A generic antidepressant may be able to keep COVID-19 patients out of the hospital, though it’s unclear whether the cheap and readily available pill will be made part of the pandemic medicine cabinet.
The latest findings come from a review of three rigorous clinical trials conducted in Brazil, Canada, and the U.S. that points to a tie between fluvoxamine and a reduced risk of hospitalizations, according to the research, which was published April 6 in JAMA Network Open.
The studies enrolled a total of 2,196 patients, though most of the data came from the Together trial, which had 1,497 participants. These were all placebo-controlled, randomized trials that enrolled adults who had tested positive within six to seven days of infection, were unvaccinated, had symptoms, and did not require oxygen.
“Fluvoxamine is an immediately available, safe, and inexpensive management option with a high probability of moderate efficacy,” the researchers concluded.
Fluvoxamine is a selective serotonin reuptake inhibitor that is approved by the Food and Drug Administration to treat obsessive-compulsive disorder. It’s also often prescribed to treat depression. Because the drug can produce an anti-inflammatory response, it can ward off the kind of inflammation that worsens a COVID-19 infection.
“It’s one of the drugs I’m excited about,” said Dr. Carlos del Rio, a professor of infectious diseases at the Emory University School of Medicine. “I’m excited to see further results. I’m still not convinced it’s a game-changer.”
Infectious disease physicians like del Rio are paying close attention to fluvoxamine, though some remain cautious about overstating the potential benefits of a drug three years into a pandemic beset by misinformation and sometimes lacking clinical data about COVID-19 vaccines and medications.
Del Rio said he has considered prescribing fluvoxamine but has not yet done so. “I’ve been tempted in a couple of cases,” he said.
The interest in fluvoxamine may be tempered by the controversies surrounding hydroxychloroquine and ivermectin, two generic drugs that were held up as COVID-19 cures before the science established that neither pill reduces hospitalizations among those who have tested positive for the virus. The FDA allowed emergency use of hydroxychloroquine in the early days of the pandemic before revoking the authorization three months later. And, unlike ivermectin, which became a political lightning rod that dominated headlines and social media feeds for much of 2021, fluvoxamine has some steady, albeit quiet, support among some players in the U.S. health care system.
“The problem is other medicines like fluvoxamine actually have good data,” said Dr. David Boulware, an infectious disease doctor at the University of Minnesota Medical School who’s running a study evaluating several generic drugs including fluvoxamine and ivermectin as COVID-19 treatments. (He is also one of the authors of the JAMA Network Open review.)
The case for fluvoxamine
Late last year, a group of clinicians including Boulware requested that the FDA authorize fluvoxamine as a COVID-19 treatment. (This is a rare thing for health care providers to do. It’s usually drug makers that initiate approval or authorization requests to the regulator.)
“There’s no financial incentive for me to do that,” Boulware said. “It’s taking four days out of my time to do it because I think it’s the right thing to do.”
An FDA spokesperson declined to comment on the authorization request, saying it cannot “confirm, deny or comment” on authorization applications. (Abbott Laboratories
which makes a version of fluvoxamine called Luvox, said it isn’t involved in any of the COVID-19 studies but is “closely monitoring progress in research and treatment guidelines based on ongoing studies, including studies related to the use of fluvoxamine in COVID-19.”)
The Institute for Clinical and Economic Review, a watchdog organization that studies the cost-effectiveness of drugs, earlier this year included fluvoxamine in a recent review of COVID-19 treatments. It ranked fluvoxamine of equal benefit to Lagevrio, Merck & Co. Inc.’s
authorized COVID-19 antiviral.
“We were aware of the emerging evidence on it,” Sarah Emond, ICER’s chief operating officer, told MarketWatch in an email in February, “and as part of our usual scoping process determined that it was high priority for inclusion along with other emerging oral treatment options.”
There are a handful of new drugs authorized in the U.S. to treat COVID-19, including Lagevrio, which is also referred to as molnupiravir; Pfizer Inc.’s
antiviral, Paxlovid; Gilead Sciences Inc.’s
Veklury; and the monoclonal antibodies developed by AstraZeneca
Eli Lilly & Co.
Regeneron Pharmaceuticals Inc.
and Vir Biotechnology Inc.
Few COVID-19 treatment guidelines include fluvoxamine
Hospitals and clinics in the U.S. are split on whether to prescribe fluvoxamine to COVID-19 patients right now. Barnes-Jewish Hospital in St. Louis prescribes it, as does Johns Hopkins Medicine, which added fluvoxamine to its COVID-19 treatment recommendations in November.
However, the National Institutes of Health doesn’t recommend fluvoxamine, citing insufficient evidence, and the World Health Organization says the drug is currently under consideration. It’s not being prescribed at the UCSF hospital network, the Veterans Health Administration, or at the Cleveland Clinic.
“Based on existing data, this is not something that we feel needs to be looked at as a standard of care for patients with COVID,” said Dr. Abhijit Duggal, vice chair of critical care at the Cleveland Clinic. “In the day and age of COVID, there’s a lot of things that have been introduced based on data that would not have really stood the test of scientific rigor in any other situation.”
Back in early 2020, scientists around the world threw dozens of therapies, molecules, or vitamins at the wall, in the hope that one or some of them could potentially treat a disease with no proven therapies at that time.
Researchers were particularly interested in testing generic drugs that are inexpensive, available around the world, and already deemed safe by regulators. Some drugs, like dexamethasone, showed in rigorous clinical trials that they work, while others including hydroxychloroquine and ivermectin failed to prove they’re effective COVID-19 treatments in clinical trials.
“Fluvoxamine would be a much better choice,” del Rio said.