Fluvoxamine is an oral antidepressant available by prescription in France under the trade name Floxyfral. It would reduce the risk of hospitalization due to Covid-19 by 30%. Efficacy, side effects, dosage… What we know to date about this drug.
At the end of January 2022, the Medicines Agency (ANSM) was approached by two health professionals specializing in psychiatry for a request to make fluvoxamine available in the curative treatment of Covid-19, in a framework of compassionate prescription (CPC). Due to their methodological limitations, the current data do not support a clinical benefit of fluvoxamine in curative treatment of Covid-19 disease. In a press release dated April 5, 2022the ANSM therefore cannot establish a compassionate prescribing framework for fluvoxamine in this indication, and emphasizes the need to implement large-scale comparative randomized clinical studies which could lead to the conclusion of the possible use of fluvoxamine against Covid-19. This position may be revised at any time, as soon as the results of clinical studies are likely, taking into account changes in standard care according to the target population, to modify the findings established to date.
Definition: what is fluvoxamine?
Fluvoxamine is an oral antidepressant of the family of serotonin reuptake inhibitors. It is indicated and prescribed in the treatment depressive states and obsessive compulsive disorders. This medicine is available only on medical prescription.
How effective is it against Covid-19?
According to the conclusions of a clinical trial published on October 27, 2021 in the Lancet Global Health, administration of fluvoxamine within 7 days of the onset of symptoms, to patients with one or more risk factors for severe COVID-19-related illness has reduced the proportion of patients requiring more than 6 hours of emergency care. Regarding the dose: treatment with fluvoxamine consisted of taking 100 mg twice daily for 10 days, the authors say. A few months earlier, the authors of thestudy co-led by McMaster University located in Ontario in Canada had already shown that the molecule fluvoxamine could reduce the risk of hospitalization following a Covid-19 infection by almost a third.
For now, only fluvoxamine showed a positive effect on Covid-19.
This clinical trial, the results of which are still preliminary, is part of the Together trial, which began in May 2020 and which aims to test eight drugs against Covid-19 including hydroxychloroquine, metformin, kaletra and ivermectin. For now, only fluvoxamine showed a positive effect on Covid-19. “It could be one of our strongest weapons against the virus and its effectiveness is one of the most important discoveries we have made since the start of the pandemic. What’s more, this cheap and easily accessible pill is a massive boon to public health, both in Canada and abroad, allowing hospitals to avoid costly and sometimes risky treatments“, argues researcher Ed Mills. These researchers will soon submit their findings to a medical journal for peer review. They have also submitted their research to the US-based National Institutes of Health and the World Health Organization ( WHO) Fluvoxamine has been used since the 1990s and its safety profile is well known. It was identified early in the pandemic for its ability to reduce cytokine storms, severe immune responses to COVID-19 that can cause severe or even fatal organ damage, the study authors remind.
What are the side effects of fluvoxamine?
Fluvoxamine, like all medicines, can cause potential unwanted side effects. These effects occur especially during the first weeks of treatment and usually fade thereafter.
>> Frequent side effects (more than 1% of patients): nausea, vomiting, abdominal pain, lack of appetite, diarrhoea, constipation, dry mouth, difficult digestion, fatigue, headache, agitation, anxiety, dizziness, drowsiness or on the contrary insomnia, tremors, sweat, palpitations, acceleration of heartbeat.
>> Uncommon side effects (less than 1% of patients): orthostatic hypotension, joint or muscle pain, confusion of ideas, sexual disorders, allergic skin reaction.
What is the trade name of fluvoxamine?
In France, fluvoxamine is marketed under the name Floxyfral®, which has as generics: Fluvoxamine Arrow® and Fluvoxamine Mylan®. The drug Floxyfral® is reimbursed at 65% by Social Security (list 1). The box of 30 tablets (50 mg) is sold at the price of €8.35 and the box of 15 tablets (100 mg) is sold at a price of 7.51 euros.
Is it available with or without a prescription?
Floxyfral® treatments and its generics are available exclusively on medical prescription and are reserved for an indication of major depressive episodes or obsessive-compulsive disorder (OCD). They are in no way available over the counter.
Source: Study Antidepressant fluvoxamine can save COVID-19 patients, McMaster-led research shows, McMaster University, August 17, 2021 / Effect of early treatment with fluvoxamine on risk of emergency care and hospitalization among patients with COVID-19: the TOGETHER randomised, platform clinical trial, The Lancet Global Health, 27 October 2021.