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

Published On : Tuesday Jun 16 2020

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

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.

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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.

Source:- techcrunch

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