Emergency Use of Hydroxychloroquine for COVID-19 Rescinded By FDA

Following growing health concerns over the side effects of hydroxycholoquine and lack of evidence that it is effective at treating COVID-19, federal regulators have revoked a special emergency order that allowed the use of the malaria drug in response to the coronavirus pandemic.

On Monday, the FDA issued a press release announcing that it has revoked an emergency use authorization which allowed chloroquine phosphate and hydroxychloroquine sulfate to be used to treat patients hospitalized with COVID-19 when a clinical trial is unavailable.

The move came after the agency determined the drugs are unlikely to be effective in treating COVID-19, and due to reports of ongoing serious cardiac adverse events experienced by patients.

In a letter revoking the authorization, the FDA indicated the known and potential benefits of the drugs do not outweigh the adverse health risks.

The FDA can issue emergency use authorizations to allow the use of unapproved drugs, or drugs not approved for that particular purpose, in emergency situations to treat life-threatening diseases or conditions, including the virus that causes COVID-19.

On February 4, 2020, the Health and Human Services Secretary determined the public health emergency posed significant potential to affect national security or the health and security of U.S. Citizens. That emergency determination allowed for the emergency use authorization for hydroxychloroquine and other health and safety measures.

The FDA first granted the emergency use authorization for hydroxychloroquine on March 28, 2020, based on the “science and data available at the time” to combat the worsening COVID-19 pandemic in the absence of a treatment or vaccine. The FDA now indicates it is rescinding the authorization based on “up to date science and data.”

Later, as the findings from new research was reported, the World Health Organization halted a clinical trial early due to findings suggesting hydroxychloroquine may increase the risk of death among COVID-19 patients. It later resumed that study.

The U.S. Centers for Disease Control and Prevention (CDC) and the FDA had to issue a warning to the public not to use hydroxychloroquine without the oversight of a health care professional in a hospital setting. The health advisory came after President Donald Trump publicly endorsed the drug, leading some citizens to try it and becoming severely ill, resulting in at least one death.

“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” Dr. Anand Shah, FDA Deputy Commissioner for Medical and Scientific Affairs, said in the press release. “The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available.”