Story at a glance
- Hydroxychloroquine has still not been approved by the Food and Drug Administration as a treatment for COVID-19.
- The FDA issued a limited emergency use authorization with guidance for dosages of the drug.
- An update to the CDC website removes dosage guidelines for chloroquine, among other drugs.
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There are no drugs or other therapeutics approved by the U.S. Food and Drug Administration (FDA) to prevent or treat COVID-19, according to the Centers for Disease Control and Prevention (CDC). Still, President Donald Trump and other government officials have been touting hydroxychloroquine and chloroquine as potential treatments for the novel coronavirus.
Now, updated guidance from the CDC has removed previously issued dosage recommendations. Without evidence that the drugs are even effective against COVID-19, it’s unclear what dosages can be administered safely. Still, states are continuing to collect doses of the oral prescription drugs.
How did we get here?
Hydroxychloroquine and chloroquine are generally used to treat malaria and some inflammatory conditions, including lupus. But after anecdotal evidence suggested it could be used to treat the coronavirus, the FDA issued an Emergency Use Authorization to allow supplies of the drug to be withdrawn from the national stockpile for some adults and adolescents weighing more than 110 pounds with COVID-19 who weren’t participating in ongoing clinical trials for the drug.
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Pharmaceutical company Amneal has donated 200,000 doses of hydroxychloroquine to the Georgia Department of Public Health, U.S. Rep. Doug Collins said in a tweet. Meanwhile, Florida Gov. Ron DeSantis said the state is receiving a million doses of the drug. It is unclear what guidelines the states are using to define a single dose.
What does the science say?
Studies conducted in France and China suggest the drug can be used to treat coronavirus patients have not been peer reviewed and consist of sample sizes of just 30-36 patients. At the same time, another preprint published in a French medical journal claims there is no evidence of rapid antiviral clearance or clinic benefit with the combination of hydroxychloroquine and azithromycin in patients with severe COVID-19 infection.
These findings have not yet been reviewed by other experts in the field for quality and accuracy, which means there could be significant flaws not yet identified in the research. An unpublished paper from scientists in India erroneously reported a link between COVID–19 and HIV and has since been withdrawn. Harvard epidemiology Marc Lipsitch and Bill Hanage advise journalists and health officials in an essay to use caution when citing these findings.
The CDC update on April 7 of information for clinicians on therapeutic options for patients with COVID-19 also removed similar guidance for several other drugs under investigation in clinical trials, including remdesivir.
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Published on Apr 08,2020