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March 5, 2024

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There have been recommendations for using Luvox (fluvoxamine) for the treatment of COVID.1 Years ago, it became apparent to me that fluvoxamine was the most dangerous SSRI antidepressant, causing high rates of mania and psychosis, and incidents of suicide and violence. In 2002, I wrote a report about Luvox for the International Journal of Risk & Safety in Medicine,2 where I marshaled considerable evidence for its dangerous array of adverse psychiatric events. I also summarized a single case report from the literature:

A single case study of a 17-year-old youngster taking fluvoxamine provides a window into what happened to Eric Harris.3 The youth, in this case, was mildly retarded when he became depressed and anxious and was started on a 50 mg dose of fluvoxamine. After a single dose, he developed “increasing agitation and insomnia.” Then, “In the next 24 hours, he displayed auditory and visual hallucinations, a fearful mood, and paranoid delusions involving statements that ‘the devil will get me’”. He required hospitalization and was treated with antipsychotic drugs.

Although fluvoxamine in the treatment of COVID-19 is recommended for only ten days, that relatively short period may not prevent its worst adverse psychiatric effects, which often occur early in treatment, as well as during changes of doses.4

The FDA-approved Full Prescribing Information for fluvoxamine warns:5

“All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.”

The above generic warning was based partly on my own review of SSRI adverse psychiatric events, which the FDA distributed to all the FDA committee members who reviewed the existing warnings and upgraded them circa 1994.6 In my article, I documented evidence that “Mania with psychosis is the extreme end of a stimulant continuum that often begins with lesser degrees of insomnia, nervousness, anxiety, hyperactivity and irritability and then progresses toward more severe agitation, aggression, and varying degrees of mania” (p. 32).

Remarkably, the same Full Prescribing Information lists the following serious neuropsychiatric reactions as “frequent:”Nervous System: Frequent: amnesia, apathy, hyperkinesia, hypokinesia, manic reaction, myoclonus, psychotic reaction.” In addition to many other physical adverse outcomes, Luvox can also cause a potentially lethal serotonin syndrome and, more rarely, neuroleptic malignant syndrome. This is not the profile of a relatively safe drug. It’s the profile of a drug that should never have obtained FDA approval.

Overall Adverse Neuropsychiatric Effects of COVID-19

Patients with COVID-19 commonly experience mental disturbances, including depression: “Over 30% of patients hospitalized with COVID-19 may exhibit cognitive impairment, depression, and anxiety that persist for months after discharge. These symptoms are even more common in patients who required intensive care for severe effects of the virus.”7 These same effects can be caused by or worsened by viral illnesses in general.8

SSRI antidepressants have no actual or specific capacity to improve depression, such as feelings of hopelessness, despair, self-blame, and suicide. They simply blunt all emotions. In some people, this leads to more despair and suicide. Or the individual develops a drug-induced severe psychomotor agitation, which can also drive someone to despair, suicide, and violence.9 Therefore, an SSRI like fluvoxamine cannot be expected to improve, and might drastically worsen, the neuropsychiatric condition of COVID-19 patients by adding its neurotoxicity to their already compromised brain function.

Columbine Shooter Eric Harris Was Taking Luvox

Eric Harris, the Columbine shooter, was on Luvox, taking prescribed increasing doses for many months right up to his suicide at the end of the Columbine shootings. I was a legal, medical expert in cases related to the Columbine shootings and was empowered to read his medical records. Although major news outlets have denied that Harris was taking any psychiatric drugs at the time of the mass murders, his coroner’s report states that Harris had a “therapeutic” drug level of fluvoxamine in his blood.10 I have made the coroner’s report available.11

Dosage Issues

The Brazil study of Luvox for COVID-19 published in the Lancet used 100 mg twice daily or 200 mg daily. This compares to a range of 50 to 300 mg for Luvox in the FDA-approved label for adults. The 300 mg is considered high, and the label makes clear that’s the limit. The typical dose of Luvox in psychiatry is probably 200 mg (or less) — the same as in the Lancet COVID-19 treatment study.

The daily dose of 200 mg is the dose Eric Harris was taking at the time he committed mass murder at Columbine. Also, we would expect COVID-19 patients to be much more vulnerable to adverse reactions at any dose than psychiatric patients because COVID-19 patients often have severe neurological disorders compromising their brain function.

Based on the Lancet study, there is no difference between the Luvox dosage for COVID-19 and for psychiatric disorders. But even if some clinicians are using one-quarter the standard psychiatric dose, that would be about 50 mg, which is the starting dose for psychiatric treatment, and anything but harmless. All the dose schedules drawn to my attention are actually above 50 mg daily, which is the starter dose for adults. For children, the starter dose is only 25 mg. It seems probable that the rumor that much smaller doses of Luvox are used to treat COVID-19 than in psychiatric treatment is another one of those falsehoods that get circulated to promote a bad idea.

Solvay Withdraws Its FDA Approval of Luvox in the U.S.

In 2003, Solvay and the FDA agreed to withdraw the trademarked distribution of Luvox in the U.S., while both protested very loudly that it was not for “safety” reasons.12 Only the generic remains available.

Conclusion

Despite some claims, fluvoxamine, in contrast to two commonly used drugs, hydroxychloroquine, and ivermectin, does not have a long record of safety.13 Nor does it have anywhere near as many positive controlled clinical trials for treating COVID-19 as the two commonly used medications.

Mainly based on safety issues, fluvoxamine should not be recommended and should be avoided for the treatment of COVID-19.

References:

1 https://www.sciencenews.org/article/covid-antidepressant-fluvoxamine-drug-hospital-death. The study is at:

2 Breggin, Peter. “Fluvoxamine as a cause of stimulation, mania, and aggression with a critical analysis of the FDA-approved label.” International Journal of Risk and Safety in Medicine, 14: 71-86, 2002. Simultaneously published in Ethical Human Sciences and Services, 4, 211-227, 2002. https://breggin.com/article-detail/post_detail/fluvoxamine-as-a-cause-of-stimulation-mania-and-aggression-2002

3 F. Sim, A single dose of fluvoxamine associated with an acute psychotic reaction, Canadian Journal of Psychiatry 45 (2000), 762.

4 The authors believe that fluvoxamine caused the acute psychosis.

5 https://duckduckgo.com/?q=FDA-approved+label+for+Luvox&t=newext&atb=v338-1&ia=web

6 Breggin, Peter. (2003/2004). “Suicidality, violence and mania caused by selective serotonin reuptake inhibitors (SSRIs): A review and analysis.” International Journal of Risk and Safety in Medicine, 16: 31-49. Simultaneously published in Ethical Human Sciences and Services, 5:225-246. https://breggin.com/article-detail/post_detail/suicidality-violence-and-mania-caused-by-selective-serotonin-reuptake-inhibitors –  https://www.madinamerica.com/wp-content/uploads/2016/11/Breggin-PRSuicidality-caused-by-SSRIs-Int-J-Risk-Safety-Medicine-2004.pdf

7 https://pubmed.ncbi.nlm.nih.gov/33725218/

8 https://pubmed.ncbi.nlm.nih.gov/29287239/

9 Breggin, Peter. (2013). Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists, Patients and their Families.  New York: Springer Publishing Company.  Also see, Breggin, Peter. (2003/2004). “Suicidality, violence and mania caused by selective serotonin reuptake inhibitors (SSRIs): A review and analysis.” International Journal of Risk and Safety in Medicine, 16: 31-49, 2003/2004. Simultaneously published in Ethical Human Sciences and Services, 5:225-246.  For reviews of antidepressant ineffectiveness, see my Antidepressant Resource Center: https://breggin.com/Antidepressant-Drugs-Scientific-Resources

10 https://extras.denverpost.com/news/shot0504e.htm. I also have the Solvay’s report to the FDA about Eric Harris confirming he had a “therapeutic” level of the drug in his blood. In my forensic experience, blood levels taken at autopsy do not necessarily reflect the actual level in the living person, but the data does confirm with certainty he had a significant blood level of the medication at the time of death and had recently taken the medication.

11 Go to https://breggin.com/Antidepressant-Drugs-Scientific-Resources. Use Control F to search for Eric Harris.  See the “continuation” on the second page.

12 https://www.federalregister.gov/documents/2003/09/03/03-22359/solvay-pharmaceuticals-inc-withdrawal-of-approval-of-two-new-drug-applications-determination-that

13 vFluvoxamine as a Cause of Stimulation, Mania, and Aggression: A Critical Analysis of the FDA-Approved Label | Semantic Scholar

MANY VOICES, ONE FREEDOM: UNITED IN THE 1ST AMENDMENT

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