The FDA Revokes Its Emergency Use Authorization for Hydroxychloroquine
https://www.wired.com/story/the-fda-revokes-its-emergency-use-authorization-for-hydroxychloroquine/
After months of debate and intense research concerning hydroxychloroquine, on Monday FDA officials revoked their Emergency Use Authorization (EUA) for the anti-malarial drug that President Donald Trump has promoted in the fight against Covid-19. When the EUA was issued in late March, no high-quality studies of the drug’s ability to prevent and treat Covid-19 were yet available. Now, a handful of randomized trials have failed to find any benefit associated with hydroxychloroquine use.
On the basis of the current research, hydroxychloroquine “may not be effective to treat COVID-19,” and its “potential benefits for such use do not outweigh its known and potential risks” wrote Rear Admiral Denise Hinton, the FDA’s chief scientist, in a letter revoking the EUA. An attached memorandum in support of the agency’s decision cited several recent studies—including one of Covid-19 patients in China and one with US and Canadian participants who had been exposed to the virus—that found no positive effect from hydroxychloroquine use. At the doses permitted under the EUA, FDA officials concluded, hydroxychloroquine is unlikely to help treat or prevent infection from the novel coronavirus.