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The US Food and Drug Administration (FDA) have withdrawn their emergency use authorisation for the drugs hydroxychloroquine and chloroquine for treating COVID-19.
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine (LSHTM), said:
“The emerging evidence, especially from the RECOVERY trial, suggests that treatment of hospitalised patients with hydroxychloroquine does not offer any benefit and the known harms, though they occur rarely, are such that, outside of a randomised trial, mean that the benefit-harm balance is tilted towards harm.
“As was stated ten days ago [https://www.sciencemediacentre.org/expert-reaction-to-the-recovery-trial-reporting-no-clinical-benefit-from-use-of-hydroxychloroquine-in-patients-admitted-to-hospital-with-covid-19/] the RECOVERY trial was well-conducted and was large enough to detect a notable benefit if there had been one.
“The US agencies concerned with granting Emergency Use Authorisations have reacted appropriately to the current evidence. There should be more data from essentially similar randomised trials becoming available over the next month or two. The totality of the evidence will then show whether the effect of hydroxychloroquine in treating patients unwell enough to be treated in hospital is clearly in the direction of harm or simply no effect. There is as yet no strong evidence that hydroxychloroquine is harmful in this context so it is reasonable to continue randomised trials, but it would be sensible if all the trialists could examine their data to produce consensus as soon as possible.
“The current data do not show directly whether hydroxychloroquine could be effective in preventing, or reducing the severity of, Covid-19. It does make it less likely that benefit will be seen for prevention, but until the randomised trials on this different question are published, there remains some uncertainty. The randomised trials should continue unless convincing evidence of harm appears.
“This action should prevent the use of hydroxychloroquine for treating patients in hospital with Covid-19 outside a randomised trial; whether it will do so or not is uncertain, but it will almost undoubtedly further reduce the likelihood of its use for this purpose.
“It does not mean that hydroxychloroquine should be stopped when it is used in its authorised indications of auto-immune disease and malaria where its benefits are known and outweigh any harms.
“In addition to the full explanation in its letter of revocation, the FDA has produced useful Q&As for patients and prescribers.
https://www.fda.gov/media/138946/download”
https://www.fda.gov/media/138945/download
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