The US Food and Drug Administration has warned of the risk of heart problems in patients taking two antimalarial drugs; that President Donald Trump has controversially touted as a potential treatment for COVID-19.
The US drug regulator on Friday said hydroxychloroquine and chloroquine; whether taken alone or in conjunction with the antibiotic azythromycin, could lead to heart rhythm problems for some patients.
Stephen Hahn, the FDA commissioner, said that while there were clinical trials assessing the safety of the drugs for COVID-19; there were “known side-effects”. He urged medical professionals to “closely screen and monitor” patients administered the drugs to help mitigate and the risks.
The warning came the day after Trump sparked criticism; suggesting that COVID-19 patients could kill the virus by ingesting disinfectant. On Friday, he claimed that the comment was a sarcastic effort to provoke reporters; adding that he knew disinfectants were only for sanitising skin.
“I was asking a question sarcastically to reporters like you just to see what would happen,” Trump said. “[Disinfectant] does kill it, and it would kill it on the hands, and it would make it much better.”
Also, Trump repeated his previous praise for hydroxychloroquine, saying he had just spoken to the president of Honduras; who told him the country had used the drug for COVID-19 and that “the results are so incredible.”
Trump has come under fire in recent weeks for touting drugs against the advice of his own public health advisers. He has also been attacked for trying to deflect blame for his handling of the crisis by faulting everyone; from China to the Democrats to the World Health Organization.
Earlier this week, the US National Institutes of Health contradicted another recommendation from Trump. It said coronavirus patients should not use a combination of hydroxychloroquine and azithromycin due to possible “toxicities”; meaning the risk of serious side effects, including poisoning.
The European Medicines Agency, which regulates drugs in the EU, issued a similar message on Thursday; about the “risk of serious side-effects”, including heart rhythm problems, in patients taking hydroxychloroquine and chloroquine and to treat COVID-19. A study published Friday in the Journal of the American Medical Association appeared to bolster those warnings. It cautioned against prescribing high doses of chloroquine diphosphate, after finding patients with severe COVID-19; were more likely to die after taking them.
Specifically, the study said higher doses of chloroquine appeared to result in patients with severe coronavirus dying.
It recommended that higher dosages not be given to critically ill patients with COVID-19 because of potential safety hazards; especially when taken with azithromycin and oseltamivir.
The president’s push for people to use hydroxychloroquine has already caused ructions in his own administration. This week, Rick Bright said he was dismissed as the director of the Biomedical Advanced Research and Development Authority; because of his doubts about the drug’s efficacy against COVID-19
Trump has sidestepped the controversy surrounding the claims raised by Mr Bright; by repeatedly saying that he knew nothing about the scientist.
The FDA has licensed hydroxychloroquine for use against malaria and has granted an emergency authorisation; for it to be used in clinical trials and in certain controlled hospital settings against COVID-19.
With additional notes from Financial Times