The U.S. Food and Drug Administration (FDA) has revoked an emergency use authorization (EUA) that it previously issued for chloroquine and hydroxychloroquine, two anti-malarial drugs also used in the treatment of chronic rheumatoid arthritis (via Washington Post). These are the drugs that Trump famously touted as effective in COVID-19 treatment, despite major concerns raised with the scientific validity of early medical investigations that showed they were potentially effective agains the infection beyond the ongoing global pandemic.
Subsequent studies showed conflicting results, including when one team of researchers ended elements of its clinical study into the drugs’ use early due to excess fatalities. The FDA had issued its EUA for use of chloroquine and hydroxychloroquine in late March, prompting criticism from many in the medical and pharmaceutical research community since evidence seemed very mixed in terms of its potential efficacy and risks. Then following those deaths in that subsequent clinical study, it issued a statement of precaution regarding the use of the drugs.
The FDA grants EUAs in circumstances where it deems the benefits outweigh the risks of expediting a provisional authorization for the use of therapies and devices that haven’t undergone its full, rigorous approval process for drugs and equipment. The COVID-19 pandemic has resulted in the FDA releasing many more EUAs than is typical, especially as it pertains to testing equipment used for diagnostic of the infection and SARS-CoV-19, its preceding and causal virus.
Trump irresponsibly touted the value of chloroquine and hydroxychloroquine, and later professed to be taking the medicine himself as a precaution he wrongly believed would stave off infection. The drug’s supply subsequently experienced a number of stresses due to increased demand, which had potentially dire consequences for people with a legitimate need for its consumption due to conditions for which it is approved and clinical shown to be effective, including lupus and chronic arthritis.
The U.S. Food and Drug Administration (FDA) has issued a new warning about the known side effects of hydroxychloroquine and chloroquine, two antimalarial drugs (also used in the treatment of chronic rheumatoid arthritis and lupus), on the same day that a group of researchers published a paper in the Journal of the American Medical Association about their termination of a study investigating the potential of chloroquine as a potential COVID-19 treatment.
The drugs can have dangerous side effects, and the study written about in the AMA journal was ended early because the “primary outcome” was the death of study participants, with 22 deaths resulting. Before it was abruptly ended, the researchers found a lethality rate of 39% in the group of its subjects who took high dosages, and 15% in the low-dosage group, with an overall lethality rate of 27%.
“Our study raises enough red flags to stop the use of a high-dosage regimen, because the risks of toxic effects overcame the benefits,” the researchers said in their findings.
The FDA’s alert on April 24 doesn’t make specific mention of this study, but the 81-person phase II clinical trial represents one of the largest to date. The FDA notice does advise that reports they have received of deaths in COVID-19 patients receiving hydroxychloroquine, either alone or in tandem with other drugs, including an antibiotic known as azithromycin (which all patients in the investigation published in the AMA journal were taking), can result in “abnormal heart rhythms such as QT interval prolongation, dangerously rapid heart rate called ventricular tachycardia and ventricular fibrillation, and in some cases, death.”
Hydroxychloroquine and chloroquine gained widespread attention because Donald Trump advocated them as likely effective treatments for COVID-19, despite a lack of significant scientific evidence or any clinical studies done about their safety, likely due to early, small-scale investigations that showed they might have some potential. He repeatedly touted the drugs as proven safe, since they have been cleared for use previously in treating other medical conditions, but didn’t appear to grasp that this does not mean they aren’t dangerous or perhaps deadly when taken in the context of other conditions, or for individuals with other risk characteristics.