The U.S. Food and Drug Administration (FDA) has officially canceled its decision to use chloroquine and hydroxychloroquine to treat people hospitalized with COVID-19 under an Emergency Use Authorization (EUA).
The agency announced the EUA of the malarial drugs on March 28 for the treatment of COVID-19, the infection caused by the new coronavirus.
The FDA said in a statement, “Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.”
The U.S. drug regulatory body has also warned that the use of these drugs could lead to potential drug interaction with experimental antiviral drug remdesivir, limiting its efficacy against COVID-19. The FDA granted EUA for remdesivir on May 1.
“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir,” the FDA said.
“The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” it added.
President Donald Trump has been promoting the use of hydroxychloroquine to treat COVID-19; however, scientific studies raised many questions about the drug’s safety and efficacy. One study pointed out the potential cardiovascular risk factors associated with hydroxychloroquine.
Acknowledging this recent evidence, the FDA said, “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
The FDA’s Safety Communication has warned against the use of chloroquine and hydroxychloroquine outside of a hospital setting, citing “reports of serious heart rhythm problems.” Dr. Patrizia Cavazzoni, acting director of Center for Drug Evaluation and Research (CDER), noted, “While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate, based on a rigorous assessment by scientists in our CDER.”
