Two anti-malaria drugs touted by President Trump as a potential way to treat the novel coronavirus are now in shortage, the Food and Drug Administration (FDA) said Wednesday.
Hydroxychloroquine and chloroquine were both added to the agency’s drug shortages list on Tuesday “due to a significant surge in demand.”
All manufacturers are ramping up production, FDA said, and it is working with them “to ensure this can happen expeditiously and safely.”
The FDA granted the drugs an emergency use authorization Sunday, and allowed them to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.”
Some small overseas studies found that the drugs could be used as a way to treat COVID-19, sparking a massive uptick in demand, but experts in the U.S. are skeptical of the evidence.
“I’m not that optimistic about hydroxychloroquine. It’s not really clear it’s having a clinic effect,” former FDA Commissioner Scott Gottlieb said Wednesday. “I hope it works, but I think a lot of the enthusiasm is because it’s available, so people are over-interpreting the data, because it’s on the shelf.”
Still, Trump has been pushing for the FDA to speed up the off-label use of the drugs for COVID-19, and the agency has already allowed New York to begin distributing the drugs to seriously ill patients as part of an “observational” trial.
The push from the White House has raised concerns from medical experts that the drugs could be siphoned away from people who need them.
Hydroxychloroquine, which is already available commercially in the United States, is commonly used to treat malaria, lupus and rheumatoid arthritis. Chloroquine is generally prescribed less often than hydroxychloroquine because its side effects can be more dangerous.
Several states have instituted policies to prevent people from hoarding the drugs.
The FDA said Sandoz has donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine. Use of the donated medications is expected to help ease supply pressures for the drugs, the FDA said.