COVID-19: US withdraws emergency use of Trump's 'miracle' drug hydroxychloroquine
Based on new evidence, the FDA said it was no longer reasonable to believe that hydroxychloroquine and chloroquine may be effective in treating COVID-19.
Controversial anti-malaria drug hydroxychloroquine has been in the spotlight since it was touted by US President Donald Trump as a "game changer" in battle against the novel coronavirus, but now its emergency use as a treatment for COVID-19 has been withdrawn by the US Food and Drug Administration (FDA).
The FDA said that new evidence from clinical trials showed that it was no longer reasonable to believe that the drug would produce an antiviral effect. Citing reports of heart complications, the agency said that hydroxychloroquine and the related drug chloroquine pose a greater risk to patients than any potential benefits.
Still Trump defended promoting the use of hydroxychloroquine to treat the highly-contagious virus.
The US FDA move comes after several studies of the decades-old malaria drug suggested it was not effective, including a widely anticipated trial earlier this month that showed it failed to prevent infection in people who had 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 for which there were no approved treatments.
While it did appear to neutralize the virus in laboratory experiments, hydroxychloroquine, which is also used to treat lupus and rheumatoid arthritis, has failed to prove its worth in human COVID-19 trials, thus far.
In March, Trump said hydroxychloroquine used in combination with the antibiotic azithromycin had "a real chance to be one of the biggest game changers in the history of medicine," with little evidence to back up that claim.
He later said he took the drugs preventively after two people who worked at the White House were diagnosed with COVID-19, and he urged others to try it.
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 US government treatment guidelines do not recommend use of the malaria drugs for COVID-19 patients outside of a clinical trial.
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 2 million doses for use against the coronavirus, as the South American country has emerged as the pandemic's latest epicentre.
Responding to the FDA's decision, Trump said that he had previously taken the drug preventatively with no side effects. "I took it and I felt good about taking it," he told reporters on Monday, adding: "I can't complain about it, I took it for two weeks, and I'm here, here we are."
The 74-year-old President said that many people had told him it had saved their lives.
FDA WARNS AGAINST HCQ REMDESIVIR COMBINATION
The US FDA also issued a warning to healthcare providers against administering hydroxychloroquine or chloroquine in combination with Gilead Sciences' experimental COVID-19 drug remdesivir. The agency, based on data from a recent non-clinical study, said the co-administration may result in reduced antiviral activity of remdesivir.
It also added it had no such evidence from a clinical setting and that it continues to evaluate all data related to remdesivir.
Hydroxychloroquine is used to treat lupus and rheumatoid arthritis as well as malaria. Leading doctors say the drug can cause severe side effects, and can even throw off the process that makes the heart beat in time.
The long list of common side effects of the malaria drug include slow heartbeat, nausea, vomiting, mental/mood changes, stomach pain or cramps, loss of appetite, weight loss, diarrhea, dizziness, spinning sensation, headache, ringing in the ears, nervousness, irritability, skin rash, itching or hair loss.
Trials around the world were temporarily derailed when a study published in reputed journal The Lancet claimed the drug increased fatalities and heart problems in some patients. The results prompted the World Health Organization (WHO) and others to halt trials over safety concerns.
However, The Lancet subsequently retracted the study when it was found to have serious shortcomings and the WHO has resumed its trials.
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.