FDA rescinds emergency authorization of hydroxychloroquine and chloroquine

The scientific community kept giving hydroxychloroquine one more chance. And the highly touted drug just kept losing. As the evidence against it mounted, it failed its biggest chance yet, and the FDA finally invoked the mercy rule.

Hydroxychloroquine is an antimalarial drug that has received a lot of high profile attention as a possible treatment for COVID-19. Several hospitals have offered it, often in combination with azithromycin, to COVID-19 patients. It has long been denied that the available science supports its use (Lancet 2020;doi:doi.org/10.1016/S0140-6736(20)30817-5). But science kept giving it another chance. In the U.S., an emergency use authorization permitted the use of hydroxychloroquine and chloroquine in adults and adolescents who weigh at least 50 kg. But, the FDA has now revoked even that emergency use authorization.

Hydroxychloroquine failed in study after study to justify the claims on its resume that its benefit for COVID-19 outweighed its risks. Then researchers gave it what turned out to be one final chance. This time, for the very first time, the study was a double-blind, placebo-controlled study.

The study was conducted in Canada and the United States. Everyone in the study had been exposed to COVID-19. They had all been exposed to someone with confirmed COVID-19 at a distance of less than six feed for more than ten minutes. That means that all of them could have caught the virus. 87.6% of them were at high risk because they were wearing neither a mask nor an eye shield; the rest were at moderate risk because they were wearing a mask but no eye shield.

Every person in the study was put on either a placebo or hydroxychloroquine within four days of being exposed to the virus. It didn’t make a difference which treatment they were given. There was no significant difference between the number of people who became infected in the two groups. 14.3% of the placebo group came down with COVID-19, and 11.8% of the hydroxychloroquine group became infected. The appearance of a small benefit was not statistically significant. Though there was no benefit, there were more side effects in the hydroxychloroquine group: 40.1% of people suffered a side effect versus 16.8% on the placebo.

The researchers concluded that, when someone is exposed to COVID-19, hydroxychloroquine does not prevent them from getting the virus (NEJM 2020;doi:10.1056/NEJMoa2016638).

And that, it seems, was enough for the FDA. On June 16, 2020, the FDA rescinded its emergency authorization of hydroxychloroquine and chloroquine. In its memorandum of explanation, the FDA said that “it is unlikely that CQ [chloroquine] or HCQ [hydroxychloroquine] may be effective in treating COVID-19. Further, in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia in COVID-19 patients, the Agency has concluded that the known and potential benefits of CQ and HCQ do not outweigh the known and potential risks for the authorized uses.


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