The U.S. Food and Drug Administration on Monday revoked the emergency use authorization for malaria drugs as a treatment for COVID-19 amid growing evidence they don’t work and could cause deadly side effects.
U.S. President Donald Trump had championed the use of the drugs for COVID-19 and even said he had taken them himself.
But the FDA said based on new evidence, it was no longer reasonable to believe that oral formulations of hydroxychloroquine and the related drug chloroquine may be effective in treating the respiratory illness caused by the novel coronavirus.
The move comes after several studies of hydroxychloroquine suggested it was not effective, including a widely anticipated trial earlier this month showed it failed to prevent infection in people who have been exposed to the virus.
The drug’s anti-inflammatory and antiviral properties suggested it might help treat COVID-19, and the FDA authorized its emergency use in March at the height of a pandemic caused by a virus for which there were no approved treatments.
Trump pushed drug’s use
Trump aggressively pushed the drug beginning in the first weeks of the outbreak and stunned medical professionals when he revealed he took it preemptively against infection after two people who worked at the White House were diagnosed with COVID-19.
At the White House Monday, Trump said other countries had provided great reports on the effectiveness of hydroxychloroquine for treatment of the coronavirus, complaining that only U.S. agencies have failed to grasp its benefit.
The move means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities. The drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.
But doctors in recent weeks had already pulled back on the use of hydroxychloroquine as a COVID-19 treatment after several studies suggested it is not effective and may pose heart risks for certain patients.
Current U.S. government treatment guidelines do not recommend use of the malaria drugs for COVID-19 patients outside of a clinical trial.
The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.
Some clinical trials still ongoing
France, Italy and Belgium late last month moved to halt the use of hydroxychloroquine to treat COVID-19 patients. But the United States last month supplied Brazil with two million doses for use against the coronavirus, as the South American country has emerged as the pandemic’s latest epicentre.
Meanwhile, some 400 trials are listed as using hydroxychloroquine or chloroquine as interventions for COVID-19, more than half of them still ongoing, according to a recent analysis from research firm GlobalData.
In the United States, the National Institute of Allergy and Infectious Diseases last month launched a trial designed to show whether hydroxychloroquine in combination with azithromycin can prevent hospitalization and death from COVID-19.