Washington, Jun 15 (efe-epa).- The US Food and Drug Administration on Monday revoked its authorization for the emergency use of hydroxychloroquine, an anti-malaria drug, along with chloroquine, to treat seriously ill Covid-19 patients citing a lack of evidence that these drugs are effective in such cases.
The FDA’s chief scientist, Denise Hinton, announced the decision in a letter to the acting head of the Biomedical Advanced Research and Development Authority (BARDA), Gary Disbrow, on Monday.
“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19,” Hinton wrote, adding that it is “no longer reasonable” to believe that the drug combination’s benefits outweigh the potentially harmful side effects.
The FDA said that it does not believe that the proposed doses of the two medications will produce an anti-viral effect that could mitigate the effects of the coronavirus and the sometimes-deadly Covid-19 pneumonia it causes.
Also, the agency pointed out that recent data gathered in cases where the drugs had been used show that they do not reduce the mortality levels among Covid-19 patients or provide any other advantage, such as reducing the length of time they must remain in the hospital.
The FDA issued an authorization for the urgent use of the two meds in March for patients who were hospitalized with Covid-19 and those other patients who participated in clinical trials.
In April, the regulatory body warned physicians not to prescribe the drugs outside of a hospital setting.
Because hydroxychloroquine is approved in the US for treating illnesses such as lupus and arthritis, doctors can still administer it to coronavirus patients, but only if they are not specifically prescribing it for Covid-19.
However, the decision does not affect the ongoing clinical trials on the use of the med for Covid-19.
President Donald Trump has been one of the most enthusiastic promoters of hydroxychloroquine to treat – or ward off – the coronavirus, a stance that has created tensions within his administration. He even revealed that he was taking a daily dose of the med for two weeks to prevent his becoming infected with the virus, although he said all along that he was experiencing none of the flu-like symptoms associated with Covid-19.
Several recent studies have cast doubt on the effectiveness of hydroxychloroquine, including the prestigious British journal The Lancet, which on May 22 published a report incorporating data from hundreds of hospitals and involving 90,000 patients hospitalized for coronavirus infection around the world.
That report determined that the patients receiving either of the two drugs had a significantly higher risk of death than those who did not receive them.
A few days later, the World Health Organization announced that it had temporarily stopped clinical trials of hydroxychloroquine.
However, shortly thereafter, three of the authors of that WHO study decided to withdraw their names from it because of concerns about the veracity of the data and analysis presented in it.
The United States has suffered at least 115,827 Covid-19 deaths and 2.1 million confirmed coronavirus cases, according to the ongoing independent tally being kept by The Johns Hopkins University.