COVID-19: FDA cancels emergency approval of controversial antimalarial drugs
Aside from the lack of notable improvements in patient recovery, there is growing evidence that shows the possibility of serious side effects.
After being lauded by doctors in the early days of the 2019 novel coronavirus outbreak, hydroxychloroquine and chloroquine were used to treat COVID-19 patients. Despite the inherent dangers it brings to the table if used without medical supervision, data shows a remarkable spike in demand and usage of the drugs. Clinical studies were launched at the request of concerned healthcare professionals, which resulted in no significant findings. Thus, the U.S. Food and Drug Administration (FDA) has reportedly revoked the emergency authorisation it granted before.
Aside from the lack of notable improvements in patient recovery, there is growing evidence that shows the possibility of serious side effects. The drugs are originally intended to treat patients with malaria but have been allegedly observed to work against COVID-19.
However, several cases of individuals experiencing life-threatening heart complications quickly prompted health officials to reevaluate its use. According to the FDA, its unproven benefits, "do not outweigh the known and potential risks"
Another warning issued by the agency reminds doctors not to combine hydroxychloroquine or chloroquine with remdesivir. So far, the latter has been cleared by the FDA last month to be used for treatments. This was shortly after multiple tests show that it reduces the recovery period for COVID-19 by several days.
Aside from malaria, the two drugs are normally prescribed by doctors for patients with rheumatoid arthritis and lupus. Severely low blood pressure, arrhythmias, nerve/muscle damage, are just some of its notable side effects, as reported by ABC News.
The FDA reveals that there were approximately 390 reports wherein more than 100 are related to serious heart problems from the use of the antimalarial medication. The regulators will no longer distribute the federal government's stockpile of the drugs for use against COVID-19. Nevertheless, physicians are still allowed to prescribe it to treat other ailments as approved by the agency.
Meanwhile, former FDA associate commissioner Dr. Peter Lurie stated that "this is an agency that gains its credibility from the strength of its scientific pronouncements." He added "The lesson of this whole tawdry episode is that it's the old, painstaking ways of science that ultimately deliver safe and effective therapies." For now, the intravenous antiviral from Gilead Sciences remains the only approved drug treatment.
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