FDA Terminates Emergency Use Authorization Of Hydroxychloroquine To Treat Covid-19

Modesto Morganelli
Июня 16, 2020

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.

The US Food and Drug Administration (FDA) has announced that it has revoked the emergency use authorisation (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalised patients with COVID-19. In April, former FDA leaders decried the agency's decision to authorize emergency use of the drugs, asserting it was based on political pressure, not scientific evidence. The drugs are still available for alternate uses, so USA doctors could still prescribe them for COVID-19 - a practice known as off-label prescribing. Chloroquine and hydroxychloroquine failed as a prophylactic treatment, were found to cause QT prolongation in some patients, and - while the EUA was still in effect - the FDA warned about heart rhythm problems. It will remain available for its previously approved conditions, which include rheumatoid arthritis and systemic lupus erythematosus as well as malaria, and can still be prescribed off-label at physicians' discretion. However, it is unfortunately associated with serious side effects such as heart arrhythmia.

The decision comes after the FDA reviewed emerging scientific data which indicate that neither of the drugs are likely to be effective in treating Covid-19. According to the FDA, the totality of scientific evidence now available indicate a lack of benefit.

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.

President Trump has been advocated for the drugs effectiveness since late March, and has also claimed to have been taking the drug himself.

In March, the FDA granted the emergency use of the drug for some serious cases.

The FDA ruling also came despite Trump's frequent praise of the drug's usefulness for staving off the disease. It said that both meet FDA benchmarks to treat or prevent malaria, but not COVID-19.

Whitsett said she heard about the drugs during a press conference held by Trump.

"I think it gives you an additional level of safety", he said at the time, according to The Hill. "We continue to look at the data on hydroxychloroquine and chloroquine and we will make future determinations on these products based on available evidence including ongoing clinical studies", Hanh wrote in the letter.

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