(Reuters) - The malaria drug hydroxychloroquine, which U.S. President Donald Trump says he has been taking and has urged others to use, was tied to increased risk of death in hospitalized COVID-19 patients, according to a large study published in the medical journal Lancet.
In the study https://www.thelancet.com/lancet/article/s0140673620311806 that looked at over 96,000 people hospitalized with COVID-19, those treated with hydroxychloroquine or the related chloroquine had higher risk of death than patients who were not given the medicines.
The authors said they could not confirm if taking the drug resulted in any benefit in coronavirus patients.
"Urgent confirmation from randomized clinical trials is needed," they wrote. This study was not a placebo-controlled trial.
Demand for decades-old hydroxychloroquine has surged as Trump repeatedly pushed for its use against the coronavirus, urging people to try it. "What have you got to lose," he said.
This week, Trump said he has been taking hydroxychloroquine as a preventative medicine, despite a lack of scientific evidence.
The Lancet study authors suggested the medicines should not be used to treat COVID-19 outside of clinical trials until those studies confirm their safety and efficacy for COVID-19 patients.
The U.S. Food and Drug Administration has said hydroxychloroquine should only be used for hospitalized COVID-19 patients or those in clinical trials. The drug has been tied to dangerous heart rhythm problems.
The Lancet study looked at data from 671 hospitals, where 14,888 patients were given either hydroxychloroquine or chloroquine, with or without the antibiotic macrolide, and 81,144 patients who were not treated with those drugs.
