While the drugs are not currently FDA-approved for COVID-19, the FDA noted that they are recommended in some countries for COVID-19.
The FDA issued an emergency use authorization (EUA) on Saturday for the antimalarial drugs hydroxychloroquine sulfate and chloroquine phosphate for the treatment of patients with coronavirus disease 2019 (COVID-19).1
While the drugs are not currently FDA-approved for COVID-19, the EUA letter from the FDA noted that they are recommended in some countries for COVID-19, based on limited in-vitro and anecdotal clinical data. The letter added that participation in randomized controlled clinical trials on the drugs’ efficacy in COVID-19 is encouraged.1
Denise Hinton, MS, chief scientist at the FDA, said in the letter that the EUA was based on 3 criteria. Firstly, Hinton noted that severe acute respiratory syndrome coronavirus (SARS-CoV-2) can cause serious or life-threatening disease, including severe respiratory illness, to those infected. Secondly, based on the limited evidence it is reasonable to believe that the drugs may be effective in COVID-19, and that the known and potential benefits outweigh the known and potential risks. Finally, Hinton noted the lack of an adequate, approved, and available alternative to the emergency use of these drugs.1
The FDA previously granted Expanded Access—or “compassionate use”—status to chloroquine, as well as the investigational drug remdesivir, for treating patients with COVID-19. Under compassionate use, these drugs were indicated for patients with serious or life-threatening cases of the virus.2
According to the scope of the EUA, the drugs must be administered by a health care provider pursuant to a valid prescription of a licensed health care practitioner, and may only be used in adult and adolescent patients who weigh 50 kg or more and are hospitalized with COVID-19.1
The Strategic National Stockpile will distribute the drugs and maintain records of its distributions. Health care facilities who receive them must track adverse events and report any to the FDA. They must also maintain records about the dispensed hydroxychloroquine and chloroquine, including lot numbers, quantity, and receipt date.1
The EUA will remain in effect until the FDA declares that the circumstances no longer warrant emergency use of the drugs.1