FDA: Fluvoxamine Doesn’t Treat COVID-19 – And Here Are 27 Pages Why

When the U.S. Food and Drug Administration rejected an antidepressant as a treatment for COVID-19 on Monday, it also released a 27-page memorandum explaining exactly why it wasn’t convinced the drug was effective. It’s an unusual move for the agency, which usually quietly rejects drugs without all the publicly available paperwork.

The antidepressant fluvoxamine is an inexpensive, generic drug that has been used for decades. Research shows that the drug can also block inflammation in the body. So some researchers hoped it could help prevent severe symptoms in patients with COVID-19, some of whom are dealing with inflammation due to an overactive immune system.

Some small and preliminary studies have shown that it may potentially reduce the risk of patients with COVID-19 becoming seriously ill. But that research wasn’t enough to convince the FDA. The agency said in its memorandum that the studies submitted in support of the drug didn’t do enough to show it could provide “clinically meaningful results” — reductions in hospitalizations and deaths. The main study, called the Together trial, found that the drug reduced a patient’s chance of staying in the emergency room for more than six hours. The FDA was unsure that metrics were important.

It’s unusual to get this kind of window into the FDA’s decision-making process when it rejects a drug. Usually, the decision goes to the pharmaceutical company that made the drug, and it is kept confidential. Research shows that those companies often don’t announce rejections, and when they do, they don’t say publicly why. However, people do want to know: A survey of adults in the United States published in February found that nearly 90 percent said they would like information about why a drug was not approved to be made public.

Notably, the use of fluvoxamine as a COVID-19 treatment was not sent to the FDA by a drug company — a group of doctors asked the agency for approval. Since it is an old and generic drug, no pharmaceutical company would benefit from putting it through the expensive regulatory process.

One of those doctors, David Boulware, an infectious disease physician at the University of Minnesota, criticized the FDA’s rejection, telling: STAT it was “inconsequential”. He noted that the coronavirus antiviral paxlovid is more effective, but it is not widely available to people in low- and middle-income countries. “It’s not my first choice as a doctor, but I should have the option,” Boulware said.

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