Skip to main content

New story in Health from Time: The FDA Revoked Emergency Use Authorization for Hydroxychloroquine, Citing New Evidence



The U.S. Food and Drug Administration (FDA) announced today that it is revoking the emergency use authorization for hydroxychloroquine and chloroquine, citing a lack of evidence that these drugs are effective for COVID-19.

Early on in the pandemic, doctors scrambling to find a way to treat the disease widely prescribed hydroxychloroquine to their sickest patients, based on thin evidence from a handful of relatively weak studies. However, recent research has made it increasingly clear that the drug is likely ineffective against the disease, and that it carries a risk of significant side effects, including heart problems.

The chief scientist for the FDA, Denise M. Hinton, announced the decision in a letter to the Biomedical Advanced Research and Development Authority (BARDA) on Monday. “Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19,” she wrote, adding that it is “no longer reasonable” to believe that the drug combination’s benefits outweigh the potential side effects.

Hydroxychloroquine is a slightly different version of chloroquine, a drug discovered to fight malaria decades ago. Scientists developed hydroxychloroquine as a replacement for malaria treatment, with fewer side effects; today, in the U.S. it’s mainly prescribed to treat the inflammation related to autoimmune disorders like rheumatoid arthritis and lupus.

As the U.S. pandemic surged in March, President Donald Trump championed hydroxychloroquine as a potential COVID-19 treatment, calling it a possible “game-changer.” Trump encouraged others to take the drug, and later claimed to have undergone a two-week regimen of hydroxychloroquine himself in an effort to ward off the disease. Medical experts widely criticized President Trump for promoting a potentially dangerous drug before its benefits were proven, and warned of the possible risks of the public self-medicating.

The FDA said in a statement on Monday that the FDA regularly reviews drugs under an emergency use authorization, and has reviewed new information, including a large clinical trial of hospitalized patients that showed that the drug didn’t appear to help people get better faster, or reduce the risk of mortality.

“While additional clinical trials 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. This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Dr. Patrizia Cavazzoni, the acting director of the FDA’s Center for Drug Evaluation, said in the statement.

Labels:

Popular posts from this blog

New story in Health from Time: COVID-19 Has Been ‘Apocalyptic’ for Public Transit. Will Congress Offer More Help?

While trying to get to work over the past few months, Brittany Williams, a Seattle home care worker, has often been passed by two or three buses before one stops to let her board. Buses in her area that once carried anywhere from about 50 to 100 passengers have been limited to between 12 and 18 to prevent overcrowding in response to coronavirus, and Williams’ commute, typically a half-hour ride, now takes more than double that time. Other Seattle transit riders have described budgeting as much as an extra hour per trip to account for the reduced capacity, eating into their time at work, school or with family. Even with the ridership limits in place, Williams, 34, doesn’t feel safe on public transit. Some passengers don’t wear face coverings, and bus drivers sometimes ignore capacity limits, she says. On one ride with her seven-year-old son, she decided to get off at a stop far from her home after a driver allowed a crowd of people to board. “It’s very trying. I’ll put...
Read more

New video by blogilates on YouTube

Day 8 - 14 | Blogilates 2020 Challenge You guys are CRUSHING the #2020Challenge so far! Idk about you but my abs are soooooore! This week, we're doing 20 reps of abs every day + 20 reps of another new exercise every day! If you need a little extra motivation, text my number (510-692-4556) and tell me all about it so we can come up with a solution together! This link also works: https://ift.tt/2Qjqw7G This week's moves are: Jan. 8th (starts 0:48) - 20 butterfly bridges + 20 criss cross (butt + abs) Jan. 9th (starts 2:43) - 20 oil riggers + 20 rollovers (arms + abs) Jan. 10th (starts 8:29) - 20 lunges + 20 leg outs (legs + abs) Jan. 11th (starts 11:03) - 20 walnut crushers + 20 single leg drops (back + abs) Jan. 12th (starts 13:41) - 20 sprinters + 20 crunches (obliques + abs) Jan. 13th (starts 16:27) - 20 squat jumps + 20 russian twists (cardio + abs) Jan. 14th (starts 18:57) - 20 plank jacks + 20 butt ups (total body + abs) Here is where I get all of my music! Epidemic Sound: ...
Read more

New story in Health from Time: Coronavirus Cases Outside China Are Accelerating Rapidly. Here’s What to Know

A surge in deadly coronavirus cases outside China is raising concerns that the outbreak has reached a new stage and could continue its global spread to even more vulnerable countries. In the central Chinese province of Hubei, where the virus is believed to have originated, the number of cases appears to be stabilizing, according to government figures. But the number of people infected elsewhere in the world is rising quickly, with clusters in South Korea , Italy, Iran and a cruise ship docked in Japan. As of Monday, more than 2,200 cases of the virus, officially called COVID-19, have been reported outside of mainland China, where the overwhelming majority of the 79,000 cases have been located since officials first discovered the disease in December. The number of deaths outside China has also increased to 166, including 50 in Iran and four in Italy. In a news conference Monday, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said the WHO...
Read more