The FDA has added a black box warning for this drug in reference to increased risks of suicidal thinking and behavior in young adults and children. A study from the Institute for Safe Medication Practices identified reports of violence from those taking fluvoxamine as being 8.4 times higher than expected given the volume of overall reports for that drug. (Five reports of violence.)
Fluvoxamine's only FDA approved indication is in the treatment of obsessive-compulsive disorder (OCD), although in other countries (e.g. Australia and the UK) it has indications for major depressive disorder as well. Fluvoxamine has been found to be useful in the treatment of major depressive disorder (MDD), and anxiety disorders such as panic disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and obsessive-compulsive spectrum disorders. Fluvoxamine is indicated for children and adolescents with OCD. The drug works long-term, with research showing that fluvoxamine retains its therapeutic efficacy for at least a year. It has also been found to possess some analgesic properties in line with other SSRIs and tricyclic antidepressants.
There is some evidence that fluvoxamine may be a helpful adjunct in the treatment of schizophrenia, improving the depressive, negative and cognitive symptoms of the disorder. Its actions at the sigma receptor may afford it a unique advantage among antidepressants in treating the cognitive symptoms of schizophrenia.
Fluvoxamine shares a number of adverse effects with other SSRIs. These side effects include the following: Gastrointestinal side effects are more common in those receiving fluvoxamine than with other SSRIs.
Fluvoxamine was developed by Kali-Duphar, part of Solvay Pharmaceuticals, Belgium, now Abbott Laboratories, and introduced as Floxyfral in Switzerland in 1983 and Solvay in West Germany in the same year. It was approved by the FDA on 5 Dec, 1994 and introduced as Luvox in the US. In India it is available, among several other brands, as Uvox by Abbott. It was one of the first SSRI antidepressants to be launched and is prescribed to patients with major depression in many countries. It was the first SSRI, a non-TCA drug, approved by the U.S. Food and Drug Administration specifically for the treatment of OCD. At the end of 1995, more than ten million patients worldwide had been treated with fluvoxamine. Fluvoxamine was the first SSRI to be registered for the treatment of obsessive compulsive disorder in children by the FDA in 1997. In Japan, fluvoxamine was the first SSRI to be approved for the treatment of depression in 1999 and was later in 2005 the first drug to be approved for the treatment of social anxiety disorder. Fluvoxamine was the first SSRI approved for clinical use in the United Kingdom.
In 1999, fluvoxamine came under great public scrutiny after it was discovered that Eric Harris, one of the two teenage shooters involved in the Columbine High School massacre, had been taking the drug after switching from sertraline (Zoloft). Many immediately pointed fingers at fluvoxamine and its manufacturer Solvay Pharmaceuticals. Sales fell, and Solvay withdrew the medication from the U.S. market in 2002. In 2007, Solvay re-introduced Luvox to the U.S. market, which is now manufactured by Palo Alto, California-based Jazz Pharmaceuticals, Inc. On February 28, 2008, the FDA approved a controlled-release formulation of fluvoxamine for Solvay Pharmaceuticals, to be marketed as Luvox CR.
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^ abcAustralian Medicines Handbook (2013 ed.). Adelaide: The Australian Medicines Handbook Unit Trust. 2013. ISBN9780980579093.edit
^ abcJoint Formulary Committee (2013). British National Formulary (BNF) (65 ed.). London, UK: Pharmaceutical Press. ISBN9780857110848.edit
^US-FDA Fluvoxamine Product Insert. March 2005.Cite uses deprecated parameters (help)
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^Schreiber, S; Pick CG (August 2006). "From selective to highly selective SSRIs: A comparison of the antinociceptive properties of fluoxetine, fluvoxamine, citalopram and escitalopram". European Neuropsychopharmacology16 (6): 464–468. doi:10.1016/j.euroneuro.2005.11.013. PMID16413173.Cite uses deprecated parameters (help)
^Coquoz, D; Porchet HC, Dayer P (September 1993). "Central analgesic effects of desipramine, fluvoxamine, and moclobemide after single oral dosing: a study in healthy volunteers". Clinical Pharmacology and Therapeutics54 (3): 339–344. doi:10.1038/clpt.1993.156. PMID8375130.Cite uses deprecated parameters (help)
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^ abHindmarch, I; Hashimoto, K (April 2010). "Cognition and depression: the effects of fluvoxamine, a sigma-1 receptor agonist, reconsidered". Human Psychopharmacology: Clinical and Experimental25 (3): 193–200. doi:10.1002/hup.1106. PMID20373470.
^ abTaylor, D; Paton, C; Shitij, K (2012). The Maudsley prescribing guidelines in psychiatry (in English). West Sussex: Wiley-Blackwell. ISBN978-0-470-97948-8.Cite uses deprecated parameters (help)edit
^ ab"Sigma-1 receptors and selective serotonin reuptake inhibitors: clinical implications of their relationship". Central Nervous System Agents in Medicinal Chemistry9 (3): 197–204. September 2009. doi:10.2174/1871524910909030197. PMID20021354.