The Food and Drug Administration has rescinded authorizations for hydroxychloroquine and chloroquine, promoted by President Trump as coronavirus treatments, as evidence begins to show the drugs may be harmful.
“We now believe that the suggested dosing regimens for [ hydroxychloroquine and chloroquine] as detailed in the Fact Sheets are unlikely to produce an antiviral effect,” FDA Chief Scientist Denise Hinton said Monday.
The FDA was responding to a request to revoke emergency use authorization for the drugs from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority, the government agency tasked with finding COVID-19 treatments.
The FDA decided that, amid mounting evidence that hydroxychloroquine is not an effective antiviral treatment, the drugs, generally used to treat lupus and rheumatoid arthritis, can only be administered in clinical trials. However, because the drugs are approved to treat other conditions, doctors are still able to prescribe the drugs “off label” to treat COVID-19.
“FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” Hinton said.
[Click here for complete coronavirus coverage]
The drugs will no longer be used to treat hospitalized COVID-19 patients, having been approved for use in hospital settings by the FDA in March. National Institutes of Health guidelines also discourage use of the drugs outside of clinical trials. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at NIH, said in May that it’s “quite evident” that hydroxychloroquine is not an effective coronavirus treatment.
Meanwhile, Trump has touted the benefits of taking hydroxychloroquine as a prophylactic, despite public health officials saying otherwise. He said in May that he had been prescribed the drug as a preventive measure, telling reporters, “I’ve heard a lot of good stories.” After promoting the drug for several weeks in March, prescriptions for the drugs skyrocketed.
A study published in May by the Journal of the American Medical Association found that from March 15 to March 21, prescriptions for a 30-day supply of hydroxychloroquine surged 1,977%, from 2,208 to 45,858. It also found that prescriptions for a 30-day to 60-day supply jumped 179%, from 70,472 to 196,606.
After the FDA granted the drugs Emergency Use Approval on March 28, drug manufacturers such as Bayer and Novartis donated 30 million doses of the drug to the Strategic National Stockpile. The Department of Health and Human Services will no longer accept donations of the drug to add to the stockpile.