Benfluorex

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Benfluorex
Clinical data
Routes of; administration	Oral
ATC code	C10AX04 (WHO) ;
Pharmacokinetic data
Excretion	Renal
Identifiers
	IUPAC name 2-[1-[3-(trifluoromethyl)phenyl]propan-2-ylamino]; ethyl benzoate;
CAS Number	23602-78-0;
PubChem CID	2318;
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
Formula	C19H20F3NO2
Molar mass	351.363 g/mol

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

Benfluorex is an anorectic and hypolipidemic agent that is structurally related to fenfluramine patented and manufactured by a French pharmaceutical company Servier. Two clinical studies have shown it may improve glycemic control and decrease insulin resistance in people with poorly controlled type 2 diabetes.^[1]^[2] However, Servier is suspected of having marketed Mediator (benfluorex) at odds with the drug's medical properties.^[3]

Drug withdrawn

On 18 December 2009, the European Medicines Agency (EMEA) recommended the withdrawal of all medicines containing benfluorex in the European Union, because their risks, particularly the risk of heart valve disease (fenfluramine-like cardiovascular side-effects), are greater than their benefits.^[4] Thus Frachon et al. showed a significantly higher prevalence of unexplained valvular heart disease in patients taking benfluorex compared to controls.^[5] and Weill et al. looked at over 1 million diabetic patients demonstrating a higher hospitalization rate in benfluorex takers for valvular heart disease.^[6]

In France the medication had been marketed as by Servier as an adjuvant antidiabetic under the name Mediator. The drug was on the market between 1976 and 2009 and is thought to have caused between 500 – 2,000 deaths.^[7] The drug was also used in Spain (trade name, Modulator), Portugal and Cyprus.

Fenfluramine, a related drug, had been withdrawn from the market in 1997 after reports of heart valve disease,^[8]^[9] pulmonary hypertension, and development of cardiac fibrosis. This side effect is mediated by the metabolite norfenfluramine on 5HT_2B receptors of heart valves (Rothman et al., Circulation 2000), leading to a characteristic pattern of heart failure following proliferation of cardiac fibroblasts on the tricuspid valve. Both fenfluramine and benfluorex form norfenfluramine as a metabolite. This side effect led to the withdrawal of fenfluramine as an anorectic drug worldwide, and later to the withdrawal of benfluorex in Europe.

References

↑ Moulin, P.; Andre, M.; Alawi, H.; dos Santos, L. C.; Khalid, A. K.; Koev, D.; Moore, R.; Serban, V.; et al. (2006). "Efficacy of Benfluorex in Combination with Sulfonylurea in Type 2 Diabetic Patients: An 18-Week, Randomized, Double-Blind Study". Diabetes Care. 29 (3): 515–520. doi:10.2337/diacare.29.03.06.dc05-1439. PMID 16505498.
↑ Roger, P.; Auclair, J.; Drain, P. (1999). "Addition of Benfluorex to Biguanide Improves Glycemic Control in Obese Non-Insulin-Dependent Diabetes: A Double-Blind Study versus Placebo". Journal of Diabetes and its Complications. 13 (2): 62–67. doi:10.1016/S1056-8727(98)00004-X. PMID 10432168.
↑ Mullard, A. (2011). "Mediator Scandal Rocks French Medical Community" (pdf). Lancet. 377 (9769): 890–892. doi:10.1016/s0140-6736(11)60334-6. PMID 21409784.
↑ "European Medicines Agency recommends withdrawal of benfluorex from the market in European Union" (pdf). European Medicines Agency. 2009-12-18.
↑ PMID 20405030 (PMID 20405030)
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↑ PMID 20945504 (PMID 20945504)
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↑ "France braced for diabetic drug scandal report". BBC News. 2011-01-11.
↑ Connolly, H. M.; Crary, J. L.; McGoon, M. D.; Hensrud, D. D.; Edwards, B. S.; Edwards, W. D.; Schaff, H. V. (1997). "Valvular Heart Disease Associated with Fenfluramine-Phentermine". New England Journal of Medicine. 337 (9): 581–588. doi:10.1056/NEJM199708283370901. PMID 9271479.
↑ Weissman, N. J. (2001). "Appetite Suppressants and Valvular Heart Disease". American Journal of the Medical Sciences. 321 (4): 285–291. doi:10.1097/00000441-200104000-00008. PMID 11307869.

10. Rothman RB, Baumann MH, Savage JE, Rauser L, McBride A, Hufeisen SJ, Roth BL.(2000). "Evidence for possible involvement of 5-HT(2B) receptors in the cardiac valvulopathy associated with fenfluramine and other serotonergic medications." Circulation 102(23):2836-41. PMID 11104741

Template:Anorectics

Template:Lipid modifying agents Template:Monoaminergics Template:Phenethylamines

[1] Moulin, P.; Andre, M.; Alawi, H.; dos Santos, L. C.; Khalid, A. K.; Koev, D.; Moore, R.; Serban, V.; et al. (2006). "Efficacy of Benfluorex in Combination with Sulfonylurea in Type 2 Diabetic Patients: An 18-Week, Randomized, Double-Blind Study". Diabetes Care. 29 (3): 515–520. doi:10.2337/diacare.29.03.06.dc05-1439. PMID 16505498.

[2] Roger, P.; Auclair, J.; Drain, P. (1999). "Addition of Benfluorex to Biguanide Improves Glycemic Control in Obese Non-Insulin-Dependent Diabetes: A Double-Blind Study versus Placebo". Journal of Diabetes and its Complications. 13 (2): 62–67. doi:10.1016/S1056-8727(98)00004-X. PMID 10432168.

[3] Mullard, A. (2011). "Mediator Scandal Rocks French Medical Community" (pdf). Lancet. 377 (9769): 890–892. doi:10.1016/s0140-6736(11)60334-6. PMID 21409784.

[4] "European Medicines Agency recommends withdrawal of benfluorex from the market in European Union" (pdf). European Medicines Agency. 2009-12-18.

[5] PMID 20405030 (PMID 20405030)
Citation will be completed automatically in a few minutes. Jump the queue or expand by hand

[6] PMID 20945504 (PMID 20945504)
Citation will be completed automatically in a few minutes. Jump the queue or expand by hand

[7] "France braced for diabetic drug scandal report". BBC News. 2011-01-11.

[pmid9271479-8] Connolly, H. M.; Crary, J. L.; McGoon, M. D.; Hensrud, D. D.; Edwards, B. S.; Edwards, W. D.; Schaff, H. V. (1997). "Valvular Heart Disease Associated with Fenfluramine-Phentermine". New England Journal of Medicine. 337 (9): 581–588. doi:10.1056/NEJM199708283370901. PMID 9271479.

[pmid11307869-9] Weissman, N. J. (2001). "Appetite Suppressants and Valvular Heart Disease". American Journal of the Medical Sciences. 321 (4): 285–291. doi:10.1097/00000441-200104000-00008. PMID 11307869.

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v t e Oral antidiabetic drugs and Insulin analogs (A10)
Biguanides	Metformin
Sulfonylureas	Chlorpropamide, Glibenclamide (Glyburide), Gliclazide, Glimepiride, Glipizide, Gliquidone, Tolazamide, Tolbutamide
Alpha-glucosidase inhibitors	Acarbose, Miglitol, Voglibose
Thiazolidinediones (TZD)	Pioglitazone, Rivoglitazone^†, Rosiglitazone, Troglitazone^‡
Meglitinides	Nateglinide, Repaglinide, Mitiglinide
Dipeptidyl peptidase-4 (DPP-4) inhibitors	Alogliptin^†, Saxagliptin^†, Sitagliptin, Vildagliptin, Linagliptin^†
Glucagon-like peptide-1 analog	Exenatide, Liraglutide^†, Albiglutide^†
Amylin analog	Pramlintide
Insulin analogs	fast acting (Insulin lispro, Insulin aspart, Insulin glulisine), long acting (Insulin glargine, Insulin detemir)
Dual PPAR agonists	Aleglitazar^†, Muraglitazar^§, Tesaglitazar^§
SGLT2 inhibitor	Dapagliflozin^†, Remogliflozin^†
^†Undergoing clinical trials. ^‡ Withdrawn from market. ^§Development halted.

Clinical data

Routes of administration	Oral
ATC code	C10AX04 (WHO)
Pharmacokinetic data
Excretion	Renal
Identifiers
IUPAC name 2-[1-[3-(trifluoromethyl)phenyl]propan-2-ylamino] ethyl benzoate
CAS Number	23602-78-0
PubChem CID	2318
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
Formula	C₁₉H₂₀F₃NO₂
Molar mass	351.363 g/mol

Benfluorex

Overview

Drug withdrawn

References

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