Agency says criteria for EUA no longer met

WASHINGTON — Based on a review of information emerging from clinical trials, the FDA revoked the emergency use authorization (EUA) for hydroxychloroquine and chloroquine as a treatment for Covid-19.

The revocation is a stunning turn of events for a treatment that was touted as a game-changer in the Covid-19 pandemic.

The FDA is responding to a request from Gary Disbrow, PhD, Deputy Assistant Secretary and Director of the Medical Countermeasure Programs of the Biomedical Advanced Research and Development Authority (BARDA). The EUA was issued on March 28 to allow hydroxychloroquine and chloroquine for compassionate use in certain settings for the treatment of patients with Covid-19.

However, the drugs came under scrutiny as studies failed to show benefit from the malaria drugs in the treatment of Covid-19. Chloroquine and hydroxychloroquine failed as a prophylactic treatment, were found to cause QT prolongation in some patients, and — while the EUA was still in effect — the FDA warned about heart rhythm problems.

Nonetheless, hydroxychloroquine was touted by President Donald J. Trump as an effective treatment; he also claimed that he took the drug after he was exposed to Covid-19.

In revoking the EUA, the FDA said that their review found the drugs no longer met the criteria for EUA. In a Boxed statement on its original EUA Fact sheet, the agency noted that:

“Based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat Covid-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met. Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating Covid-19 for the authorized uses in the EUA. 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.”

This announcement most likely signals a death knell for hydroxychloroquine’s use for Covid-19, and many states are now left with stockpiles of millions of doses of the drug.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,254,930,570,574,183,190,926,192,927,151,725,928,925,934