Zachary Cohen and Arman Azad, CNN
The FDA made clear Friday that the drug has not been shown to be “safe and effective for treating or preventing Covid-19,” and carries “known risks” of potentially deadly heart complications. The FDA said those risks “may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial,” which is mentioned in an emergency-use authorization for the drugs issued last month.
“While clinical trials are ongoing to determine the safety and effectiveness of these drugs for Covid-19,” the FDA said on Friday, “there are known side effects of these medications that should be considered.”
The FDA’s warning comes just days after CNN previously reported on a study conducted at VA medical centers that showed coronavirus patients taking hydroxychloroquine were no less likely to need mechanical ventilation and had higher deaths rates compared to those who did not take the drug. That study was based the treatment of hundreds of patients at US Veterans Health Administration medical centers.
But when asked whether — in the wake of the FDA’s warning and the study done on veterans — the VA believes its patients should use hydroxychloroquine going forward, spokeswoman Christina Noel said the VA is using “it to treat Covid-19 in cases where Veteran patients and their providers determine it is medically necessary, and in a manner consistent with current FDA guidance.”
She pointed to a part of the FDA guidance that allows the drug to be used for treatment temporarily during the pandemic in hospitalized patients.
The study, publicly reported on Tuesday, focused on 368 patients. Ninety-seven patients who took hydroxychloroquine had a 27.8% death rate. The 158 patients who did not take the drug had an 11.4% death rate.
The study, which reviewed veterans’ medical charts, was posted Tuesday on medrxiv.org, a pre-print server, meaning it was not peer reviewed or published in a medical journal. The research was funded by the National Institutes of Health and the University of Virginia.
“In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19,” the authors wrote.
There are currently no products approved by the US Food and Drug Administration to prevent or treat Covid-19, although research is underway on many drugs.