Fenfluramine, sold under the brand name Fintepla, is a serotonergic medication used for the treatment of seizures associated with Dravet syndrome and Lennox–Gastaut syndrome.[6][7][3] It was formerly used as an appetite suppressant in the treatment of obesity, but was discontinued for this use due to cardiovascular toxicity before being repurposed for new indications.[8][9] Fenfluramine was used for weight loss both alone under the brand name Pondimin and in combination with phentermine commonly known as fen-phen.[8][10][11]
Side effects of fenfluramine in people treated for seizures include decreased appetite, somnolence, sedation, lethargy, diarrhea, constipation, abnormal echocardiogram, fatigue, malaise, asthenia, ataxia, balance disorder, gait disturbance, increased blood pressure, drooling, excessive salivation, fever, upper respiratory tract infection, vomiting, appetite loss, weight loss, falls, and status epilepticus.[6] Fenfluramine acts as a serotonin releasing agent, agonist of the serotonin 5-HT2 receptors, and σ1 receptor positive modulator.[12][13][14] Its mechanism of action in the treatment of seizures is unknown,[6] but may involve increased activation of certain serotonin receptors and the σ1 receptor.[13][9][15]
Fenfluramine was developed in the early 1960s and was first introduced for medical use as an appetite suppressant in France in 1963 followed by approval in the United States in 1973.[8] In the 1990s, fenfluramine came to be associated with cardiovascular toxicity, and because of this, was withdrawn from the United States market in 1997.[8][16] Subsequently, it was repurposed for the treatment of seizures and was reintroduced in the United States and the European Union in 2020.[7][3][9] Fenfluramine was previously a schedule IV controlled substance in the United States.[7] However, the substance has since no-longer been subject to control pursuant to rule-making issued on 23 December 2022.[17]
^"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
^Anvisa (2023-07-24). "RDC Nº 804 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 804 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 2023-07-25). Archived from the original on 2023-08-27. Retrieved 2023-08-27.
^ abc"Fintepla EPAR". European Medicines Agency. 13 October 2020. Retrieved 8 January 2021.
^"Fintepla Product information". Union Register of medicinal products. Retrieved 3 March 2023.
^Cite error: The named reference Dart2004 was invoked but never defined (see the help page).
^ abc"FINTEPLA (fenfluramine) oral solution" (PDF). Zogenix Inc. U.S. Food and Drug Administration. March 2022.
^ abc"FDA Approves New Therapy for Dravet Syndrome". U.S. Food and Drug Administration (FDA) (Press release). 25 June 2020. Retrieved 25 June 2020. This article incorporates text from this source, which is in the public domain.
^ abcdCite error: The named reference Barceloux2012 was invoked but never defined (see the help page).
^ abcOdi R, Invernizzi RW, Gallily T, Bialer M, Perucca E (October 2021). "Fenfluramine repurposing from weight loss to epilepsy: What we do and do not know". Pharmacol Ther. 226: 107866. doi:10.1016/j.pharmthera.2021.107866. PMID 33895186.
^Swiss Pharmaceutical Society (2000). Swiss Pharmaceutical Society (ed.). Index Nominum 2000: International Drug Directory. Taylor & Francis. pp. 431–432. ISBN 978-3-88763-075-1.
^Kolata, Gina (September 23, 1997). "How Fen-Phen, A Diet 'Miracle,' Rose and Fell". New York Times. NY, NY, USA.
^Rothman RB, Baumann MH (2000). "Neurochemical mechanisms of phentermine and fenfluramine: Therapeutic and adverse effects". Drug Development Research. 51 (2): 52–65. doi:10.1002/1098-2299(200010)51:2<52::AID-DDR2>3.0.CO;2-H. eISSN 1098-2299. ISSN 0272-4391. S2CID 84029575.
^ abMartin P, Reeder T, Sourbron J, de Witte PA, Gammaitoni AR, Galer BS (August 2021). "An Emerging Role for Sigma-1 Receptors in the Treatment of Developmental and Epileptic Encephalopathies". Int J Mol Sci. 22 (16): 8416. doi:10.3390/ijms22168416. PMC 8395113. PMID 34445144.
^Cite error: The named reference pmid32169824 was invoked but never defined (see the help page).
^Polster T (February 2019). "Individualized treatment approaches: Fenfluramine, a novel antiepileptic medication for the treatment of seizures in Dravet syndrome". Epilepsy Behav. 91: 99–102. doi:10.1016/j.yebeh.2018.08.021. PMID 30269941. S2CID 52889559.
^Cite error: The named reference pmid11307869 was invoked but never defined (see the help page).
^"Schedules of Controlled Substances: Removal of Fenfluramine From Control". U.S. Federal Register. 23 December 2022.
Fenfluramine, sold under the brand name Fintepla, is a serotonergic medication used for the treatment of seizures associated with Dravet syndrome and Lennox–Gastaut...
hypertension or valvular heart disease, as the latter were caused by the fenfluramine component of the fen-phen drug combination. Use is not recommended during...
(−)-3-trifluoromethyl-N-ethylamphetamine, also known as (−)-fenfluramine or (R)-fenfluramine, is a drug of the amphetamine family that, itself (i.e., in...
amount of extracellular serotonin in the brain. It is the d-enantiomer of fenfluramine and is structurally similar to amphetamine, but lacks any psychologically...
catalyzes the breakdown of adenosine. Fenfluramine is an indirect agonist of serotonin receptors. Fenfluramine binds to the serotonin transporter, blocking...
an anorectic and hypolipidemic agent that is structurally related to fenfluramine (a substituted amphetamine). It may improve glycemic control and decrease...
the withdrawal of fenfluramine as an anorectic agent worldwide, and to the withdrawal of benfluorex in Europe, as both fenfluramine and benfluorex form...
effects profile similar to other withdrawn appetite suppressants such as fenfluramine and aminorex which were found to cause pulmonary hypertension and cardiac...
edema. Currently, no case of pulmonary hypertension has been noted. (Fenfluramine, of the 1990s "Fen-Phen" combo, forced excess release of neurotransmitters—a...
prepare. The drug combination fenfluramine/phentermine, usually called "fen-phen," was an anti-obesity treatment. Fenfluramine was marketed by Wyeth as Pondimin...
(the D-enantiomer of fenfluramine; withdrawn for the same reason as its racemate) Ephedrine (combinations) Etilamfetamine Fenfluramine† (one of the two components...
also agonize serotonin receptors such as those in the 5-HT2 subfamily. Fenfluramine, chlorphentermine, and aminorex, which are also amphetamines and relatives...
classically associated with the condition are weight loss drugs such as fenfluramine and chlorphentermine, and antiparkinson drugs such as pergolide and cabergoline...
cleared for sale by authorities. It was tested and found to contain fenfluramine and nicotinamide that was banned by authorities in several Asian countries...
of drug is a serotonin releasing agent (SRA), an example of which is fenfluramine. Many SRIs exist, an assortment of which are listed below. Note that...
3-Methylamphetamine 3-Methylmethcathinone 4-Methylmethamphetamine Fenfluramine 3,4-Dimethylamphetamine European Monitoring Centre for Drugs and Drug...
receptors, mCPP is a serotonin releasing agent similarly to agents like fenfluramine and MDMA. In contrast to these serotonin releasing agents however, mCPP...
therapy remains difficult: RCTs are now only available for the drugs fenfluramine (FFA), cannabidiol (CBD), and stiripentol (STP). A North American consensus...
1970s, but appears to have been abandoned. It is structurally related to fenfluramine and 4-MTA. Tiflorex went to phase II clinical trials. The extended release...
acts as a serotonin releasing agent (1–10 μM), similar in effect to fenfluramine. The serotonin releasing effects of tramadol could be blocked by sufficiently...
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