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FENFLURAMINE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • At a dose 4 times the maximum recommended dose, FINTEPLA did not prolong the QT interval when tested in an adult population.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
78
38381509

Odds Ratio = 0.0

Drug Property Information



ATC Code(s):
  • A08AA02 - fenfluramine
    • A08AA - Centrally acting antiobesity products
    • A08A - "ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS"
    • A08 - "ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS"
    • A - ALIMENTARY TRACT AND METABOLISM
  • N03AX26 - fenfluramine
    • N03AX - Other antiepileptics
    • N03A - ANTIEPILEPTICS
    • N03 - ANTIEPILEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:FENFLURAMINE
Active Ingredient UNII:2DS058H2CF
Drugbank ID:DB00574
PubChem Compound:3337
CTD ID:D005277
PharmGKB:PA449592
CAS Number:458-24-2
Dosage Form(s):solution
Route(s) Of Administrator:oral
Daily Dose:
  • 120.0 mg/day A08AA02
Chemical Structure:
SMILE Code:
CCNC(C)CC1=CC=CC(=C1)C(F)(F)F

Reference

1: Validation of a population-based method to assess drug-induced alterations in the QT interval: a self-controlled crossover study.

[Iribarren Carlos,Round Alfred D,Peng Jonathan A,Lu Meng,Zaroff Jonathan G,Holve Taylor J,Prasad Amit,Stang Paul]
Pharmacoepidemiol Drug Saf,2013 Nov;22(11):1222-32. PMID: 23857878

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