in that subsequent clinical study, it issued a statement of precaution regarding the use of the drugs.

The FDA grants EUAs in circumstances where it deems the benefits outweigh the risks of expediting a provisional authorization for the use of therapies and devices that haven't undergone its full, rigorous approval process for drugs and equipment. The COVID-19 pandemic has resulted in the FDA releasing many more EUAs than is typical, especially as it pertains to testing equipment used for diagnostics of the infection and SARS-CoV-19, its preceding and causal virus.

Trump irresponsibly touted the value of chloroquine and hydroxychloroquine, and later professed to be taking the medicine himself as a precaution he wrongly believed would stave off infection. The drug's supply subsequently experienced a number of stresses due to increased demand, which had potentially dire consequences for people with a legitimate need for its consumption due to conditions for which it is approved and clinically shown to be effective, including lupus and chronic arthritis.

More From

  • Facebook makes education push in India

    Facebook, which reaches more users than any other international firm in India, has identified a new area of opportunity to further spread its tentacles in the world’s second largest internet market. On Sunday, the social juggernaut announced it had partnered with the Central Board of Secondary Education, a government body that oversees education in private and public schools in India, to launch a certified curriculum on digital safety and online well-being, and augmented reality for students and educators. Through these subjects, Facebook and CBSE aim to prepare secondary school students for current and emerging jobs, and help them develop skills to safely browse the internet, make “well informed choices,” and think about their mental health, they said.

  • Rocket Lab launch fails during rocket's second stage burn, causing a loss of vehicle and payloads

    Rocket Lab's 'Pic or it didn't happen' launch on Saturday ended in failure, with a total loss of the Electron launch vehicle and all seven payloads on board. The launch vehicle experienced a failure during the second stage burn post-launch, after a lift-off from the Rocket Lab Launch Complex 1 on Mahia Peninsula in New Zealand. The mission appeared to be progressing as intended, but the launch vehicle appeared to experience unexpected stress during the 'Max Q' phase of launch, or the period during which the Electron rocket experiences the most significant atmospheric pressure prior to entering space.

  • How to watch Rocket Lab launch satellites for Canon, Planet and more live

    Rocket Lab is launching a rideshare mission today which includes seven small satellites from a number of different companies, including primary payload provider Canon, which is flying a satellite equipped with the camera-maker's Earth imaging technology, including high-res photo capture equipment. The Electron rocket that Rocket Lab is flying today will also carry five Planet SuperDove Earth-Observation satellites, as well as a CubeSat from In-Space missions. The launch, which is named 'Pics or It Didn't Happen' is set to take place during a window which opens at 5:19 PM EDT (2:19 PM PDT) and extends until 6:03 PM EDT (3:03 PM EDT), lifting off from Rocket Lab's Launch Complex 1 on the Mahia Peninsula in New Zealand.

  • How Have I Been Pwned became the keeper of the internet's biggest data breaches

    When Troy Hunt launched Have I Been Pwned in late 2013, he wanted it to answer a simple question: Have you fallen victim to a data breach? Seven years later, the data-breach notification service processes thousands of requests each day from users who check to see if their data was compromised — or pwned with a hard 'p' — by the hundreds of data breaches in its database, including some of the largest breaches in history. As it's grown, now sitting just below the 10 billion breached-records mark, the answer to Hunt's original question is more clear.