The FDA cites recent data showing hydroxychloroquine and chloroquine offer no benefits for coronavirus patients.
An anti-malaria drug President Donald Trump touted as a treatment for COVID-19 has taken another hit, this time from the US Food and Drug Administration. A letter from FDA chief scientist Denise Hinton on Monday announced the agency is revoking the emergency use of oral formulations of hydroxychloroquine and chloroquine for treatment of the disease cause by the coronavirus.
The FDA in April cautioned against the use of hydroxychloroquine or chloroquine for COVID-19 outside of a hospital setting or clinical trial. The new directive is a more definitive closing of the door on its use for treating coronavirus patients.
The letter was in response to a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA), a government group charged with developing countermeasures for medical threats, including pandemics.
"Today's request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug's potential benefits for such use do not outweigh its known and potential risks," Hinton wrote in the letter.
The FDA originally issued the Emergency Use Authorization for hydroxychloroquine and chloroquine in late March. The revocation also takes into account serious concerns about the potential for cardiac-related side effects.
Hydroxychloroquine has been both studied and politicized as medical professionals look for ways to treat COVID-19. The World Health Organization suspended clinical trials of the drug in May, the same month Trump said he was taking it as a preventative measure.
"We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence," said the FDA's Anand Shah in a statement on Monday.