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

Labels:

Popular posts from this blog

New story in Health from Time: Here’s How Quickly Coronavirus Is Spreading in Your State

The novel coronavirus pandemic is a global crisis, a national emergency and a local nightmare. But while a great deal of the focus in the U.S. has been on the federal government’s response, widely criticized as slow and halting , the picture on the ground remains very different in different parts of the country. A TIME analysis of the per capita spread of the epidemic in all 50 states and Washington, D.C. found considerable range in the rate of contagion, and, in some parts of the country, a significant disparity compared to the national figure. The U.S., unlike nations such as South Korea and now Italy , has yet to show signs of bringing the runaway spread of the virus under control. However, while no single state is yet showing strong signs of bending the curve , some are faring much worse than others. The following graphic plots the rise in the total confirmed cases of COVID-19 per 100,000 residents in each state, plotted by the day that each state reported its first case....
Read more

New video by gymvirtual on YouTube

Rutina para adelgazar | Ejercicios para perder peso en casa ♥ ♥ LÉEME / DESPLIÉGAME ♥ ♥ Hola a todos, hoy os traigo una rutina de cardio de 25 minutos para quemar grasa y adelgazar en casa. En la web https://ift.tt/39VJREp encontraréis los calendarios de entrenamiento tanto para principiantes como para avanzados. Si quieres conseguir tú transformación en solamente 12 semanas, entra ya en http://www.pgv12.com y elige el PLAN PGV12 que más se adapte a ti. Nuestro lema: YO PUEDO CON TODO Los hashtags: #GymVirtual #YPCT #YoPuedoConTodo #PGV12 ♡♡ ¡SUSCRÍBETE! ♡♡ http://www.youtube.com/user/gymvirtual ................................................................................................................................. ♡♡ PLAN DE ENTRENAMIENTO + NUTRICIÓN 12 SEMANAS♡♡ http://www.pgv12.com ................................................................................................................................. ♡♡¡ECHA UN VISTAZO A NUESTRA TIENDA ONLINE! ♡♡ https://ift.tt/2Un...
Read more

New story in Health from Time: After Cruise Ships and Nursing Homes, Will Universities Be the Next COVID-19 Tinderboxes?

The fall semester has yet to begin, but student athletes training for the season can already be found on college campuses across the U.S. And so can COVID-19. Since the start of July there have been at least two outbreaks among student athletes, coaches, and staff—with 37 infected at the University of North Carolina (UNC) Chapel Hill and 22 at Boise State . Clusters of infection have been traced to college town bars popular with students. A common misconception is that young people with COVID-19 don’t die and therefore college re-openings pose little risk. Sadly, this isn’t the case. COVID-19 deaths in the young are rare, but they happen. Universities across the U.S. are mourning the loss of students in the lead-up to the school year, including Joshua Bush , a 30-year old nursing student at the University of South Carolina, Trevor Syphus Lee , a 27-year old senior at Utah Valley University, and Juan Garcia , a 21-year old Penn State undergraduate. One might imagine th...
Read more