FDA withdraws emergency use authorization for hydroxychloroquine

The Food and Drug Administration (FDA) has withdrawn the emergency use authorization for two controversial coronavirus treatment drugs promoted by President Trump because of serious safety issues.

The agency said recent clinical trial failures mean chloroquine and hydroxychloroquine may not be effective at treating COVID-19 or preventing it in people who have been exposed, and that their potential benefits do not outweigh the risks.

Doctors have warned that the drugs can cause serious heart problems, but the FDA had previously allowed their use for hospitalized patients and during clinical trials.

Trump spent weeks promoting the drugs as a potential miracle treatment for COVID-19, despite scant evidence. The FDA then issued the emergency use authorization in March. Critics accused the agency of caving to pressure from the administration, which the FDA has denied.

In April, roughly a month after issuing the emergency authorization, the agency warned against using hydroxychloroquine outside of hospitals and clinical trials because of the risk of potentially fatal cardiac problems.

Last month, Trump said he had been taking hydroxychloroquine, in combination with zinc, as a way to prevent getting COVID-19 after a White House aide was diagnosed with the disease, which is caused by the novel coronavirus. He said he felt fine after finishing the regimen, and even said he would take the drugs again if he was ever exposed to coronavirus. 

“I think it gives you an additional level of safety,” Trump said at the time, downplaying the warnings that the drug can cause significant heart problems. 

Trump’s promotion of the drugs has led to shortages for people that need it for other conditions. Hydroxychloroquine, which was initially approved as an anti-malaria drug, is also used to treat lupus and rheumatoid arthritis. 

In revoking the emergency authorization, FDA noted that recent data from a large randomized controlled trial showed no difference between using hydroxychloroquine and standard COVID treatment alone. 

However, because the drugs are on the market and approved for other uses, it could still be prescribed for “off-label” use in COVID patients. Clinical trials studying the drugs can also continue. The World Health Organization and the National Institutes of Health are still conducting trails.

The administration’s embrace of hydroxychloroquine allegedly led to the ouster of Rick Bright, who led the Biomedical Advanced Research and Development Authority (BARDA) and oversaw federal efforts to find a vaccine and treatment for the coronavirus. 

Bright filed a whistleblower complaint claiming he was demoted and reassigned after he refused to promote the drug’s widespread use. 

Bright initially wrote to FDA to authorize the emergency use, a move he now claims he made under duress. 

The revocation of the emergency use authorization comes after a request from Gary Disbrow, the current acting director of BARDA who succeeded Bright. 

–This report was updated at 12:21 p.m.