FDA ends emergency use authorisation of hydroxychloroquine, chloroquine for COVID-19

The US Food and Drug Administration has revoked emergency use authorisation of drugs chloroquine phosphate and hydroxychloroquine to treat COVID-19 patients.

The agency said the drugs did not decrease mortality nor did they speed up the recovery of the patients.

“In light of ongoing serious cardiac adverse events and other potentially serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorised use,” said the FDA in a statement on Monday.

Emergency use was allowed by the agency on March 28. However, results from ongoing trials showed no significant benefit in hospitalised patients. The FDA added that hydroxychloroquine administered with another experimental drug remdesivir, an antiviral, reduced the effect of remdesivir.

In April the regulatory authority had warned against using HCQ in any setting other than carefully controlled clinical trials.

Research had also shown that HCQ and chloroquine were not effective in preventing COVID-19 from developing in uninfected patients. However, withdrawal of the EUA does not mean doctors can’t prescribe the drugs.

This news comes after the World Health Organisation announced that it was reviewing hydroxychloroquine use in its global COVID-19 treatment Solidarity Trial.

The trial was halted in May after a controversial study was published in The Lancet claiming HCQ was unsafe for COVID-19 patients. It had resumed after that study was retracted.

Chloroquine and hydroxychloroquine are used to treat or prevent malaria. Hydroxychloroquine is also used for autoimmune disorders such as lupus in adults and rheumatoid arthritis. 

Taking the drug without being prescribed by a doctor can result in serious side effects including heart failure, anaphylactic shock, unusual bleeding and disturbing thoughts.