The FDA rescinded its emergency use authorization (EUA) of hydroxychloroquine (HCQ) to treat COVID-19 patients, citing concerns about efficacy and risks associated with its use, and saying the drug no longer meets the criteria for an EUA, the agency said on Monday.
A brief paragraph at the bottom of the FDA’s emergency use authorization page noted that the FDA has determined that based on continued review, the “statutory criteria” for an emergency use authorization are no longer met. The agency went on to say both hydroxychloroquine a related antimalarial drug, chloroquine (CQ), are “unlikely to be effective at treating COVID-19” for uses described in the EUA.
Moreover, the FDA now says the benefits of the drug “no longer outweigh the potential risks,” citing the serious cardiac adverse events associated with the drug.
“This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19,” the agency said.
A letter from the agency to the Biomedical Advanced Research and Development Authority (BARDA) detailed the FDA’s concerns, including that suggested dosing regimens are “unlikely to produce an antiviral effect,” and said “decreased viral shedding” from treatment with these drugs, noted in some observational studies, “has not been consistently replicated.”
While current FDA guidelines did not recommend use of the drugs outside of a randomized clinical trial, the FDA also pointed to recent data from a large clinical trial showing no “evidence of benefit” for mortality, effect on hospital length of stay, or need for mechanical ventilation among COVID-19 patients treated with hydroxychloroquine.
The FDA originally granted an EUA to HCQ on March 28, 2020.
This may be the end for the controversial drug as COVID-19 therapy; study after study found no benefit in the drug among hospitalized patients or as post-exposure prophylaxis. It will remain available for its previously approved conditions, which include rheumatoid arthritis and systemic lupus erythematosus as well as malaria, and can still be prescribed off-label at physicians’ discretion. Without the EUA, however, third-party reimbursement may become harder to secure for COVID-19 cases, and malpractice litigation easier to win if patients suffer adverse events.
A Frequently Asked Questions document released by the agency noted that patients currently being treated with HCQ can finish their treatment course, “to the extent found necessary by the patient’s attending physician.” The document added that clinical trials studying HCQ and CQ to see if the drugs can benefit patients with COVID-19 will continue.
Last Updated June 15, 2020
Source: MedicalNewsToday.com
