Back in 2021, we wrote about a drug that has flown below the radar: fluvoxamine for COVID. Investigators in Brazil had conducted a randomized controlled trial that included nearly 1500 people with COVID-19. Those taking fluvoxamine were less likely to be hospitalized or to die. Then a study published in JAMA Network Open, November 14, 2021 suggested that a chemical cousin, fluoxetine (Prozac), may also be beneficial. For a long while after that, we saw very little information about this medication. Experts agreed, however, that more trials conducted according to scientific principles would be needed.
An Update on Fluvoxamine for COVID:
Q. A year or two ago there was a 60 Minutes show about repurposed drugs for COVID. It suggested that an old antidepressant medication, fluvoxamine, might be helpful.
I have not heard anything more about fluvoxamine. Could you see where in development this drug is for treating COVID?
A. Other readers have also wondered what happened to research on fluvoxamine for COVID. This chemical cousin of fluoxetine was marketed in Switzerland as an antidepressant in 1984. The FDA approved it for treating OCD (obsessive compulsive disorder) in 1994 as Luvox (fluvoxamine).
A pilot study involving 152 COVID patients suggested that this drug might be beneficial against SARS-CoV-2 (JAMA, Nov. 12, 2020). In contrast, a much larger trial involving 1,288 COVID patients recently determined that fluvoxamine “did not improve time to sustained recovery” (JAMA, Jan. 12, 2023). The authors concluded that the data do not support the use of this medication against COVID-19.
According to the investigators:
“These findings do not support the use of fluvoxamine at this dose and duration in patients with mild to moderate COVID-19.”
That leaves a bit of wiggle room for other doses or durations, but from now on, doctors will probably not be using fluvoxamine for COVID.
History of Fluvoxamine:
Fluvoxamine is an SSRI (selective serotonin re-uptake inhibitor). That’s a mouthful, but if I say Prozac-like drug, you should instantly recognize a category of medications that revolutionized the treatment of depression.
Eli Lilly launched Prozac, also known as fluoxetine (please note the name similarity with fluvoxamine) in January 1988. It became the most prescribed antidepressant in the US, if not the world. Prozac turned into a household word.
Luvox (fluvoxamine), on the other hand, has flown below the radar. Solvay Pharmaceuticals in Switzerland actually marketed fluvoxamine in 1984 under the brand name Floxyfral. In other words, it beat Prozac to the international market by four years.
In Europe and many other countries, doctors have long prescribed fluvoxamine for depression. That’s not the case in the US. The brand Luvox was launched in the United States in 1994 exclusively for the treatment of OCD (obsessive compulsive disorder).
The brand name drug Luvox is no longer on the market. That may be in part because of a tale of woe and intrigue associated with the Columbine high school shootings. The shooter, Eric Harris, was taking Luvox for his OCD when he committed that atrocity. The brand name drug disappeared from the market in 2002. Generic fluvoxamine continues to be available by a number of manufacturers at a very reasonable price.
Enough History! What About Fluvoxamine for COVID?
We got interested in fluvoxamine for COVID after watching a segment on 60 Minutes (March 7, 2021) titled:
“Finding a Possible Early Treatment for COVID-19 in a 40-Year-Old Antidepressant.”
There was also a preliminary study published in JAMA, Nov. 12, 2020). It was titled:
The authors concluded their report with this statement:
“In this preliminary study of adult outpatients with symptomatic COVID-19, patients treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days. However, the study is limited by a small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.”
Other Research on Fluvoxamine for COVID:
I wrote about fluvoxamine for COVID back on March 23, 2021. I pointed out that the JAMA study “disappeared almost without a trace.” You can read that article and learn more about fluvoxamine side effects at this link.
Will the Antidepressant Fluvoxamine Fight COVID-19?
Fluvoxamine (Luvox) has been marketed as an antidepressant since 1984. Why would this very old SSRI offer some promise against COVID-19?
While ivermectin captured headlines and ignited passions, fluvoxamine remained virtually invisible. Nevertheless, the research continued.
Fluvoxamine for COVID (The Lancet):
The results of a large randomized controlled trial (RCT) were published in The Lancet (Oct. 27, 2021). Scientists conducted the study at 11 clinical sites in Brazil. There were 741 patients in the fluvoxamine arm and 756 patients “allocated” to placebo.
The researchers reported:
“This is, to the best of our knowledge, the first large, randomised controlled trial to test the efficacy of fluvoxamine for acute treatment of COVID-19. We found a clinically important absolute risk reduction of 5·0%, and 32% RR [relative risk] reduction, on the primary outcome of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19, consequent on the administration of fluvoxamine for 10 days.”
“Our trial has found that fluvoxamine, an inexpensive existing drug, reduces the need for advanced disease care in this high-risk population. A 10-day course of fluvoxamine costs approximately US$4 even in well-resourced settings. Our study compares favourably with the treatment effects of more expensive treatments including monoclonal antibodies for outpatient treatment.”
“There were 17 deaths in the fluvoxamine group and 25 deaths in the placebo group in the primary intention-to-treat analysis. There was one death in the fluvoxamine group and 12 in the placebo group for the per-protocol population.”
The Bottom Line “Interpretation” in The Lancet:
“Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital.”
The People’s Pharmacy Perspective on Fluvoxamine for COVID:
Scientists published the original study of fluvoxamine for COVID in JAMA on November 12, 2020. At that time I described the side effects of fluvoxamine here.
I concluded with these final words:
“We are eager to see more well-controlled trials of medications against COVID-19. Just because we have several vaccines that look promising does not mean we should stop searching for effective antiviral medications or immune system modulators. If vaccines ever stop working, it would be extremely helpful to have drugs to treat complications of the coronavirus waiting in the wings.”
At that point, I felt much more optimistic about fluvoxamine for COVID. After all, two randomized controlled trials had suggested that the drug is working against the coronavirus. The most recent one was large enough to be meaningful.
Some Reservations Remained:
To be sure, the authors of The Lancet study admitted that “The underlying mechanism of fluvoxamine for COVID-19 disease remains uncertain.” They posited that the drug might have anti-inflammatory activity. In addition, the antiplatelet activity of the drug might prevent blood clots. Further, the drug raises melatonin levels in the body, and melatonin may be helpful against COVID-19.
Whatever the mechanism, more research on fluvoxamine and fluoxetine for COVID was certainly warranted. These drugs are incredibly affordable. We wished that the FDA and/or the CDC would make some statement to guide health care providers in their use to treat COVID.
A Big Disappointment:
Obviously, I was very hopeful that further research would confirm the benefits of fluvoxamine for COVID. Now, unfortunately, the evidence is quite strong that this medication does not make an important difference for patients’ recovery. As a result, I must conclude that doctors should NOT be prescribing fluvoxamine to their COVID patients.
What Do You Think?
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