The Food and Drug Administration (FDA) has issued an emergency use authorization for chloroquine and hydroxychloroquine for coronavirus cases on Sunday, according to Politico. The two compounds have previously been used against dire COVID-19 infections, but there is still little evidence that they’re safe and that they work.
The agency allowed for these drugs 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,” according to a statement from the U.S. Department of Health and Human Services. At least 30 million doses of and 1 million doses of chloroquine have been donated to the stockpile so far by pharmaceutical companies Sandoz and Bayer.
Untested measures
The two drugs were initially developed to fight malaria, but have recently been touted as a possible treatment against COVID-19 — however, their efficacy and safety in this role are still under investigation. Still, the FDA’s move to allow these drugs to be used in clinical settings was supported by the White House, with President Trump saying that we’ll “see how it works. It may. It may not”.
The FDA has already allowed New York state to test the medication on seriously ill patients, and some hospitals have added it to their treatment protocols. Experts, however, are concerned over the effort, noting that we lack data on whether the drug actually works on coronaviruses and that it could gobble up resources from other patients who need the medication. A more efficient course of action would be to run chloroquine and hydroxychloroquine through clinical tests to first determine their efficacy. Meanwhile, the FDA hopes that their announcement will allow more manufacturers to produce and donate these drugs, which would help more patients access them.
Hydroxychloroquine is available commercially in the United States and used to treat malaria, lupus, and rheumatoid arthritis. The drug is currently being promoted as a cure for the coronavirus by certain political and media figures, but with little scientific research to back the claim. However, a growing number of lupus and arthritis patients have complained that they’ve been unable to fill their prescriptions amid ongoing shortages. Chloroquine, a related compound and also an antimalaria drug, has also been touted as a potential cure for the virus.
President Trump has irresponsibly (because there’s no data to back the claim up) called these two drugs “game-changers” in the fight against COVID-19. So far, this has led to the hoarding of the drugs and at least one death in the US. Even veterinary-grade chloroquine is being hoarded and used by an increasingly anxious public, which is strongly discouraged and potentially deadly, according to the FDA.