New York, May 17 – The US Food and Drug Administration has declined to approve antidepressant fluvoxamine as a treatment for Covid-19 as data is insufficient to conclude its effectiveness against the virus.
Fluvoxamine has been a low-cost and safe drug typically used in forms of depression and related disorders. Some studies claimed that the drug has the potential to reduce the cytokine storm in Covid-19 patients. Cytokine storms are severe immune responses to Covid-19 that can cause potentially lethal organ damage.
But the drug regulator, in a document, stated: “Based on the review of available scientific evidence, the FDA has determined that the data is insufficient to conclude that fluvoxamine may be effective in the treatment of non-hospitalised patients with Covid-19 to prevent progression to severe disease and/or hospitalisation.”
“Therefore, FDA has determined that the criteria for issuance of an EUA are not met and is declining to issue an EUA covering fluvoxamine for the treatment of Covid-19 at this time,” it added.
Currently, fluvoxamine is FDA-approved for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) in children 8-17 years of age and adults.
But in December, 2021, Dr. David R Boulware, a professor at University of Minnesota in the US, submitted a request to the FDA to grant emergency use authorization (EUA) to fluvoxamine for the outpatient treatment of Covid positive persons above 24 years of age to prevent progression to severe disease and/or hospitalisation.
The agency said it reviewed available information derived from several clinical trials investigating the use of fluvoxamine for the treatment of Covid-19.
It noted that “the treatment benefit of fluvoxamine was not persuasive when focusing on clinically meaningful outcomes”, meaning no reduction in hospitalisations and deaths.
Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI), currently used to treat mental health conditions such as depression and obsessive-compulsive disorders. It has been used since the 1990s for various conditions and its safety profile is well-known.