FDA Declines Authorization of Fluvoxamine SSRI for COVID Treatment

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Key Takeaways

  • The FDA declined the authorization of fluvoxamine as a treatment for COVID-19
  • Studies suggested that fluvoxamine, most often used as an antidepressant, could be used to treat COVID-19 in the early stages of the virus.
  • The FDA has said that more research might be warranted, so it's possible that the authorization status of fluvoxamine could change in the future.

As of May 16, The FDA has declined to authorize the antidepressant fluvoxamine (Luvox) as a treatment for COVID-19.

This decision comes after hopes that Fluvoxamine, part of the selective serotonin reuptake inhibitor class of antidepressants, could prevent severe COVID-19. They explained that there was not enough adequate evidence of the drug’s effectiveness for this purpose. However, they said that more clinical trials may be warranted.

The FDA said in a document published on Monday, May 16 that "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization.”

This information is important as some individuals with fluvoxamine prescriptions may have been under the impression the drug would also protect them from COVID-19.

The FDA Submission

The submission was based on a trial in Brazil involving around 1,500 patients. Researchers gave each patient either a placebo or 100mg of fluvoxamine twice daily for ten days. They found that those who received fluvoxamine early on were 32% less likely to need hospitalization or emergency care for more than six hours.

David Boulware, MD MPH, Professor of Medicine, Division of Infectious Diseases and International Medicine at the University of Minnesota Medical School, sent in the submission, in which he requested emergency use authorization for fluvoxamine in adults over 24 years old who have tested positive for COVID-19. 

In response to the submission, the FDA said that the benefit of the drug wasn’t persuasive – particularly when considering outcomes like hospitalizations and deaths. They also questioned whether the six-hour threshold was actually meaningful.

However, in Canada, Ontario’s COVID-19 Advisory has approved the drug for usage if other treatments are unavailable, but where treatments like sotrovimab (Xevudy) and remdesivir (Veklury) are available, and patients are eligible for them, they should be preferred.

What Is Fluvoxamine?

Fluvoxamine was first introduced in Switzerland almost 40 years ago. The FDA approved it in 1994, making it the first SSRI approved by the agency to treat obsessive-compulsive disorder. It’s also used in the US for social anxiety disorder, while around the world it’s variously used for or is effective in treating major depressive disorder, generalized anxiety disorder, panic disorder, and separation anxiety disorder.

Like any medication, fluvoxamine does have potential side effects. These include nausea, drowsiness, weakness, diarrhea, sweating, and sexual dysfunction.

As fluvoxamine is relatively affordable, there were hopes that it could be used as a cheap oral treatment for COVID-19 and reduce hospitalizations and deaths both in the US and across the world, but it looks as if more research is needed for this to be a possibility.

Exploring Potential Treatments for COVID-19

In trying to find effective treatments for COVID-19, scientists have been looking at ways to repurpose drugs already in use for treating other conditions. Through drug repurposing in the past, it was found that sildenafil (Viagra) could treat both erectile dysfunction and pulmonary hypertension, for example. Hence, researchers thought that fluvoxamine could have similarly been repurposed.

Dr. Boulware has responded to the FDA, describing their logic as being “inconsistent.” He has argued that fluvoxamine could still have its uses, such as with high-risk patients who may not be able to take Pfizer’s Paxlovid pill. He said that his request to authorize the drug is now less urgent, with the development of other treatments. However, he maintains that the evidence is there to suggest that it could be beneficial for some patients.

What This Means For You

Even if fluvoxamine does help to treat COVID-19, it's not a substitute for any precautions that people might be taking, like masking and social distancing, and more research is needed to determine whether it is effective in treating patients.

Most antiviral drugs either block the entry of the virus or block viral replication—when viruses form in host cells during the infection process. In contrast, fluvoxamine binds to the receptor that helps to regulate inflammation and immune signaling. It was thought that this might help patients to recover, and avoid the need for hospitalization.

As early as November 2020, it was suggested that fluvoxamine could be effective in treating people in the early stages of COVID-19. A study carried out in Missouri and Illinois involved patients taking either fluvoxamine or a placebo three times daily for 15 days, and patients taking fluvoxamine had a lower likelihood of their condition worsening than those taking the placebo. However, the sample size was small, with just 152 participants.

Researchers have conducted studies on other antidepressants too, and there have been suggestions that some of them may be effective in treating COVID-19 for some patients, but more research with larger sample sizes is needed.

While there is some evidence to suggest that fluvoxamine might be effective in treating COVID-19, more research is necessary, and it shouldn’t be seen as a substitute for COVID-19 treatments approved by the FDA, or for vaccinations and mask-wearing. People already taking fluvoxamine for a mental health condition shouldn’t assume that they’re being protected from COVID-19 – the body of evidence here is very light.

7 Sources
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  1. US Food and Drug Administration. Memorandum explaining basis for declining request for emergency use authorization of fluvoxamine maleate.

  2. Reis G, dos Santos Moreira-Silva EA, Silva DCM, et al. Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: The TOGETHER randomised, platform clinical trialLancet Glob Health. 2022;10(1):e42-e51. doi:10.1016/S2214-109X(21)00448-4

  3. Ontario COVID-19 Drugs and Biologics Clinical Practice Guidelines Working Group, University of Waterloo School of Pharmacy. Fluvoxamine: What prescribers and pharmacists need to know. Ontario COVID-19 Science Advisory Table; 2022. doi:10.47326/ocsat.2022.

  4. McCarthy MW. Repurposing approach of fluvoxamine for COVID-19Drugs Fut. 2021;46(10):813. doi:10.1358/dof.2021.46.10.3335978

  5. Medline Plus. Fluvoxamine.

  6. Hashimoto Y, Suzuki T, Hashimoto K. Mechanisms of action of fluvoxamine for COVID-19: A historical review. Mol Psychiatry. 2022;27(4):1898-1907. doi:10.1038/s41380-021-01432-3

  7. Lenze EJ, Mattar C, Zorumski CF, et al. Fluvoxamine vs placebo and clinical deterioration in outpatients with symptomatic COVID-19: A randomized clinical trial. JAMA. 2020;324(22):2292-2300. doi:10.1001/jama.2020.22760