«Accordingly, FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19,» Hinton wrote in the letter, using abbreviations for hydroxychloroquine and chloroquine. «As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by FDA to treat COVID-19.»
Doctors can continue to legally prescribe the drugs off-label, as they can with any drug that’s approved for other conditions. The FDA’s emergency use authorization for hydroxychloroquine and chloroquine was narrow in scope, applying only to hospitalized Covid-19 patients and only to drugs donated to the Strategic National Stockpile.
The FDA on Monday also warned against giving chloroquine or hydroxychloroquine to patients who are also getting remdesivir, the one drug that has any authorization for use in treating coronavirus.
Mixing remdesivir, an infused antiviral drug made by Gilead Sciences Inc., and either controversial drug could reduce the effectiveness of remdesivir, the FDA warned.
«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,» the FDA said.
In an open letter published late last month, FDA commissioner Dr. Stephen Hahn appeared to defend the agency’s decision to issue the authorization.
«This decision was based on evaluation of the EUA criteria and the scientific evidence available at that time. We continue to look at the data on hydroxychloroquine and chloroquine and we will make future determinations on these products based on available evidence including ongoing clinical studies,» Hahn said in the letter last month.
The emergency use authorization, or EUA, made it easier for pills donated to the national stockpile to be distributed to coronavirus patients.
Hahn added in the letter that «we also knew it was important to help ensure a stable supply of the drugs for patients with lupus and rheumatoid arthritis given the increased demand.»
In an interview with CNN last month, Hahn also defended his agency’s handling of hydroxychloroquine. He acknowledged the political climate surrounding the drug, but said, «I stand by our decisions because I think they are rooted in science and data, and we’ll continue to reevaluate.»
This story has been updated to include additional background information.
CNN’s Devan Cole contributed to this report.