The U.S. Food and Drug Administration (FDA) has revoked its emergency use authorization for the malaria drugs hydroxychloroquine and chloroquine for the treatment of COVID-19 in hospitalized patients. After reviewing the current research available on the drugs, the FDA determined that the drugs do not meet the statutory criteria for emergency use authorization (EUA). The drugs are unlikely to be effective in treating COVID-19, the agency said on its website on Monday.
“Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19,” it noted.
Earlier the FDA had issued a warning saying that the malaria drugs could cause heart arrhythmias (irregular heartbeat) in COVID-19 patients.
On Monday, the agency also warned against giving chloroquine or hydroxychloroquine to patients who are also receiving remdesivir, an infused antiviral drug made by Gilead Sciences Inc. It cautioned that mixing remdesivir with either of the malaria drug could reduce the effectiveness of remdesivir. However, it will not affect FDA-approved uses of these drugs for malaria, lupus, and rheumatoid arthritis, the agency noted.
WHO’s Solidarity Trial
The World Health Organization (WHO) had temporarily suspended the solidarity trial of hydroxychloroquine on May 25 after a study warned that it can cause more fatalities among COVID-19 patients. After reviewing its own available data, the UN health agency resumed the programme in the first week of this month.
At a press conference in the WHO headquarters in Geneva earlier this month, Director General Tedros Adhanom Ghebreyesus had announced that they will continue all arms of the solidarity trial, including hydroxychloroquine.
“On the basis of the available mortality data, the members of the committee recommended that there are no reasons to modify the trial protocol. The Executive Group received this recommendation and endorsed continuation of all arms of the solidarity trial, including hydroxychloroquine,” IANS had quoted the WHO chief as saying
However, the WHO said on Monday that it is still reviewing the use of hydroxychloroquine in its Solidarity Trial.
Study link HCQ To Increased Mortality Rate
US President Donald Trump has been strongly advocating the use of hydroxychloroquine as a potential treatment and prevention measure against COVID-19. He even revealed last month that he is taking the drug, which he calls a game-changer, as a preventive measure against COVID-19 infection.
However, a study published in the Lancet study found increased number of deaths in patients treated with hydroxychloroquine in hospitals around the world. Based on their finding, the scientists had warned against the use of this malaria drug and its older version, chloroquine, to COVID-19 patients except in proper research settings.
The study reviewed data of more than 96,000 COVID-19 patients in 671 hospitals, taking one of the anti-malaria drugs, with or without an antibiotic such as azithromycin, between 20 December and 14 April. It found that one in six of those taking one of the drugs died and many patients treated with hydroxychloroquine also developed heart irregularities.